Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-01-01 @ 4:53 AM
Study NCT ID:
NCT04740905
Status:
COMPLETED
Last Update Posted:
2024-08-06
First Post:
2021-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008269', 'term': 'Macular Edema'}, {'id': 'D012170', 'term': 'Retinal Vein Occlusion'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723200', 'term': 'faricimab'}, {'id': 'C533178', 'term': 'aflibercept'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72', 'description': 'Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A: Faricimab Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).', 'otherNumAtRisk': 276, 'deathsNumAtRisk': 276, 'otherNumAffected': 62, 'seriousNumAtRisk': 276, 'deathsNumAffected': 1, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Arm B: Aflibercept Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).', 'otherNumAtRisk': 274, 'deathsNumAtRisk': 274, 'otherNumAffected': 69, 'seriousNumAtRisk': 274, 'deathsNumAffected': 0, 'seriousNumAffected': 17}, {'id': 'EG002', 'title': 'Arm A: Faricimab Q4W to Faricimab PTI (Part 2)', 'description': 'In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).', 'otherNumAtRisk': 270, 'deathsNumAtRisk': 270, 'otherNumAffected': 92, 'seriousNumAtRisk': 270, 'deathsNumAffected': 1, 'seriousNumAffected': 29}, {'id': 'EG003', 'title': 'Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)', 'description': 'In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).', 'otherNumAtRisk': 267, 'deathsNumAtRisk': 267, 'otherNumAffected': 87, 'seriousNumAtRisk': 267, 'deathsNumAffected': 2, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Conjunctival haemorrhage', 'notes': 'AEs occurred in the study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Dry eye', 'notes': 'AEs occurred in the study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Cataract', 'notes': 'AEs occurred in the study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Vitreous detachment', 'notes': 'AEs occurred in the study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Retinal vein occlusion', 'notes': 'AEs occurred in the study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Intraocular pressure increased', 'notes': 'AEs occurred in the study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 21, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Vitreous floaters', 'notes': 'AEs occurred in the study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Macular oedema', 'notes': 'AEs occurred in the study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Retinal ischaemia', 'notes': 'AEs occurred in the study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Retinal vein occlusion', 'notes': 'AEs occurred in the study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Vitreous haemorrhage', 'notes': 'AEs occurred in the study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Multiple sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Glomerulonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 1, 'numAffected': 1}, {'groupId': 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267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Device malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Renal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}], 'classes': [{'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000', 'lowerLimit': '15.7', 'upperLimit': '18.1'}, {'value': '17.5', 'groupId': 'OG001', 'lowerLimit': '16.3', 'upperLimit': '18.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Adjusted Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '1.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.84', 'estimateComment': 'The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.', 'groupDescription': 'The null hypothesis, H0: μ(faricimab) - μ(aflibercept) ≤-4 letters; the alternative hypothesis, Ha: μ(faricimab) - μ(aflibercept) \\>-4 letters. The final sample size provided \\>90% power for the non-inferiority assessment (at a one-sided 0.02485 significance level).', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'If the lower bound of a two-sided 95% confidence interval (CI) for the difference in adjusted means of the two treatments (faricimab minus aflibercept) is greater than -4 letters (the non-inferiority margin), then faricimab is considered non-inferior to aflibercept.'}, {'pValue': '0.4978', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Adjusted Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '1.1', 'pValueComment': 'Tested at a two-sided 0.0497 significance level.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.84', 'estimateComment': 'The treatment difference in adjusted means of change from baseline BCVA is the calculated difference of Arm A: Faricimab and Arm B: Aflibercept. MMRM adjustments are listed in the outcome measure description.', 'groupDescription': 'The final sample size provided \\>80% power for a 3.5-letter superiority assessment of faricimab over aflibercept.', 'statisticalMethod': 'Mixed Model of Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline through Week 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'ETDRS Letters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '12.5'}, {'value': '12.4', 'groupId': 'OG001', 'lowerLimit': '11.4', 'upperLimit': '13.4'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000', 'lowerLimit': '12.6', 'upperLimit': '14.7'}, {'value': '15.1', 'groupId': 'OG001', 'lowerLimit': '14.1', 'upperLimit': '16.2'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000', 'lowerLimit': '14.0', 'upperLimit': '16.2'}, {'value': '15.9', 'groupId': 'OG001', 'lowerLimit': '14.8', 'upperLimit': '17.0'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000', 'lowerLimit': '14.4', 'upperLimit': '16.6'}, {'value': '16.5', 'groupId': 'OG001', 'lowerLimit': '15.4', 'upperLimit': '17.7'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000', 'lowerLimit': '15.2', 'upperLimit': '17.4'}, {'value': '17.3', 'groupId': 'OG001', 'lowerLimit': '16.1', 'upperLimit': '18.4'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000', 'lowerLimit': '15.7', 'upperLimit': '18.1'}, {'value': '17.5', 'groupId': 'OG001', 'lowerLimit': '16.3', 'upperLimit': '18.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'ETDRS Letters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}], 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'groupId': 'OG000', 'lowerLimit': '50.4', 'upperLimit': '61.9'}, {'value': '60.4', 'groupId': 'OG001', 'lowerLimit': '54.7', 'upperLimit': '66.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in CMH Weighted Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.3', 'ciLowerLimit': '-12.3', 'ciUpperLimit': '3.8', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000', 'lowerLimit': '28.9', 'upperLimit': '39.8'}, {'value': '36.9', 'groupId': 'OG001', 'lowerLimit': '31.5', 'upperLimit': '42.3'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000', 'lowerLimit': '35.6', 'upperLimit': '46.9'}, {'value': '46.7', 'groupId': 'OG001', 'lowerLimit': '41.0', 'upperLimit': '52.3'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000', 'lowerLimit': '45.3', 'upperLimit': '56.7'}, {'value': '52.1', 'groupId': 'OG001', 'lowerLimit': '46.3', 'upperLimit': '57.8'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '53.6', 'groupId': 'OG000', 'lowerLimit': '47.8', 'upperLimit': '59.3'}, {'value': '56.4', 'groupId': 'OG001', 'lowerLimit': '50.8', 'upperLimit': '62.1'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '56.1', 'groupId': 'OG000', 'lowerLimit': '50.3', 'upperLimit': '61.8'}, {'value': '58.9', 'groupId': 'OG001', 'lowerLimit': '53.3', 'upperLimit': '64.6'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '56.1', 'groupId': 'OG000', 'lowerLimit': '50.4', 'upperLimit': '61.9'}, {'value': '60.4', 'groupId': 'OG001', 'lowerLimit': '54.7', 'upperLimit': '66.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '57.5', 'groupId': 'OG000', 'lowerLimit': '51.8', 'upperLimit': '63.3'}, {'value': '59.2', 'groupId': 'OG001', 'lowerLimit': '53.6', 'upperLimit': '64.9'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '69.1', 'groupId': 'OG000', 'lowerLimit': '63.8', 'upperLimit': '74.5'}, {'value': '69.0', 'groupId': 'OG001', 'lowerLimit': '63.6', 'upperLimit': '74.4'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '69.9', 'upperLimit': '80.1'}, {'value': '74.8', 'groupId': 'OG001', 'lowerLimit': '69.7', 'upperLimit': '79.8'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '72.1', 'groupId': 'OG000', 'lowerLimit': '66.9', 'upperLimit': '77.3'}, {'value': '76.6', 'groupId': 'OG001', 'lowerLimit': '71.6', 'upperLimit': '81.5'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '75.3', 'groupId': 'OG000', 'lowerLimit': '70.3', 'upperLimit': '80.4'}, {'value': '79.1', 'groupId': 'OG001', 'lowerLimit': '74.3', 'upperLimit': '83.9'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '77.5', 'groupId': 'OG000', 'lowerLimit': '72.6', 'upperLimit': '82.4'}, {'value': '77.3', 'groupId': 'OG001', 'lowerLimit': '72.4', 'upperLimit': '82.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '75.7', 'groupId': 'OG000', 'lowerLimit': '70.7', 'upperLimit': '80.7'}, {'value': '79.1', 'groupId': 'OG001', 'lowerLimit': '74.4', 'upperLimit': '83.9'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '84.0', 'groupId': 'OG000', 'lowerLimit': '79.7', 'upperLimit': '88.3'}, {'value': '88.1', 'groupId': 'OG001', 'lowerLimit': '84.3', 'upperLimit': '91.9'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '87.0', 'groupId': 'OG000', 'lowerLimit': '83.1', 'upperLimit': '90.9'}, {'value': '87.0', 'groupId': 'OG001', 'lowerLimit': '83.1', 'upperLimit': '91.0'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '85.9', 'groupId': 'OG000', 'lowerLimit': '81.8', 'upperLimit': '89.9'}, {'value': '88.8', 'groupId': 'OG001', 'lowerLimit': '85.1', 'upperLimit': '92.5'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000', 'lowerLimit': '84.6', 'upperLimit': '92.2'}, {'value': '90.3', 'groupId': 'OG001', 'lowerLimit': '86.8', 'upperLimit': '93.7'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000', 'lowerLimit': '87.6', 'upperLimit': '94.3'}, {'value': '89.6', 'groupId': 'OG001', 'lowerLimit': '86.0', 'upperLimit': '93.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '90.2', 'groupId': 'OG000', 'lowerLimit': '86.8', 'upperLimit': '93.6'}, {'value': '93.2', 'groupId': 'OG001', 'lowerLimit': '90.3', 'upperLimit': '96.1'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '92.7', 'groupId': 'OG000', 'lowerLimit': '89.7', 'upperLimit': '95.8'}, {'value': '96.8', 'groupId': 'OG001', 'lowerLimit': '94.7', 'upperLimit': '98.8'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000', 'lowerLimit': '92.4', 'upperLimit': '97.5'}, {'value': '94.2', 'groupId': 'OG001', 'lowerLimit': '91.5', 'upperLimit': '97.0'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '93.8', 'groupId': 'OG000', 'lowerLimit': '91.1', 'upperLimit': '96.6'}, {'value': '94.9', 'groupId': 'OG001', 'lowerLimit': '92.4', 'upperLimit': '97.5'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000', 'lowerLimit': '92.4', 'upperLimit': '97.5'}, {'value': '96.0', 'groupId': 'OG001', 'lowerLimit': '93.8', 'upperLimit': '98.3'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '94.2', 'upperLimit': '98.6'}, {'value': '95.3', 'groupId': 'OG001', 'lowerLimit': '92.9', 'upperLimit': '97.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '98.3', 'upperLimit': '100.0'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '98.3', 'upperLimit': '100.0'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '98.3', 'upperLimit': '100.0'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '98.3', 'upperLimit': '100.0'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '99.9'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '98.9', 'upperLimit': '100.0'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '99.9'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '98.9', 'upperLimit': '100.0'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '99.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '97.1', 'upperLimit': '99.9'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '97.1', 'upperLimit': '100.0'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '97.1', 'upperLimit': '99.9'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '97.1', 'upperLimit': '99.9'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '96.7', 'upperLimit': '99.7'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '98.3', 'upperLimit': '100.0'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '99.9'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '98.9', 'upperLimit': '100.0'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '96.7', 'upperLimit': '99.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '95.1', 'upperLimit': '99.1'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '99.9'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000', 'lowerLimit': '96.1', 'upperLimit': '99.5'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '99.9'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000', 'lowerLimit': '96.1', 'upperLimit': '99.5'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000', 'lowerLimit': '96.1', 'upperLimit': '99.5'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '96.7', 'upperLimit': '99.7'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '97.1', 'upperLimit': '99.9'}, {'value': '97.8', 'groupId': 'OG001', 'lowerLimit': '96.2', 'upperLimit': '99.5'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100.0'}, {'value': '97.5', 'groupId': 'OG001', 'lowerLimit': '95.7', 'upperLimit': '99.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '11.9'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '11.8'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000', 'lowerLimit': '10.3', 'upperLimit': '18.0'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '11.5', 'upperLimit': '19.5'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000', 'lowerLimit': '11.7', 'upperLimit': '19.6'}, {'value': '20.2', 'groupId': 'OG001', 'lowerLimit': '15.7', 'upperLimit': '24.6'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000', 'lowerLimit': '13.3', 'upperLimit': '21.6'}, {'value': '22.0', 'groupId': 'OG001', 'lowerLimit': '17.4', 'upperLimit': '26.5'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '20.7', 'groupId': 'OG000', 'lowerLimit': '16.2', 'upperLimit': '25.2'}, {'value': '23.8', 'groupId': 'OG001', 'lowerLimit': '19.0', 'upperLimit': '28.5'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '22.9', 'groupId': 'OG000', 'lowerLimit': '18.2', 'upperLimit': '27.6'}, {'value': '23.8', 'groupId': 'OG001', 'lowerLimit': '19.1', 'upperLimit': '28.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '50.6', 'upperLimit': '60.5'}, {'value': '62.3', 'groupId': 'OG001', 'lowerLimit': '57.3', 'upperLimit': '67.3'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '63.9', 'groupId': 'OG000', 'lowerLimit': '59.3', 'upperLimit': '68.6'}, {'value': '70.3', 'groupId': 'OG001', 'lowerLimit': '65.7', 'upperLimit': '74.9'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000', 'lowerLimit': '64.4', 'upperLimit': '73.6'}, {'value': '69.2', 'groupId': 'OG001', 'lowerLimit': '64.4', 'upperLimit': '74.0'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '72.2', 'groupId': 'OG000', 'lowerLimit': '67.7', 'upperLimit': '76.8'}, {'value': '72.1', 'groupId': 'OG001', 'lowerLimit': '67.5', 'upperLimit': '76.8'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000', 'lowerLimit': '69.1', 'upperLimit': '77.6'}, {'value': '76.1', 'groupId': 'OG001', 'lowerLimit': '71.7', 'upperLimit': '80.5'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '73.7', 'groupId': 'OG000', 'lowerLimit': '69.3', 'upperLimit': '78.1'}, {'value': '76.5', 'groupId': 'OG001', 'lowerLimit': '71.9', 'upperLimit': '81.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '5.3'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '2.9'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '5.0'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '3.3'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '3.8'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '2.8'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '3.8'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '3.3'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '3.8'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '3.3'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '3.8'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '3.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (\\>38 and ≤38 letters) and region (U.S. and Canada, Asia, and rest of the world). All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Part 1: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-283.9', 'groupId': 'OG000', 'lowerLimit': '-290.1', 'upperLimit': '-277.8'}, {'value': '-281.1', 'groupId': 'OG001', 'lowerLimit': '-287.2', 'upperLimit': '-274.9'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-299.4', 'groupId': 'OG000', 'lowerLimit': '-305.2', 'upperLimit': '-293.7'}, {'value': '-296.9', 'groupId': 'OG001', 'lowerLimit': '-302.6', 'upperLimit': '-291.2'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-304.4', 'groupId': 'OG000', 'lowerLimit': '-309.7', 'upperLimit': '-299.1'}, {'value': '-298.8', 'groupId': 'OG001', 'lowerLimit': '-304.1', 'upperLimit': '-293.5'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-306.1', 'groupId': 'OG000', 'lowerLimit': '-311.5', 'upperLimit': '-300.8'}, {'value': '-301.4', 'groupId': 'OG001', 'lowerLimit': '-306.7', 'upperLimit': '-296.1'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-307.3', 'groupId': 'OG000', 'lowerLimit': '-312.5', 'upperLimit': '-302.1'}, {'value': '-302.2', 'groupId': 'OG001', 'lowerLimit': '-307.4', 'upperLimit': '-297.0'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-311.4', 'groupId': 'OG000', 'lowerLimit': '-316.4', 'upperLimit': '-306.4'}, {'value': '-304.4', 'groupId': 'OG001', 'lowerLimit': '-309.3', 'upperLimit': '-299.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline CST (continuous), and randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'microns', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '88.8', 'groupId': 'OG000', 'lowerLimit': '85.1', 'upperLimit': '92.5'}, {'value': '88.1', 'groupId': 'OG001', 'lowerLimit': '84.4', 'upperLimit': '91.9'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '94.5', 'groupId': 'OG000', 'lowerLimit': '91.9', 'upperLimit': '97.2'}, {'value': '93.2', 'groupId': 'OG001', 'lowerLimit': '90.3', 'upperLimit': '96.1'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '94.2', 'upperLimit': '98.5'}, {'value': '92.1', 'groupId': 'OG001', 'lowerLimit': '89.0', 'upperLimit': '95.2'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000', 'lowerLimit': '92.8', 'upperLimit': '97.7'}, {'value': '93.6', 'groupId': 'OG001', 'lowerLimit': '90.7', 'upperLimit': '96.4'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000', 'lowerLimit': '93.7', 'upperLimit': '98.3'}, {'value': '94.6', 'groupId': 'OG001', 'lowerLimit': '92.1', 'upperLimit': '97.2'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000', 'lowerLimit': '92.8', 'upperLimit': '97.7'}, {'value': '93.9', 'groupId': 'OG001', 'lowerLimit': '91.2', 'upperLimit': '96.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': "Absence of diabetic macular edema was defined as achieving a central subfield thickness of \\<325 microns in the study eye. Central subfield thickness was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '46.1', 'groupId': 'OG000', 'lowerLimit': '40.2', 'upperLimit': '51.9'}, {'value': '54.8', 'groupId': 'OG001', 'lowerLimit': '49.0', 'upperLimit': '60.6'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000', 'lowerLimit': '48.2', 'upperLimit': '59.4'}, {'value': '57.4', 'groupId': 'OG001', 'lowerLimit': '51.6', 'upperLimit': '63.1'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '65.3', 'groupId': 'OG000', 'lowerLimit': '59.7', 'upperLimit': '70.8'}, {'value': '56.6', 'groupId': 'OG001', 'lowerLimit': '50.8', 'upperLimit': '62.4'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '69.9', 'groupId': 'OG000', 'lowerLimit': '64.6', 'upperLimit': '75.3'}, {'value': '72.9', 'groupId': 'OG001', 'lowerLimit': '67.8', 'upperLimit': '78.1'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '67.1', 'groupId': 'OG000', 'lowerLimit': '61.6', 'upperLimit': '72.6'}, {'value': '66.4', 'groupId': 'OG001', 'lowerLimit': '60.9', 'upperLimit': '71.9'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '72.5', 'groupId': 'OG000', 'lowerLimit': '67.3', 'upperLimit': '77.7'}, {'value': '66.0', 'groupId': 'OG001', 'lowerLimit': '60.5', 'upperLimit': '71.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Intraretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '76.1', 'groupId': 'OG000', 'lowerLimit': '71.1', 'upperLimit': '81.1'}, {'value': '72.9', 'groupId': 'OG001', 'lowerLimit': '67.8', 'upperLimit': '78.1'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '93.1', 'groupId': 'OG000', 'lowerLimit': '90.2', 'upperLimit': '96.1'}, {'value': '91.4', 'groupId': 'OG001', 'lowerLimit': '88.1', 'upperLimit': '94.6'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '94.2', 'upperLimit': '98.6'}, {'value': '97.1', 'groupId': 'OG001', 'lowerLimit': '95.2', 'upperLimit': '99.1'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000', 'lowerLimit': '92.8', 'upperLimit': '97.8'}, {'value': '96.4', 'groupId': 'OG001', 'lowerLimit': '94.2', 'upperLimit': '98.6'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '99.8'}, {'value': '97.8', 'groupId': 'OG001', 'lowerLimit': '96.1', 'upperLimit': '99.5'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '91.3', 'groupId': 'OG000', 'lowerLimit': '88.0', 'upperLimit': '94.6'}, {'value': '90.3', 'groupId': 'OG001', 'lowerLimit': '86.9', 'upperLimit': '93.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Subretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Part 1: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '37.8', 'groupId': 'OG000', 'lowerLimit': '32.1', 'upperLimit': '43.4'}, {'value': '40.8', 'groupId': 'OG001', 'lowerLimit': '35.2', 'upperLimit': '46.4'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '50.9', 'groupId': 'OG000', 'lowerLimit': '45.3', 'upperLimit': '56.5'}, {'value': '54.1', 'groupId': 'OG001', 'lowerLimit': '48.4', 'upperLimit': '59.9'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '63.8', 'groupId': 'OG000', 'lowerLimit': '58.2', 'upperLimit': '69.4'}, {'value': '56.3', 'groupId': 'OG001', 'lowerLimit': '50.5', 'upperLimit': '62.1'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '67.1', 'groupId': 'OG000', 'lowerLimit': '61.6', 'upperLimit': '72.6'}, {'value': '72.6', 'groupId': 'OG001', 'lowerLimit': '67.4', 'upperLimit': '77.8'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '66.0', 'groupId': 'OG000', 'lowerLimit': '60.5', 'upperLimit': '71.5'}, {'value': '66.0', 'groupId': 'OG001', 'lowerLimit': '60.5', 'upperLimit': '71.6'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '66.3', 'groupId': 'OG000', 'lowerLimit': '60.8', 'upperLimit': '71.9'}, {'value': '61.0', 'groupId': 'OG001', 'lowerLimit': '55.3', 'upperLimit': '66.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Intraretinal fluid and subretinal fluid were measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Part 1: Change From Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '6.7'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '7.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Adjusted Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '1.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.76', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': "The NEI VFQ-25 captures a patient's perception of vision-related functioning and vision-related quality of life. The core measure includes 25 items that comprise 11 vision-related subscales and 1 item on general health. The composite score ranges from 0 to 100, with higher scores indicating better vision-related functioning. For the ANCOVA analysis, the model uses the non-missing change from baseline in BCVA at Weeks 24 as the response variables adjusted for the treatment group, baseline NEI VFQ-25 Composite Score (continuous), baseline BCVA score (≥55 and ≤54 letters) and region (U.S. and Canada, Asia, and the rest of the world). Observed NEI VFQ-25 assessments were used regardless of the occurrence of intercurrent events. Missing data were not imputed. 95% CI is a rounding of 95.03% CI.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Only participants with non-missing Baseline and Week 24 assessments were included for analysis.'}, {'type': 'SECONDARY', 'title': 'Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '12.5'}, {'value': '12.4', 'groupId': 'OG001', 'lowerLimit': '11.4', 'upperLimit': '13.4'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000', 'lowerLimit': '12.6', 'upperLimit': '14.7'}, {'value': '15.1', 'groupId': 'OG001', 'lowerLimit': '14.1', 'upperLimit': '16.2'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000', 'lowerLimit': '14.0', 'upperLimit': '16.1'}, {'value': '15.9', 'groupId': 'OG001', 'lowerLimit': '14.8', 'upperLimit': '17.0'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000', 'lowerLimit': '14.4', 'upperLimit': '16.6'}, {'value': '16.5', 'groupId': 'OG001', 'lowerLimit': '15.4', 'upperLimit': '17.6'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000', 'lowerLimit': '15.1', 'upperLimit': '17.4'}, {'value': '17.2', 'groupId': 'OG001', 'lowerLimit': '16.1', 'upperLimit': '18.4'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG000', 'lowerLimit': '15.6', 'upperLimit': '17.9'}, {'value': '17.5', 'groupId': 'OG001', 'lowerLimit': '16.3', 'upperLimit': '18.6'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000', 'lowerLimit': '15.3', 'upperLimit': '17.6'}, {'value': '17.3', 'groupId': 'OG001', 'lowerLimit': '16.2', 'upperLimit': '18.4'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '17.2', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '18.4'}, {'value': '17.5', 'groupId': 'OG001', 'lowerLimit': '16.3', 'upperLimit': '18.7'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '17.3', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '18.4'}, {'value': '18.0', 'groupId': 'OG001', 'lowerLimit': '16.8', 'upperLimit': '19.2'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '17.3', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '18.4'}, {'value': '17.7', 'groupId': 'OG001', 'lowerLimit': '16.6', 'upperLimit': '18.9'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000', 'lowerLimit': '16.8', 'upperLimit': '19.3'}, {'value': '17.7', 'groupId': 'OG001', 'lowerLimit': '16.5', 'upperLimit': '18.9'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '16.8', 'upperLimit': '19.3'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '17.0', 'upperLimit': '19.4'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '16.7', 'upperLimit': '19.3'}, {'value': '18.4', 'groupId': 'OG001', 'lowerLimit': '17.1', 'upperLimit': '19.7'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '17.3', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '18.6'}, {'value': '18.1', 'groupId': 'OG001', 'lowerLimit': '16.8', 'upperLimit': '19.4'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '16.7', 'upperLimit': '19.3'}, {'value': '18.6', 'groupId': 'OG001', 'lowerLimit': '17.3', 'upperLimit': '19.8'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000', 'lowerLimit': '16.6', 'upperLimit': '19.2'}, {'value': '18.6', 'groupId': 'OG001', 'lowerLimit': '17.3', 'upperLimit': '19.9'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000', 'lowerLimit': '16.8', 'upperLimit': '19.4'}, {'value': '18.8', 'groupId': 'OG001', 'lowerLimit': '17.5', 'upperLimit': '20.1'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000', 'lowerLimit': '17.1', 'upperLimit': '19.7'}, {'value': '18.8', 'groupId': 'OG001', 'lowerLimit': '17.5', 'upperLimit': '20.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'ETDRS Letters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000', 'lowerLimit': '28.9', 'upperLimit': '39.8'}, {'value': '36.9', 'groupId': 'OG001', 'lowerLimit': '31.5', 'upperLimit': '42.3'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000', 'lowerLimit': '35.6', 'upperLimit': '46.9'}, {'value': '46.7', 'groupId': 'OG001', 'lowerLimit': '41.0', 'upperLimit': '52.3'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000', 'lowerLimit': '45.3', 'upperLimit': '56.7'}, {'value': '52.1', 'groupId': 'OG001', 'lowerLimit': '46.3', 'upperLimit': '57.8'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '53.6', 'groupId': 'OG000', 'lowerLimit': '47.8', 'upperLimit': '59.3'}, {'value': '56.4', 'groupId': 'OG001', 'lowerLimit': '50.8', 'upperLimit': '62.1'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '56.1', 'groupId': 'OG000', 'lowerLimit': '50.3', 'upperLimit': '61.8'}, {'value': '58.9', 'groupId': 'OG001', 'lowerLimit': '53.3', 'upperLimit': '64.6'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '56.1', 'groupId': 'OG000', 'lowerLimit': '50.4', 'upperLimit': '61.9'}, {'value': '60.4', 'groupId': 'OG001', 'lowerLimit': '54.7', 'upperLimit': '66.0'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '55.8', 'groupId': 'OG000', 'lowerLimit': '50.0', 'upperLimit': '61.5'}, {'value': '61.8', 'groupId': 'OG001', 'lowerLimit': '56.2', 'upperLimit': '67.4'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '59.0', 'groupId': 'OG000', 'lowerLimit': '53.3', 'upperLimit': '64.6'}, {'value': '61.4', 'groupId': 'OG001', 'lowerLimit': '55.8', 'upperLimit': '67.1'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '61.2', 'groupId': 'OG000', 'lowerLimit': '55.5', 'upperLimit': '66.8'}, {'value': '62.5', 'groupId': 'OG001', 'lowerLimit': '56.9', 'upperLimit': '68.1'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '60.8', 'groupId': 'OG000', 'lowerLimit': '55.2', 'upperLimit': '66.4'}, {'value': '61.1', 'groupId': 'OG001', 'lowerLimit': '55.4', 'upperLimit': '66.7'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '65.5', 'groupId': 'OG000', 'lowerLimit': '60.1', 'upperLimit': '71.0'}, {'value': '58.9', 'groupId': 'OG001', 'lowerLimit': '53.4', 'upperLimit': '64.5'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '64.1', 'groupId': 'OG000', 'lowerLimit': '58.5', 'upperLimit': '69.6'}, {'value': '60.7', 'groupId': 'OG001', 'lowerLimit': '55.1', 'upperLimit': '66.3'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '61.2', 'groupId': 'OG000', 'lowerLimit': '55.6', 'upperLimit': '66.8'}, {'value': '64.0', 'groupId': 'OG001', 'lowerLimit': '58.4', 'upperLimit': '69.5'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '57.9', 'groupId': 'OG000', 'lowerLimit': '52.3', 'upperLimit': '63.5'}, {'value': '63.6', 'groupId': 'OG001', 'lowerLimit': '58.1', 'upperLimit': '69.2'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '62.6', 'groupId': 'OG000', 'lowerLimit': '57.1', 'upperLimit': '68.1'}, {'value': '62.9', 'groupId': 'OG001', 'lowerLimit': '57.4', 'upperLimit': '68.4'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '61.9', 'groupId': 'OG000', 'lowerLimit': '56.3', 'upperLimit': '67.4'}, {'value': '65.4', 'groupId': 'OG001', 'lowerLimit': '59.9', 'upperLimit': '70.9'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '63.0', 'groupId': 'OG000', 'lowerLimit': '57.5', 'upperLimit': '68.4'}, {'value': '64.7', 'groupId': 'OG001', 'lowerLimit': '59.2', 'upperLimit': '70.2'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '62.3', 'groupId': 'OG000', 'lowerLimit': '56.7', 'upperLimit': '67.8'}, {'value': '66.9', 'groupId': 'OG001', 'lowerLimit': '61.5', 'upperLimit': '72.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '57.5', 'groupId': 'OG000', 'lowerLimit': '51.8', 'upperLimit': '63.3'}, {'value': '59.2', 'groupId': 'OG001', 'lowerLimit': '53.6', 'upperLimit': '64.9'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '69.1', 'groupId': 'OG000', 'lowerLimit': '63.8', 'upperLimit': '74.5'}, {'value': '69.0', 'groupId': 'OG001', 'lowerLimit': '63.6', 'upperLimit': '74.4'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '69.9', 'upperLimit': '80.1'}, {'value': '74.8', 'groupId': 'OG001', 'lowerLimit': '69.7', 'upperLimit': '79.8'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '72.1', 'groupId': 'OG000', 'lowerLimit': '66.9', 'upperLimit': '77.3'}, {'value': '76.6', 'groupId': 'OG001', 'lowerLimit': '71.6', 'upperLimit': '81.5'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '75.3', 'groupId': 'OG000', 'lowerLimit': '70.3', 'upperLimit': '80.4'}, {'value': '79.1', 'groupId': 'OG001', 'lowerLimit': '74.3', 'upperLimit': '83.9'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '77.5', 'groupId': 'OG000', 'lowerLimit': '72.6', 'upperLimit': '82.4'}, {'value': '77.3', 'groupId': 'OG001', 'lowerLimit': '72.4', 'upperLimit': '82.2'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '76.1', 'groupId': 'OG000', 'lowerLimit': '71.1', 'upperLimit': '81.1'}, {'value': '76.6', 'groupId': 'OG001', 'lowerLimit': '71.6', 'upperLimit': '81.5'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '77.5', 'groupId': 'OG000', 'lowerLimit': '72.6', 'upperLimit': '82.4'}, {'value': '78.4', 'groupId': 'OG001', 'lowerLimit': '73.6', 'upperLimit': '83.2'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '75.7', 'groupId': 'OG000', 'lowerLimit': '70.7', 'upperLimit': '80.7'}, {'value': '78.7', 'groupId': 'OG001', 'lowerLimit': '74.0', 'upperLimit': '83.5'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '77.5', 'groupId': 'OG000', 'lowerLimit': '72.7', 'upperLimit': '82.4'}, {'value': '76.2', 'groupId': 'OG001', 'lowerLimit': '71.3', 'upperLimit': '81.2'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '80.4', 'groupId': 'OG000', 'lowerLimit': '75.8', 'upperLimit': '85.1'}, {'value': '76.6', 'groupId': 'OG001', 'lowerLimit': '71.7', 'upperLimit': '81.5'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '79.7', 'groupId': 'OG000', 'lowerLimit': '75.0', 'upperLimit': '84.4'}, {'value': '79.4', 'groupId': 'OG001', 'lowerLimit': '74.7', 'upperLimit': '84.2'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '80.8', 'groupId': 'OG000', 'lowerLimit': '76.2', 'upperLimit': '85.4'}, {'value': '80.2', 'groupId': 'OG001', 'lowerLimit': '75.5', 'upperLimit': '84.8'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '75.7', 'groupId': 'OG000', 'lowerLimit': '70.7', 'upperLimit': '80.7'}, {'value': '78.0', 'groupId': 'OG001', 'lowerLimit': '73.2', 'upperLimit': '82.9'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '79.3', 'groupId': 'OG000', 'lowerLimit': '74.6', 'upperLimit': '84.0'}, {'value': '80.5', 'groupId': 'OG001', 'lowerLimit': '75.9', 'upperLimit': '85.2'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '78.9', 'groupId': 'OG000', 'lowerLimit': '74.2', 'upperLimit': '83.7'}, {'value': '78.7', 'groupId': 'OG001', 'lowerLimit': '73.9', 'upperLimit': '83.5'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '78.9', 'groupId': 'OG000', 'lowerLimit': '74.2', 'upperLimit': '83.7'}, {'value': '77.3', 'groupId': 'OG001', 'lowerLimit': '72.4', 'upperLimit': '82.2'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '80.4', 'groupId': 'OG000', 'lowerLimit': '75.8', 'upperLimit': '85.0'}, {'value': '79.5', 'groupId': 'OG001', 'lowerLimit': '74.7', 'upperLimit': '84.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '75.7', 'groupId': 'OG000', 'lowerLimit': '70.7', 'upperLimit': '80.7'}, {'value': '79.1', 'groupId': 'OG001', 'lowerLimit': '74.4', 'upperLimit': '83.9'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '84.0', 'groupId': 'OG000', 'lowerLimit': '79.7', 'upperLimit': '88.3'}, {'value': '88.1', 'groupId': 'OG001', 'lowerLimit': '84.3', 'upperLimit': '91.9'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '87.0', 'groupId': 'OG000', 'lowerLimit': '83.1', 'upperLimit': '90.9'}, {'value': '87.0', 'groupId': 'OG001', 'lowerLimit': '83.1', 'upperLimit': '91.0'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '85.9', 'groupId': 'OG000', 'lowerLimit': '81.8', 'upperLimit': '89.9'}, {'value': '88.8', 'groupId': 'OG001', 'lowerLimit': '85.1', 'upperLimit': '92.5'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000', 'lowerLimit': '84.6', 'upperLimit': '92.2'}, {'value': '90.3', 'groupId': 'OG001', 'lowerLimit': '86.8', 'upperLimit': '93.7'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000', 'lowerLimit': '87.6', 'upperLimit': '94.3'}, {'value': '89.6', 'groupId': 'OG001', 'lowerLimit': '86.0', 'upperLimit': '93.1'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '89.1', 'groupId': 'OG000', 'lowerLimit': '85.5', 'upperLimit': '92.8'}, {'value': '87.8', 'groupId': 'OG001', 'lowerLimit': '84.0', 'upperLimit': '91.6'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000', 'lowerLimit': '85.9', 'upperLimit': '93.1'}, {'value': '87.7', 'groupId': 'OG001', 'lowerLimit': '83.9', 'upperLimit': '91.6'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000', 'lowerLimit': '84.6', 'upperLimit': '92.1'}, {'value': '90.6', 'groupId': 'OG001', 'lowerLimit': '87.2', 'upperLimit': '94.0'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '90.2', 'groupId': 'OG000', 'lowerLimit': '86.7', 'upperLimit': '93.7'}, {'value': '90.6', 'groupId': 'OG001', 'lowerLimit': '87.2', 'upperLimit': '94.0'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '89.1', 'groupId': 'OG000', 'lowerLimit': '85.5', 'upperLimit': '92.8'}, {'value': '88.4', 'groupId': 'OG001', 'lowerLimit': '84.7', 'upperLimit': '92.2'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000', 'lowerLimit': '84.6', 'upperLimit': '92.2'}, {'value': '90.3', 'groupId': 'OG001', 'lowerLimit': '86.8', 'upperLimit': '93.8'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '89.9', 'groupId': 'OG000', 'lowerLimit': '86.4', 'upperLimit': '93.4'}, {'value': '88.5', 'groupId': 'OG001', 'lowerLimit': '84.7', 'upperLimit': '92.2'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000', 'lowerLimit': '84.3', 'upperLimit': '91.8'}, {'value': '87.0', 'groupId': 'OG001', 'lowerLimit': '83.1', 'upperLimit': '91.0'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '89.9', 'groupId': 'OG000', 'lowerLimit': '86.3', 'upperLimit': '93.4'}, {'value': '88.1', 'groupId': 'OG001', 'lowerLimit': '84.3', 'upperLimit': '91.9'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '90.6', 'groupId': 'OG000', 'lowerLimit': '87.1', 'upperLimit': '94.0'}, {'value': '87.7', 'groupId': 'OG001', 'lowerLimit': '83.9', 'upperLimit': '91.6'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000', 'lowerLimit': '85.9', 'upperLimit': '93.1'}, {'value': '87.1', 'groupId': 'OG001', 'lowerLimit': '83.1', 'upperLimit': '91.0'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '89.8', 'groupId': 'OG000', 'lowerLimit': '86.3', 'upperLimit': '93.4'}, {'value': '87.4', 'groupId': 'OG001', 'lowerLimit': '83.5', 'upperLimit': '91.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '90.2', 'groupId': 'OG000', 'lowerLimit': '86.8', 'upperLimit': '93.6'}, {'value': '93.2', 'groupId': 'OG001', 'lowerLimit': '90.3', 'upperLimit': '96.1'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '92.7', 'groupId': 'OG000', 'lowerLimit': '89.7', 'upperLimit': '95.8'}, {'value': '96.8', 'groupId': 'OG001', 'lowerLimit': '94.7', 'upperLimit': '98.8'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000', 'lowerLimit': '92.4', 'upperLimit': '97.5'}, {'value': '94.2', 'groupId': 'OG001', 'lowerLimit': '91.5', 'upperLimit': '97.0'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '93.8', 'groupId': 'OG000', 'lowerLimit': '91.1', 'upperLimit': '96.6'}, {'value': '94.9', 'groupId': 'OG001', 'lowerLimit': '92.4', 'upperLimit': '97.5'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000', 'lowerLimit': '92.4', 'upperLimit': '97.5'}, {'value': '96.0', 'groupId': 'OG001', 'lowerLimit': '93.8', 'upperLimit': '98.3'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '94.2', 'upperLimit': '98.6'}, {'value': '95.3', 'groupId': 'OG001', 'lowerLimit': '92.9', 'upperLimit': '97.8'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000', 'lowerLimit': '92.9', 'upperLimit': '97.8'}, {'value': '95.0', 'groupId': 'OG001', 'lowerLimit': '92.4', 'upperLimit': '97.5'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000', 'lowerLimit': '93.8', 'upperLimit': '98.3'}, {'value': '95.0', 'groupId': 'OG001', 'lowerLimit': '92.4', 'upperLimit': '97.5'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '94.2', 'groupId': 'OG000', 'lowerLimit': '91.5', 'upperLimit': '96.9'}, {'value': '94.6', 'groupId': 'OG001', 'lowerLimit': '92.0', 'upperLimit': '97.2'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '94.6', 'groupId': 'OG000', 'lowerLimit': '91.9', 'upperLimit': '97.2'}, {'value': '95.7', 'groupId': 'OG001', 'lowerLimit': '93.3', 'upperLimit': '98.0'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000', 'lowerLimit': '92.9', 'upperLimit': '97.7'}, {'value': '94.6', 'groupId': 'OG001', 'lowerLimit': '92.0', 'upperLimit': '97.2'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '94.6', 'groupId': 'OG000', 'lowerLimit': '92.0', 'upperLimit': '97.2'}, {'value': '96.1', 'groupId': 'OG001', 'lowerLimit': '93.8', 'upperLimit': '98.3'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '93.8', 'groupId': 'OG000', 'lowerLimit': '91.1', 'upperLimit': '96.6'}, {'value': '94.6', 'groupId': 'OG001', 'lowerLimit': '92.1', 'upperLimit': '97.2'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '93.1', 'groupId': 'OG000', 'lowerLimit': '90.2', 'upperLimit': '96.1'}, {'value': '95.3', 'groupId': 'OG001', 'lowerLimit': '92.9', 'upperLimit': '97.8'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '94.6', 'groupId': 'OG000', 'lowerLimit': '91.9', 'upperLimit': '97.2'}, {'value': '94.2', 'groupId': 'OG001', 'lowerLimit': '91.5', 'upperLimit': '97.0'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000', 'lowerLimit': '92.4', 'upperLimit': '97.5'}, {'value': '94.2', 'groupId': 'OG001', 'lowerLimit': '91.5', 'upperLimit': '97.0'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '93.5', 'groupId': 'OG000', 'lowerLimit': '90.6', 'upperLimit': '96.4'}, {'value': '93.9', 'groupId': 'OG001', 'lowerLimit': '91.1', 'upperLimit': '96.7'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '94.6', 'groupId': 'OG000', 'lowerLimit': '91.9', 'upperLimit': '97.2'}, {'value': '93.9', 'groupId': 'OG001', 'lowerLimit': '91.1', 'upperLimit': '96.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '98.3', 'upperLimit': '100.0'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '98.3', 'upperLimit': '100.0'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '98.3', 'upperLimit': '100.0'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '98.3', 'upperLimit': '100.0'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '99.9'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '98.9', 'upperLimit': '100.0'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '99.9'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '98.9', 'upperLimit': '100.0'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '99.9'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '98.9', 'upperLimit': '100.0'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '99.9'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '98.9', 'upperLimit': '100.0'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '99.9'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '98.9', 'upperLimit': '100.0'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '100.0'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '100.0'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '98.3', 'upperLimit': '100.0'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '100.0'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '98.3', 'upperLimit': '100.0'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '96.7', 'upperLimit': '99.8'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100.0'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '96.7', 'upperLimit': '99.8'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '96.7', 'upperLimit': '99.8'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '98.3', 'upperLimit': '100.0'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '96.7', 'upperLimit': '99.8'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '97.9', 'groupId': 'OG001', 'lowerLimit': '96.2', 'upperLimit': '99.5'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '96.7', 'upperLimit': '99.8'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '96.7', 'upperLimit': '99.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '97.1', 'upperLimit': '99.9'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '97.1', 'upperLimit': '100.0'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '97.1', 'upperLimit': '99.9'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '97.1', 'upperLimit': '99.9'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '96.7', 'upperLimit': '99.7'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '98.3', 'upperLimit': '100.0'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '99.9'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '98.9', 'upperLimit': '100.0'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '96.7', 'upperLimit': '99.7'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '98.9', 'upperLimit': '100.0'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '96.7', 'upperLimit': '99.7'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '98.3', 'upperLimit': '100.0'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '96.7', 'upperLimit': '99.7'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '98.9', 'upperLimit': '100.0'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '100.0'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '100.0'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '98.3', 'upperLimit': '100.0'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '96.7', 'upperLimit': '99.8'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '96.7', 'upperLimit': '99.8'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100.0'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '96.7', 'upperLimit': '99.8'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '97.9', 'groupId': 'OG001', 'lowerLimit': '96.2', 'upperLimit': '99.5'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100.0'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '96.7', 'upperLimit': '99.8'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '99.9'}, {'value': '97.1', 'groupId': 'OG001', 'lowerLimit': '95.2', 'upperLimit': '99.1'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100.0'}, {'value': '97.9', 'groupId': 'OG001', 'lowerLimit': '96.2', 'upperLimit': '99.5'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '99.8'}, {'value': '97.9', 'groupId': 'OG001', 'lowerLimit': '96.2', 'upperLimit': '99.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '95.1', 'upperLimit': '99.1'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '99.9'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000', 'lowerLimit': '96.1', 'upperLimit': '99.5'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '97.2', 'upperLimit': '99.9'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000', 'lowerLimit': '96.1', 'upperLimit': '99.5'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000', 'lowerLimit': '96.1', 'upperLimit': '99.5'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '96.7', 'upperLimit': '99.7'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '97.1', 'upperLimit': '99.9'}, {'value': '97.8', 'groupId': 'OG001', 'lowerLimit': '96.2', 'upperLimit': '99.5'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '100.0'}, {'value': '97.5', 'groupId': 'OG001', 'lowerLimit': '95.7', 'upperLimit': '99.3'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '99.8'}, {'value': '97.5', 'groupId': 'OG001', 'lowerLimit': '95.7', 'upperLimit': '99.3'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '99.9'}, {'value': '97.8', 'groupId': 'OG001', 'lowerLimit': '96.2', 'upperLimit': '99.5'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '96.7', 'upperLimit': '99.7'}, {'value': '97.5', 'groupId': 'OG001', 'lowerLimit': '95.7', 'upperLimit': '99.3'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '95.2', 'upperLimit': '99.0'}, {'value': '97.5', 'groupId': 'OG001', 'lowerLimit': '95.6', 'upperLimit': '99.3'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '99.9'}, {'value': '97.8', 'groupId': 'OG001', 'lowerLimit': '96.1', 'upperLimit': '99.5'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '95.2', 'upperLimit': '99.0'}, {'value': '97.9', 'groupId': 'OG001', 'lowerLimit': '96.2', 'upperLimit': '99.5'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '95.2', 'upperLimit': '99.1'}, {'value': '97.5', 'groupId': 'OG001', 'lowerLimit': '95.7', 'upperLimit': '99.3'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000', 'lowerLimit': '95.6', 'upperLimit': '99.3'}, {'value': '97.5', 'groupId': 'OG001', 'lowerLimit': '95.7', 'upperLimit': '99.3'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000', 'lowerLimit': '96.1', 'upperLimit': '99.5'}, {'value': '96.8', 'groupId': 'OG001', 'lowerLimit': '94.7', 'upperLimit': '98.8'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '95.1', 'upperLimit': '99.1'}, {'value': '96.8', 'groupId': 'OG001', 'lowerLimit': '94.7', 'upperLimit': '98.8'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '95.1', 'upperLimit': '99.1'}, {'value': '97.1', 'groupId': 'OG001', 'lowerLimit': '95.2', 'upperLimit': '99.1'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '95.1', 'upperLimit': '99.1'}, {'value': '96.8', 'groupId': 'OG001', 'lowerLimit': '94.7', 'upperLimit': '98.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '11.9'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '11.8'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000', 'lowerLimit': '10.3', 'upperLimit': '18.0'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '11.5', 'upperLimit': '19.5'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000', 'lowerLimit': '11.7', 'upperLimit': '19.6'}, {'value': '20.2', 'groupId': 'OG001', 'lowerLimit': '15.7', 'upperLimit': '24.6'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000', 'lowerLimit': '13.3', 'upperLimit': '21.6'}, {'value': '22.0', 'groupId': 'OG001', 'lowerLimit': '17.4', 'upperLimit': '26.5'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '20.7', 'groupId': 'OG000', 'lowerLimit': '16.2', 'upperLimit': '25.2'}, {'value': '23.8', 'groupId': 'OG001', 'lowerLimit': '19.0', 'upperLimit': '28.5'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '22.9', 'groupId': 'OG000', 'lowerLimit': '18.2', 'upperLimit': '27.6'}, {'value': '23.8', 'groupId': 'OG001', 'lowerLimit': '19.1', 'upperLimit': '28.5'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000', 'lowerLimit': '19.2', 'upperLimit': '28.8'}, {'value': '25.6', 'groupId': 'OG001', 'lowerLimit': '20.7', 'upperLimit': '30.4'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '25.1', 'groupId': 'OG000', 'lowerLimit': '20.3', 'upperLimit': '29.8'}, {'value': '23.4', 'groupId': 'OG001', 'lowerLimit': '18.8', 'upperLimit': '28.0'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '25.1', 'groupId': 'OG000', 'lowerLimit': '20.2', 'upperLimit': '29.9'}, {'value': '25.2', 'groupId': 'OG001', 'lowerLimit': '20.4', 'upperLimit': '30.0'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000', 'lowerLimit': '22.0', 'upperLimit': '31.8'}, {'value': '22.0', 'groupId': 'OG001', 'lowerLimit': '17.4', 'upperLimit': '26.5'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '26.8', 'groupId': 'OG000', 'lowerLimit': '21.8', 'upperLimit': '31.8'}, {'value': '24.8', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '29.7'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000', 'lowerLimit': '24.0', 'upperLimit': '34.1'}, {'value': '25.2', 'groupId': 'OG001', 'lowerLimit': '20.3', 'upperLimit': '30.1'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '26.8', 'groupId': 'OG000', 'lowerLimit': '21.9', 'upperLimit': '31.7'}, {'value': '25.6', 'groupId': 'OG001', 'lowerLimit': '20.7', 'upperLimit': '30.4'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000', 'lowerLimit': '21.2', 'upperLimit': '31.0'}, {'value': '22.0', 'groupId': 'OG001', 'lowerLimit': '17.3', 'upperLimit': '26.6'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '27.6', 'groupId': 'OG000', 'lowerLimit': '22.6', 'upperLimit': '32.6'}, {'value': '25.6', 'groupId': 'OG001', 'lowerLimit': '20.8', 'upperLimit': '30.4'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '30.1', 'groupId': 'OG000', 'lowerLimit': '25.0', 'upperLimit': '35.3'}, {'value': '24.5', 'groupId': 'OG001', 'lowerLimit': '19.7', 'upperLimit': '29.3'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000', 'lowerLimit': '24.2', 'upperLimit': '34.6'}, {'value': '25.9', 'groupId': 'OG001', 'lowerLimit': '21.0', 'upperLimit': '30.8'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000', 'lowerLimit': '24.3', 'upperLimit': '34.5'}, {'value': '24.8', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '29.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '50.6', 'upperLimit': '60.5'}, {'value': '62.3', 'groupId': 'OG001', 'lowerLimit': '57.3', 'upperLimit': '67.3'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '63.9', 'groupId': 'OG000', 'lowerLimit': '59.3', 'upperLimit': '68.6'}, {'value': '70.3', 'groupId': 'OG001', 'lowerLimit': '65.7', 'upperLimit': '74.9'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000', 'lowerLimit': '64.4', 'upperLimit': '73.6'}, {'value': '69.2', 'groupId': 'OG001', 'lowerLimit': '64.4', 'upperLimit': '74.0'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '72.2', 'groupId': 'OG000', 'lowerLimit': '67.7', 'upperLimit': '76.8'}, {'value': '72.1', 'groupId': 'OG001', 'lowerLimit': '67.5', 'upperLimit': '76.8'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000', 'lowerLimit': '69.1', 'upperLimit': '77.6'}, {'value': '76.1', 'groupId': 'OG001', 'lowerLimit': '71.7', 'upperLimit': '80.5'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '73.7', 'groupId': 'OG000', 'lowerLimit': '69.3', 'upperLimit': '78.1'}, {'value': '76.5', 'groupId': 'OG001', 'lowerLimit': '71.9', 'upperLimit': '81.0'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000', 'lowerLimit': '68.7', 'upperLimit': '77.9'}, {'value': '75.4', 'groupId': 'OG001', 'lowerLimit': '70.7', 'upperLimit': '80.0'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000', 'lowerLimit': '72.6', 'upperLimit': '81.2'}, {'value': '75.4', 'groupId': 'OG001', 'lowerLimit': '70.7', 'upperLimit': '80.1'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '76.2', 'groupId': 'OG000', 'lowerLimit': '71.8', 'upperLimit': '80.6'}, {'value': '77.9', 'groupId': 'OG001', 'lowerLimit': '73.3', 'upperLimit': '82.5'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '75.5', 'groupId': 'OG000', 'lowerLimit': '71.0', 'upperLimit': '79.9'}, {'value': '76.8', 'groupId': 'OG001', 'lowerLimit': '72.3', 'upperLimit': '81.3'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000', 'lowerLimit': '72.4', 'upperLimit': '81.4'}, {'value': '76.1', 'groupId': 'OG001', 'lowerLimit': '71.4', 'upperLimit': '80.7'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '77.2', 'groupId': 'OG000', 'lowerLimit': '72.7', 'upperLimit': '81.8'}, {'value': '79.3', 'groupId': 'OG001', 'lowerLimit': '75.0', 'upperLimit': '83.7'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '78.7', 'groupId': 'OG000', 'lowerLimit': '74.3', 'upperLimit': '83.1'}, {'value': '80.4', 'groupId': 'OG001', 'lowerLimit': '76.1', 'upperLimit': '84.7'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '76.2', 'groupId': 'OG000', 'lowerLimit': '71.5', 'upperLimit': '80.9'}, {'value': '79.0', 'groupId': 'OG001', 'lowerLimit': '74.5', 'upperLimit': '83.5'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '80.2', 'groupId': 'OG000', 'lowerLimit': '75.8', 'upperLimit': '84.5'}, {'value': '79.0', 'groupId': 'OG001', 'lowerLimit': '74.5', 'upperLimit': '83.5'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '77.6', 'groupId': 'OG000', 'lowerLimit': '73.0', 'upperLimit': '82.2'}, {'value': '81.1', 'groupId': 'OG001', 'lowerLimit': '76.8', 'upperLimit': '85.5'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '77.6', 'groupId': 'OG000', 'lowerLimit': '73.0', 'upperLimit': '82.2'}, {'value': '80.4', 'groupId': 'OG001', 'lowerLimit': '76.0', 'upperLimit': '84.9'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '78.0', 'groupId': 'OG000', 'lowerLimit': '73.5', 'upperLimit': '82.4'}, {'value': '79.0', 'groupId': 'OG001', 'lowerLimit': '74.4', 'upperLimit': '83.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '5.3'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '2.9'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '5.0'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '3.3'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '3.8'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '2.8'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '3.8'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '3.3'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '3.8'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '3.3'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '3.8'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '3.3'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '3.5'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '3.3'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '4.0'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '3.3'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '3.4'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '2.8'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '3.7'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '2.8'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.4'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '2.8'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '4.0'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '3.9'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '4.9'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '4.3'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.4'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '4.3'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '3.6'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '4.3'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '4.9'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '3.9'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '3.6'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '3.3'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '3.6'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '3.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (\\>38 and ≤38 letters) and region (U.S. and Canada, Asia, and rest of the world). All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Parts 1 and 2: Change From Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '6.6'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '7.0'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '7.5'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '7.4'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '7.3'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '9.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 24, 48, and 72', 'description': "The NEI VFQ-25 captures a patient's perception of vision-related functioning and vision-related quality of life. The core measure includes 25 items that comprise 11 vision-related subscales and 1 item on general health. The composite score ranges from 0 to 100, with higher scores indicating better vision-related functioning. For the MMRM analysis, the model adjusted for the treatment group, visit, visit-by-treatment group interaction, baseline NEI VFQ-25 Composite Score continuous), baseline BCVA score (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and the rest of the world). Observed NEI VFQ-25 assessments were used regardless of the occurrence of intercurrent events. Missing data were implicitly imputed. Invalid BCVA values were excluded. 95% CI is a rounding of 95.03% CI.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-287.3', 'groupId': 'OG000', 'lowerLimit': '-293.5', 'upperLimit': '-281.1'}, {'value': '-284.3', 'groupId': 'OG001', 'lowerLimit': '-290.4', 'upperLimit': '-278.2'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-302.9', 'groupId': 'OG000', 'lowerLimit': '-308.7', 'upperLimit': '-297.2'}, {'value': '-300.2', 'groupId': 'OG001', 'lowerLimit': '-306.0', 'upperLimit': '-294.5'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-307.8', 'groupId': 'OG000', 'lowerLimit': '-313.1', 'upperLimit': '-302.6'}, {'value': '-301.9', 'groupId': 'OG001', 'lowerLimit': '-307.1', 'upperLimit': '-296.7'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-309.3', 'groupId': 'OG000', 'lowerLimit': '-314.6', 'upperLimit': '-304.0'}, {'value': '-304.5', 'groupId': 'OG001', 'lowerLimit': '-309.8', 'upperLimit': '-299.3'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '-310.6', 'groupId': 'OG000', 'lowerLimit': '-315.5', 'upperLimit': '-305.6'}, {'value': '-304.2', 'groupId': 'OG001', 'lowerLimit': '-309.1', 'upperLimit': '-299.3'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-314.5', 'groupId': 'OG000', 'lowerLimit': '-319.5', 'upperLimit': '-309.6'}, {'value': '-307.6', 'groupId': 'OG001', 'lowerLimit': '-312.5', 'upperLimit': '-302.7'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '-294.0', 'groupId': 'OG000', 'lowerLimit': '-302.2', 'upperLimit': '-285.8'}, {'value': '-285.1', 'groupId': 'OG001', 'lowerLimit': '-293.3', 'upperLimit': '-276.9'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '-308.3', 'groupId': 'OG000', 'lowerLimit': '-314.6', 'upperLimit': '-302.0'}, {'value': '-303.2', 'groupId': 'OG001', 'lowerLimit': '-309.4', 'upperLimit': '-297.0'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '-304.1', 'groupId': 'OG000', 'lowerLimit': '-310.6', 'upperLimit': '-297.6'}, {'value': '-298.8', 'groupId': 'OG001', 'lowerLimit': '-305.2', 'upperLimit': '-292.4'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '-296.7', 'groupId': 'OG000', 'lowerLimit': '-304.4', 'upperLimit': '-288.9'}, {'value': '-285.8', 'groupId': 'OG001', 'lowerLimit': '-293.7', 'upperLimit': '-278.0'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '-309.2', 'groupId': 'OG000', 'lowerLimit': '-315.9', 'upperLimit': '-302.5'}, {'value': '-301.6', 'groupId': 'OG001', 'lowerLimit': '-308.3', 'upperLimit': '-294.9'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '-309.4', 'groupId': 'OG000', 'lowerLimit': '-315.3', 'upperLimit': '-303.5'}, {'value': '-302.8', 'groupId': 'OG001', 'lowerLimit': '-308.7', 'upperLimit': '-296.9'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '-302.2', 'groupId': 'OG000', 'lowerLimit': '-308.6', 'upperLimit': '-295.7'}, {'value': '-302.4', 'groupId': 'OG001', 'lowerLimit': '-308.8', 'upperLimit': '-296.0'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '-294.0', 'groupId': 'OG000', 'lowerLimit': '-302.6', 'upperLimit': '-285.5'}, {'value': '-288.0', 'groupId': 'OG001', 'lowerLimit': '-296.6', 'upperLimit': '-279.4'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '-309.5', 'groupId': 'OG000', 'lowerLimit': '-315.1', 'upperLimit': '-303.9'}, {'value': '-306.2', 'groupId': 'OG001', 'lowerLimit': '-311.9', 'upperLimit': '-300.6'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '-311.1', 'groupId': 'OG000', 'lowerLimit': '-316.3', 'upperLimit': '-305.9'}, {'value': '-305.9', 'groupId': 'OG001', 'lowerLimit': '-311.1', 'upperLimit': '-300.7'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '-311.2', 'groupId': 'OG000', 'lowerLimit': '-316.3', 'upperLimit': '-306.1'}, {'value': '-307.9', 'groupId': 'OG001', 'lowerLimit': '-313.0', 'upperLimit': '-302.8'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '-310.5', 'groupId': 'OG000', 'lowerLimit': '-315.7', 'upperLimit': '-305.4'}, {'value': '-307.2', 'groupId': 'OG001', 'lowerLimit': '-312.3', 'upperLimit': '-302.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline CST (continuous), and randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'microns', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '88.8', 'groupId': 'OG000', 'lowerLimit': '85.1', 'upperLimit': '92.5'}, {'value': '88.1', 'groupId': 'OG001', 'lowerLimit': '84.4', 'upperLimit': '91.9'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '94.5', 'groupId': 'OG000', 'lowerLimit': '91.9', 'upperLimit': '97.2'}, {'value': '93.2', 'groupId': 'OG001', 'lowerLimit': '90.3', 'upperLimit': '96.1'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '94.2', 'upperLimit': '98.5'}, {'value': '92.1', 'groupId': 'OG001', 'lowerLimit': '89.0', 'upperLimit': '95.2'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000', 'lowerLimit': '92.8', 'upperLimit': '97.7'}, {'value': '93.6', 'groupId': 'OG001', 'lowerLimit': '90.7', 'upperLimit': '96.4'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000', 'lowerLimit': '93.7', 'upperLimit': '98.3'}, {'value': '94.6', 'groupId': 'OG001', 'lowerLimit': '92.1', 'upperLimit': '97.2'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '95.6', 'groupId': 'OG000', 'lowerLimit': '93.3', 'upperLimit': '98.0'}, {'value': '94.3', 'groupId': 'OG001', 'lowerLimit': '91.6', 'upperLimit': '96.9'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '89.1', 'groupId': 'OG000', 'lowerLimit': '85.5', 'upperLimit': '92.8'}, {'value': '86.0', 'groupId': 'OG001', 'lowerLimit': '82.0', 'upperLimit': '90.0'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '94.6', 'groupId': 'OG000', 'lowerLimit': '91.9', 'upperLimit': '97.2'}, {'value': '92.5', 'groupId': 'OG001', 'lowerLimit': '89.4', 'upperLimit': '95.5'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '93.8', 'groupId': 'OG000', 'lowerLimit': '91.1', 'upperLimit': '96.5'}, {'value': '90.7', 'groupId': 'OG001', 'lowerLimit': '87.3', 'upperLimit': '94.0'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000', 'lowerLimit': '85.9', 'upperLimit': '93.0'}, {'value': '84.2', 'groupId': 'OG001', 'lowerLimit': '79.9', 'upperLimit': '88.4'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000', 'lowerLimit': '93.7', 'upperLimit': '98.3'}, {'value': '92.1', 'groupId': 'OG001', 'lowerLimit': '88.9', 'upperLimit': '95.2'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000', 'lowerLimit': '92.4', 'upperLimit': '97.5'}, {'value': '91.4', 'groupId': 'OG001', 'lowerLimit': '88.1', 'upperLimit': '94.6'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '92.4', 'groupId': 'OG000', 'lowerLimit': '89.3', 'upperLimit': '95.5'}, {'value': '91.4', 'groupId': 'OG001', 'lowerLimit': '88.2', 'upperLimit': '94.6'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000', 'lowerLimit': '85.9', 'upperLimit': '93.1'}, {'value': '86.3', 'groupId': 'OG001', 'lowerLimit': '82.3', 'upperLimit': '90.3'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '94.2', 'groupId': 'OG000', 'lowerLimit': '91.5', 'upperLimit': '96.9'}, {'value': '93.9', 'groupId': 'OG001', 'lowerLimit': '91.1', 'upperLimit': '96.7'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000', 'lowerLimit': '92.8', 'upperLimit': '97.8'}, {'value': '93.9', 'groupId': 'OG001', 'lowerLimit': '91.1', 'upperLimit': '96.7'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000', 'lowerLimit': '92.4', 'upperLimit': '97.5'}, {'value': '92.4', 'groupId': 'OG001', 'lowerLimit': '89.4', 'upperLimit': '95.5'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '94.2', 'groupId': 'OG000', 'lowerLimit': '91.5', 'upperLimit': '96.9'}, {'value': '94.2', 'groupId': 'OG001', 'lowerLimit': '91.5', 'upperLimit': '97.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': "Absence of diabetic macular edema was defined as achieving a central subfield thickness of \\<325 microns in the study eye. Central subfield thickness was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '46.1', 'groupId': 'OG000', 'lowerLimit': '40.2', 'upperLimit': '51.9'}, {'value': '54.8', 'groupId': 'OG001', 'lowerLimit': '49.0', 'upperLimit': '60.6'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000', 'lowerLimit': '48.2', 'upperLimit': '59.4'}, {'value': '57.4', 'groupId': 'OG001', 'lowerLimit': '51.6', 'upperLimit': '63.1'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '65.3', 'groupId': 'OG000', 'lowerLimit': '59.7', 'upperLimit': '70.8'}, {'value': '56.6', 'groupId': 'OG001', 'lowerLimit': '50.8', 'upperLimit': '62.4'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '69.9', 'groupId': 'OG000', 'lowerLimit': '64.6', 'upperLimit': '75.3'}, {'value': '72.9', 'groupId': 'OG001', 'lowerLimit': '67.8', 'upperLimit': '78.1'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '67.1', 'groupId': 'OG000', 'lowerLimit': '61.6', 'upperLimit': '72.6'}, {'value': '66.4', 'groupId': 'OG001', 'lowerLimit': '60.9', 'upperLimit': '71.9'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '73.9', 'groupId': 'OG000', 'lowerLimit': '68.9', 'upperLimit': '79.0'}, {'value': '69.3', 'groupId': 'OG001', 'lowerLimit': '63.9', 'upperLimit': '74.7'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '54.4', 'groupId': 'OG000', 'lowerLimit': '48.7', 'upperLimit': '60.2'}, {'value': '47.6', 'groupId': 'OG001', 'lowerLimit': '41.8', 'upperLimit': '53.5'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '68.1', 'groupId': 'OG000', 'lowerLimit': '62.6', 'upperLimit': '73.6'}, {'value': '65.0', 'groupId': 'OG001', 'lowerLimit': '59.4', 'upperLimit': '70.6'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '60.9', 'groupId': 'OG000', 'lowerLimit': '55.1', 'upperLimit': '66.6'}, {'value': '56.0', 'groupId': 'OG001', 'lowerLimit': '50.2', 'upperLimit': '61.7'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '50.8', 'groupId': 'OG000', 'lowerLimit': '45.0', 'upperLimit': '56.6'}, {'value': '48.1', 'groupId': 'OG001', 'lowerLimit': '42.3', 'upperLimit': '53.9'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '70.3', 'groupId': 'OG000', 'lowerLimit': '64.9', 'upperLimit': '75.6'}, {'value': '63.9', 'groupId': 'OG001', 'lowerLimit': '58.3', 'upperLimit': '69.6'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '76.1', 'groupId': 'OG000', 'lowerLimit': '71.1', 'upperLimit': '81.1'}, {'value': '67.9', 'groupId': 'OG001', 'lowerLimit': '62.5', 'upperLimit': '73.3'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '55.8', 'groupId': 'OG000', 'lowerLimit': '50.0', 'upperLimit': '61.7'}, {'value': '56.7', 'groupId': 'OG001', 'lowerLimit': '50.9', 'upperLimit': '62.5'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '58.4', 'groupId': 'OG000', 'lowerLimit': '52.6', 'upperLimit': '64.1'}, {'value': '58.9', 'groupId': 'OG001', 'lowerLimit': '53.2', 'upperLimit': '64.6'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '69.9', 'upperLimit': '80.1'}, {'value': '72.6', 'groupId': 'OG001', 'lowerLimit': '67.4', 'upperLimit': '77.7'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '75.8', 'groupId': 'OG000', 'lowerLimit': '70.9', 'upperLimit': '80.7'}, {'value': '69.7', 'groupId': 'OG001', 'lowerLimit': '64.3', 'upperLimit': '75.1'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '69.9', 'groupId': 'OG000', 'lowerLimit': '64.5', 'upperLimit': '75.3'}, {'value': '68.6', 'groupId': 'OG001', 'lowerLimit': '63.2', 'upperLimit': '74.1'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '72.8', 'groupId': 'OG000', 'lowerLimit': '67.6', 'upperLimit': '78.0'}, {'value': '72.9', 'groupId': 'OG001', 'lowerLimit': '67.7', 'upperLimit': '78.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Intraretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '76.1', 'groupId': 'OG000', 'lowerLimit': '71.1', 'upperLimit': '81.1'}, {'value': '72.9', 'groupId': 'OG001', 'lowerLimit': '67.8', 'upperLimit': '78.1'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '93.1', 'groupId': 'OG000', 'lowerLimit': '90.2', 'upperLimit': '96.1'}, {'value': '91.4', 'groupId': 'OG001', 'lowerLimit': '88.1', 'upperLimit': '94.6'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '94.2', 'upperLimit': '98.6'}, {'value': '97.1', 'groupId': 'OG001', 'lowerLimit': '95.2', 'upperLimit': '99.1'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000', 'lowerLimit': '92.8', 'upperLimit': '97.8'}, {'value': '96.4', 'groupId': 'OG001', 'lowerLimit': '94.2', 'upperLimit': '98.6'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '99.8'}, {'value': '97.8', 'groupId': 'OG001', 'lowerLimit': '96.1', 'upperLimit': '99.5'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '91.3', 'groupId': 'OG000', 'lowerLimit': '88.0', 'upperLimit': '94.6'}, {'value': '90.3', 'groupId': 'OG001', 'lowerLimit': '86.9', 'upperLimit': '93.7'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '93.5', 'groupId': 'OG000', 'lowerLimit': '90.7', 'upperLimit': '96.4'}, {'value': '91.0', 'groupId': 'OG001', 'lowerLimit': '87.6', 'upperLimit': '94.3'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '94.2', 'upperLimit': '98.6'}, {'value': '97.1', 'groupId': 'OG001', 'lowerLimit': '95.2', 'upperLimit': '99.1'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '95.1', 'upperLimit': '99.1'}, {'value': '96.0', 'groupId': 'OG001', 'lowerLimit': '93.7', 'upperLimit': '98.3'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '96.8', 'groupId': 'OG000', 'lowerLimit': '94.7', 'upperLimit': '98.8'}, {'value': '95.7', 'groupId': 'OG001', 'lowerLimit': '93.3', 'upperLimit': '98.1'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000', 'lowerLimit': '95.7', 'upperLimit': '99.3'}, {'value': '95.7', 'groupId': 'OG001', 'lowerLimit': '93.3', 'upperLimit': '98.0'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '95.1', 'upperLimit': '99.1'}, {'value': '94.6', 'groupId': 'OG001', 'lowerLimit': '91.9', 'upperLimit': '97.2'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '99.8'}, {'value': '97.1', 'groupId': 'OG001', 'lowerLimit': '95.2', 'upperLimit': '99.1'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000', 'lowerLimit': '92.8', 'upperLimit': '97.8'}, {'value': '95.0', 'groupId': 'OG001', 'lowerLimit': '92.4', 'upperLimit': '97.5'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000', 'lowerLimit': '93.3', 'upperLimit': '98.1'}, {'value': '96.0', 'groupId': 'OG001', 'lowerLimit': '93.8', 'upperLimit': '98.3'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '96.7', 'upperLimit': '99.7'}, {'value': '96.8', 'groupId': 'OG001', 'lowerLimit': '94.7', 'upperLimit': '98.8'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000', 'lowerLimit': '95.6', 'upperLimit': '99.3'}, {'value': '97.5', 'groupId': 'OG001', 'lowerLimit': '95.7', 'upperLimit': '99.3'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '94.2', 'upperLimit': '98.6'}, {'value': '94.9', 'groupId': 'OG001', 'lowerLimit': '92.4', 'upperLimit': '97.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Subretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '37.8', 'groupId': 'OG000', 'lowerLimit': '32.1', 'upperLimit': '43.4'}, {'value': '40.8', 'groupId': 'OG001', 'lowerLimit': '35.2', 'upperLimit': '46.4'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '50.9', 'groupId': 'OG000', 'lowerLimit': '45.3', 'upperLimit': '56.5'}, {'value': '54.1', 'groupId': 'OG001', 'lowerLimit': '48.4', 'upperLimit': '59.9'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '63.8', 'groupId': 'OG000', 'lowerLimit': '58.2', 'upperLimit': '69.4'}, {'value': '56.3', 'groupId': 'OG001', 'lowerLimit': '50.5', 'upperLimit': '62.1'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '67.1', 'groupId': 'OG000', 'lowerLimit': '61.6', 'upperLimit': '72.6'}, {'value': '72.6', 'groupId': 'OG001', 'lowerLimit': '67.4', 'upperLimit': '77.8'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '66.0', 'groupId': 'OG000', 'lowerLimit': '60.5', 'upperLimit': '71.5'}, {'value': '66.0', 'groupId': 'OG001', 'lowerLimit': '60.5', 'upperLimit': '71.6'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '67.4', 'groupId': 'OG000', 'lowerLimit': '61.9', 'upperLimit': '72.9'}, {'value': '64.3', 'groupId': 'OG001', 'lowerLimit': '58.6', 'upperLimit': '69.9'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '53.0', 'groupId': 'OG000', 'lowerLimit': '47.2', 'upperLimit': '58.7'}, {'value': '46.9', 'groupId': 'OG001', 'lowerLimit': '41.1', 'upperLimit': '52.8'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '67.4', 'groupId': 'OG000', 'lowerLimit': '61.9', 'upperLimit': '72.9'}, {'value': '64.6', 'groupId': 'OG001', 'lowerLimit': '59.0', 'upperLimit': '70.2'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '60.5', 'groupId': 'OG000', 'lowerLimit': '54.8', 'upperLimit': '66.3'}, {'value': '54.2', 'groupId': 'OG001', 'lowerLimit': '48.4', 'upperLimit': '59.9'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '50.4', 'groupId': 'OG000', 'lowerLimit': '44.6', 'upperLimit': '56.2'}, {'value': '47.3', 'groupId': 'OG001', 'lowerLimit': '41.5', 'upperLimit': '53.2'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '69.6', 'groupId': 'OG000', 'lowerLimit': '64.2', 'upperLimit': '74.9'}, {'value': '63.6', 'groupId': 'OG001', 'lowerLimit': '57.9', 'upperLimit': '69.2'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '74.7', 'groupId': 'OG000', 'lowerLimit': '69.6', 'upperLimit': '79.8'}, {'value': '65.4', 'groupId': 'OG001', 'lowerLimit': '59.8', 'upperLimit': '70.9'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '55.5', 'groupId': 'OG000', 'lowerLimit': '49.6', 'upperLimit': '61.3'}, {'value': '55.6', 'groupId': 'OG001', 'lowerLimit': '49.8', 'upperLimit': '61.4'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '58.0', 'groupId': 'OG000', 'lowerLimit': '52.2', 'upperLimit': '63.8'}, {'value': '57.8', 'groupId': 'OG001', 'lowerLimit': '52.0', 'upperLimit': '63.6'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '73.9', 'groupId': 'OG000', 'lowerLimit': '68.8', 'upperLimit': '79.1'}, {'value': '70.4', 'groupId': 'OG001', 'lowerLimit': '65.1', 'upperLimit': '75.7'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '75.4', 'groupId': 'OG000', 'lowerLimit': '70.5', 'upperLimit': '80.4'}, {'value': '69.3', 'groupId': 'OG001', 'lowerLimit': '64.0', 'upperLimit': '74.7'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '68.9', 'groupId': 'OG000', 'lowerLimit': '63.4', 'upperLimit': '74.3'}, {'value': '68.3', 'groupId': 'OG001', 'lowerLimit': '62.8', 'upperLimit': '73.7'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '70.7', 'groupId': 'OG000', 'lowerLimit': '65.3', 'upperLimit': '76.0'}, {'value': '71.1', 'groupId': 'OG001', 'lowerLimit': '65.8', 'upperLimit': '76.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Intraretinal fluid and subretinal fluid were measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W to Faricimab PTI (Part 2)', 'description': 'In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)', 'description': 'In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Week 28', 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '0.3'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '0.5'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '1.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '0.5'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '1.2'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '1.2'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '1.1'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '1.2'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '1.9'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '1.1'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '2.0'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '1.6'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '2.0'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.8'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '1.4'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '1.6'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '2.0'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '2.0'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.9'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '2.2'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '2.1'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '2.2'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '2.5'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '2.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'ETDRS Letters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Participants with evaluable Week 24 BCVA were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W to Faricimab PTI (Part 2)', 'description': 'In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)', 'description': 'In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Week 28', 'categories': [{'measurements': [{'value': '85.5', 'groupId': 'OG000', 'lowerLimit': '81.4', 'upperLimit': '89.6'}, {'value': '84.1', 'groupId': 'OG001', 'lowerLimit': '79.8', 'upperLimit': '88.3'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '89.1', 'groupId': 'OG000', 'lowerLimit': '85.5', 'upperLimit': '92.7'}, {'value': '87.7', 'groupId': 'OG001', 'lowerLimit': '83.9', 'upperLimit': '91.5'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000', 'lowerLimit': '85.9', 'upperLimit': '93.1'}, {'value': '88.4', 'groupId': 'OG001', 'lowerLimit': '84.7', 'upperLimit': '92.2'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000', 'lowerLimit': '85.9', 'upperLimit': '93.0'}, {'value': '88.0', 'groupId': 'OG001', 'lowerLimit': '84.2', 'upperLimit': '91.8'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '89.9', 'groupId': 'OG000', 'lowerLimit': '86.3', 'upperLimit': '93.4'}, {'value': '86.3', 'groupId': 'OG001', 'lowerLimit': '82.2', 'upperLimit': '90.3'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000', 'lowerLimit': '85.9', 'upperLimit': '93.1'}, {'value': '86.6', 'groupId': 'OG001', 'lowerLimit': '82.6', 'upperLimit': '90.6'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '89.9', 'groupId': 'OG000', 'lowerLimit': '86.3', 'upperLimit': '93.4'}, {'value': '87.7', 'groupId': 'OG001', 'lowerLimit': '83.9', 'upperLimit': '91.6'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000', 'lowerLimit': '84.3', 'upperLimit': '91.8'}, {'value': '86.6', 'groupId': 'OG001', 'lowerLimit': '82.6', 'upperLimit': '90.6'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '88.8', 'groupId': 'OG000', 'lowerLimit': '85.1', 'upperLimit': '92.5'}, {'value': '87.0', 'groupId': 'OG001', 'lowerLimit': '83.0', 'upperLimit': '90.9'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000', 'lowerLimit': '85.9', 'upperLimit': '93.1'}, {'value': '86.6', 'groupId': 'OG001', 'lowerLimit': '82.6', 'upperLimit': '90.6'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000', 'lowerLimit': '84.7', 'upperLimit': '92.1'}, {'value': '87.0', 'groupId': 'OG001', 'lowerLimit': '83.0', 'upperLimit': '90.9'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000', 'lowerLimit': '84.7', 'upperLimit': '92.1'}, {'value': '87.0', 'groupId': 'OG001', 'lowerLimit': '83.0', 'upperLimit': '90.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W to Faricimab PTI (Part 2)', 'description': 'In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)', 'description': 'In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Week 28', 'categories': [{'measurements': [{'value': '84.8', 'groupId': 'OG000', 'lowerLimit': '80.6', 'upperLimit': '89.0'}, {'value': '82.3', 'groupId': 'OG001', 'lowerLimit': '77.8', 'upperLimit': '86.7'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '88.8', 'groupId': 'OG000', 'lowerLimit': '85.1', 'upperLimit': '92.5'}, {'value': '85.9', 'groupId': 'OG001', 'lowerLimit': '81.8', 'upperLimit': '89.9'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '87.3', 'groupId': 'OG000', 'lowerLimit': '83.4', 'upperLimit': '91.2'}, {'value': '87.0', 'groupId': 'OG001', 'lowerLimit': '83.0', 'upperLimit': '90.9'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '87.7', 'groupId': 'OG000', 'lowerLimit': '83.8', 'upperLimit': '91.5'}, {'value': '86.3', 'groupId': 'OG001', 'lowerLimit': '82.2', 'upperLimit': '90.3'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '88.8', 'groupId': 'OG000', 'lowerLimit': '85.1', 'upperLimit': '92.5'}, {'value': '85.5', 'groupId': 'OG001', 'lowerLimit': '81.4', 'upperLimit': '89.7'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000', 'lowerLimit': '84.7', 'upperLimit': '92.2'}, {'value': '85.2', 'groupId': 'OG001', 'lowerLimit': '81.0', 'upperLimit': '89.3'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000', 'lowerLimit': '84.7', 'upperLimit': '92.2'}, {'value': '85.2', 'groupId': 'OG001', 'lowerLimit': '81.0', 'upperLimit': '89.3'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '86.2', 'groupId': 'OG000', 'lowerLimit': '82.2', 'upperLimit': '90.2'}, {'value': '83.4', 'groupId': 'OG001', 'lowerLimit': '79.0', 'upperLimit': '87.7'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '86.9', 'groupId': 'OG000', 'lowerLimit': '83.0', 'upperLimit': '90.9'}, {'value': '83.4', 'groupId': 'OG001', 'lowerLimit': '79.0', 'upperLimit': '87.7'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '86.9', 'groupId': 'OG000', 'lowerLimit': '83.0', 'upperLimit': '90.9'}, {'value': '85.2', 'groupId': 'OG001', 'lowerLimit': '81.0', 'upperLimit': '89.4'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '86.6', 'groupId': 'OG000', 'lowerLimit': '82.6', 'upperLimit': '90.6'}, {'value': '85.5', 'groupId': 'OG001', 'lowerLimit': '81.4', 'upperLimit': '89.7'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '86.6', 'groupId': 'OG000', 'lowerLimit': '82.6', 'upperLimit': '90.6'}, {'value': '85.5', 'groupId': 'OG001', 'lowerLimit': '81.4', 'upperLimit': '89.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W to Faricimab PTI (Part 2)', 'description': 'In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)', 'description': 'In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Week 28', 'categories': [{'measurements': [{'value': '74.6', 'groupId': 'OG000', 'lowerLimit': '69.5', 'upperLimit': '79.7'}, {'value': '73.6', 'groupId': 'OG001', 'lowerLimit': '68.5', 'upperLimit': '78.8'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000', 'lowerLimit': '75.4', 'upperLimit': '84.7'}, {'value': '77.2', 'groupId': 'OG001', 'lowerLimit': '72.3', 'upperLimit': '82.1'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '79.7', 'groupId': 'OG000', 'lowerLimit': '75.0', 'upperLimit': '84.4'}, {'value': '79.0', 'groupId': 'OG001', 'lowerLimit': '74.2', 'upperLimit': '83.8'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '78.6', 'groupId': 'OG000', 'lowerLimit': '73.8', 'upperLimit': '83.4'}, {'value': '78.3', 'groupId': 'OG001', 'lowerLimit': '73.5', 'upperLimit': '83.1'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '79.0', 'upperLimit': '87.7'}, {'value': '76.9', 'groupId': 'OG001', 'lowerLimit': '71.9', 'upperLimit': '81.9'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '82.6', 'groupId': 'OG000', 'lowerLimit': '78.2', 'upperLimit': '87.0'}, {'value': '79.4', 'groupId': 'OG001', 'lowerLimit': '74.6', 'upperLimit': '84.1'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '81.5', 'groupId': 'OG000', 'lowerLimit': '77.0', 'upperLimit': '86.0'}, {'value': '79.4', 'groupId': 'OG001', 'lowerLimit': '74.6', 'upperLimit': '84.1'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '76.4', 'groupId': 'OG000', 'lowerLimit': '71.5', 'upperLimit': '81.3'}, {'value': '78.3', 'groupId': 'OG001', 'lowerLimit': '73.5', 'upperLimit': '83.1'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '79.0', 'groupId': 'OG000', 'lowerLimit': '74.2', 'upperLimit': '83.7'}, {'value': '77.2', 'groupId': 'OG001', 'lowerLimit': '72.3', 'upperLimit': '82.1'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '77.9', 'groupId': 'OG000', 'lowerLimit': '73.0', 'upperLimit': '82.8'}, {'value': '76.1', 'groupId': 'OG001', 'lowerLimit': '71.1', 'upperLimit': '81.1'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '78.2', 'groupId': 'OG000', 'lowerLimit': '73.4', 'upperLimit': '83.1'}, {'value': '76.5', 'groupId': 'OG001', 'lowerLimit': '71.6', 'upperLimit': '81.5'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '77.5', 'groupId': 'OG000', 'lowerLimit': '72.7', 'upperLimit': '82.4'}, {'value': '77.6', 'groupId': 'OG001', 'lowerLimit': '72.7', 'upperLimit': '82.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W to Faricimab PTI (Part 2)', 'description': 'In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)', 'description': 'In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Week 28', 'categories': [{'measurements': [{'value': '46.4', 'groupId': 'OG000', 'lowerLimit': '40.6', 'upperLimit': '52.3'}, {'value': '51.3', 'groupId': 'OG001', 'lowerLimit': '45.4', 'upperLimit': '57.1'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '55.4', 'groupId': 'OG000', 'lowerLimit': '49.6', 'upperLimit': '61.2'}, {'value': '54.2', 'groupId': 'OG001', 'lowerLimit': '48.3', 'upperLimit': '60.0'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '55.1', 'groupId': 'OG000', 'lowerLimit': '49.2', 'upperLimit': '60.9'}, {'value': '52.7', 'groupId': 'OG001', 'lowerLimit': '46.9', 'upperLimit': '58.6'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '56.2', 'groupId': 'OG000', 'lowerLimit': '50.4', 'upperLimit': '62.0'}, {'value': '55.2', 'groupId': 'OG001', 'lowerLimit': '49.4', 'upperLimit': '61.1'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '62.4', 'groupId': 'OG000', 'lowerLimit': '56.7', 'upperLimit': '68.0'}, {'value': '56.0', 'groupId': 'OG001', 'lowerLimit': '50.1', 'upperLimit': '61.8'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '63.8', 'groupId': 'OG000', 'lowerLimit': '58.2', 'upperLimit': '69.4'}, {'value': '56.6', 'groupId': 'OG001', 'lowerLimit': '50.9', 'upperLimit': '62.4'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '59.8', 'groupId': 'OG000', 'lowerLimit': '54.1', 'upperLimit': '65.5'}, {'value': '58.5', 'groupId': 'OG001', 'lowerLimit': '52.7', 'upperLimit': '64.3'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '57.2', 'groupId': 'OG000', 'lowerLimit': '51.5', 'upperLimit': '63.0'}, {'value': '57.4', 'groupId': 'OG001', 'lowerLimit': '51.5', 'upperLimit': '63.2'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '58.0', 'groupId': 'OG000', 'lowerLimit': '52.1', 'upperLimit': '63.8'}, {'value': '60.3', 'groupId': 'OG001', 'lowerLimit': '54.5', 'upperLimit': '66.0'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '62.0', 'groupId': 'OG000', 'lowerLimit': '56.3', 'upperLimit': '67.7'}, {'value': '56.6', 'groupId': 'OG001', 'lowerLimit': '50.8', 'upperLimit': '62.5'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '60.9', 'groupId': 'OG000', 'lowerLimit': '55.1', 'upperLimit': '66.6'}, {'value': '58.8', 'groupId': 'OG001', 'lowerLimit': '53.1', 'upperLimit': '64.6'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '63.0', 'groupId': 'OG000', 'lowerLimit': '57.4', 'upperLimit': '68.7'}, {'value': '58.1', 'groupId': 'OG001', 'lowerLimit': '52.3', 'upperLimit': '63.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.'}, {'type': 'SECONDARY', 'title': 'Part 2: Percentage of Participants on Different Treatment Intervals at Week 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W to Faricimab PTI (Part 2)', 'description': 'In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)', 'description': 'In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Once Every 4 Weeks (Q4W)', 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000', 'lowerLimit': '17.4', 'upperLimit': '27.8'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '19.6', 'upperLimit': '30.4'}]}]}, {'title': 'Once Every 8 Weeks (Q8W)', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '17.5'}, {'value': '18.0', 'groupId': 'OG001', 'lowerLimit': '13.2', 'upperLimit': '22.9'}]}]}, {'title': 'Once Every 12 Weeks (Q12W)', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '15.7'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '5.8', 'upperLimit': '13.1'}]}]}, {'title': 'Once Every 16 Weeks (Q16W)', 'categories': [{'measurements': [{'value': '52.4', 'groupId': 'OG000', 'lowerLimit': '46.2', 'upperLimit': '58.6'}, {'value': '47.5', 'groupId': 'OG001', 'lowerLimit': '41.3', 'upperLimit': '53.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 68', 'description': 'In Part 2 of the study, participants in both the faricimab Q4W and aflibercept Q4W arms in Part 1 received 6 mg faricimab intravitreal injections administered according to a personalized treatment interval (PTI) dosing regimen in intervals between Q4W and Q16W. At faricimab dosing visits, treatment intervals were maintained or adjusted (i.e., increased by 4 weeks or decreased by 4, 8, or 12 weeks), based on central subfield thickness (CST) and BCVA values.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who had not discontinued the study at Week 68.'}, {'type': 'SECONDARY', 'title': 'Part 2: Number of Study Drug Injections Received in the Study Eye From Week 24 Through Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W to Faricimab PTI (Part 2)', 'description': 'In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)', 'description': 'In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '12'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Week 24 to Week 72', 'unitOfMeasure': 'Injections', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety-Evaluable Population: All participants randomized in the study who received at least one injection of active study drug in the study eye. For Part 2, the safety analysis included: in Arm A, all participants with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, all participants who received at least one faricimab dose.'}, {'type': 'SECONDARY', 'title': 'Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}, {'value': '267', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG002', 'title': 'Arm A: Faricimab Q4W to Faricimab PTI (Part 2)', 'description': 'In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG003', 'title': 'Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)', 'description': 'In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Adverse Event (AE)', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}]}, {'title': 'AE by Severity: Mild', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}]}, {'title': 'AE by Severity: Moderate', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'AE by Severity: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'AE by Severity: Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Serious Adverse Event (SAE)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'AE Leading to Withdrawal from Study Treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Treatment Related AEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Treatment Related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any AE of Special Interest (AESI)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'AESI: Drop in Visual Acuity Score ≥30', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72', 'description': 'This analysis of adverse events (AEs) only includes ocular AEs that occurred in the study eye. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. Ocular AEs of special interest included the following: Suspected transmission of an infectious agent by the study drug; Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, require surgical or medical intervention to prevent permanent loss of sight, or are associated with severe intraocular inflammation (IOI).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety-Evaluable Population: All participants randomized in the study who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, the safety analysis included: in Arm A, all participants with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168 (6 were excluded); in Arm B, all participants who received at least one faricimab dose (7 were excluded).'}, {'type': 'SECONDARY', 'title': 'Incidence of Ocular Adverse Events in the Fellow Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}, {'value': '267', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG002', 'title': 'Arm A: Faricimab Q4W to Faricimab PTI (Part 2)', 'description': 'In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG003', 'title': 'Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)', 'description': 'In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Adverse Event (AE)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}]}, {'title': 'Serious Adverse Event (SAE)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any AE of Special Interest (AESI)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72', 'description': 'This analysis of adverse events (AEs) only includes ocular AEs that occurred in the fellow eye. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. Ocular AEs of special interest included the following: Suspected transmission of an infectious agent by the study drug; Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, require surgical or medical intervention to prevent permanent loss of sight, or are associated with severe intraocular inflammation (IOI).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety-Evaluable Population: All participants randomized in the study who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, the safety analysis included: in Arm A, all participants with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168 (6 excluded); in Arm B, all participants who received at least one faricimab dose (7 excluded).'}, {'type': 'SECONDARY', 'title': 'Incidence of Non-Ocular Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}, {'value': '267', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).'}, {'id': 'OG002', 'title': 'Arm A: Faricimab Q4W to Faricimab PTI (Part 2)', 'description': 'In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG003', 'title': 'Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)', 'description': 'In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Adverse Event (AE)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '126', 'groupId': 'OG003'}]}]}, {'title': 'Serious Adverse Event (SAE)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}, {'title': 'AE Leading to Withdrawal from Study Treatment', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Any AE of Special Interest (AESI)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72', 'description': "This analysis of adverse events (AEs) only includes non-ocular (systemic) AEs. Investigators sought information on adverse events (AEs) at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. The non-ocular AE of special interest was: Cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety-Evaluable Population: All participants randomized in the study who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, the safety analysis included: in Arm A, all participants with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168 (6 excluded); in Arm B, all participants who received at least one faricimab dose (7 excluded).'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of Faricimab Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'spread': '0.0000', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0215', 'spread': '0.0160', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0220', 'spread': '0.0181', 'groupId': 'OG000'}, {'value': '0.0005', 'spread': '0.0006', 'groupId': 'OG001'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0040', 'spread': '0.0072', 'groupId': 'OG000'}, {'value': '0.0025', 'spread': '0.077', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0061', 'spread': '0.0110', 'groupId': 'OG000'}, {'value': '0.0097', 'spread': '0.0156', 'groupId': 'OG001'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0076', 'spread': '0.0109', 'groupId': 'OG000'}, {'value': '0.0087', 'spread': '0.0146', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72', 'unitOfMeasure': 'microgram per millilitre (μg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic-Evaluable Population: All safety- evaluable participants randomized to faricimab arm or who received faricimab with at least one plasma sample, provided sufficient dosing information (dose and dosing time) is available. The number analyzed indicates all participants who provided a PK sample at a given timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and Post-Baseline During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}, {'value': '540', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG001', 'title': 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'OG002', 'title': 'All Faricimab Participants', 'description': 'This immunogenicity analysis group represents all participants with an evaluable ADA sample. At baseline, evaluable participants were those with an ADA sample prior to faricimab injection, including those who did not receive study treatment; post-baseline, evaluable participants were those with an ADA sample after having received at least one dose of faricimab.'}], 'classes': [{'title': 'Baseline (BL): Total ADA-Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}, {'value': '540', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Post-BL: Total ADA-Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '538', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}]}]}, {'title': 'Post-BL: Treatment-Emergent ADA-Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '538', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}]}, {'title': 'Post-BL: Treatment-Unaffected ADA-Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '538', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72', 'description': 'Anti-drug antibodies (ADAs) against fariciamb were detected in plasma using a validated bridging enzyme-linked immunosorbent assay (ELISA). The number of participants with treatment-emergent ADA-positive samples includes post-baseline evaluable participants with at least one treatment-induced (defined as having an ADA-negative sample or missing sample at baseline and any positive post-baseline sample) or treatment-boosted (defined as having an ADA-positive sample at baseline and any positive post-baseline sample with a titer that is equal to or greater than 4-fold baseline titer) ADA-positive sample during the study treatment period. Treatment-unaffected ADA-positive is a post-baseline sample with a titer that is lower than 4-fold the ADA-positive baseline titer (faricimab arm) or the ADA-positive titer prior to first faricimab injection (aflibercept arm).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The immunogenicity analysis included all participants with an evaluable ADA sample. At baseline, evaluable participants were those with an ADA sample prior to faricimab injection, including those who did not receive study treatment; post-baseline, evaluable participants were those with an ADA sample after having received at least one dose of faricimab.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'FG001', 'title': 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}], 'periods': [{'title': 'Part 1 (Baseline up to Week 24)', 'milestones': [{'type': 'STARTED', 'comment': 'Intent-to-Treat (ITT) Population', 'achievements': [{'comment': 'All randomized participants', 'groupId': 'FG000', 'numSubjects': '276'}, {'comment': 'All randomized participants', 'groupId': 'FG001', 'numSubjects': '277'}]}, {'type': 'Received at Least One Dose of Study Drug', 'comment': 'Safety-Evaluable Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '276'}, {'groupId': 'FG001', 'numSubjects': '274'}]}, {'type': 'COMPLETED', 'comment': 'Completed Part 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '271'}, {'groupId': 'FG001', 'numSubjects': '274'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Part 2 (Week 24 to Week 72)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '271'}, {'groupId': 'FG001', 'numSubjects': '274'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '245'}, {'groupId': 'FG001', 'numSubjects': '244'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Patient Missed Week 72 Visit Due to SAE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Non-Compliance With Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Patient Could Not Return to Hospital Due to COVID-19 Epidemic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Patient Refused to Continue Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 768 patients were screened; 9 of these patients were rescreened and randomized in the study. A total of 215 patients failed screening due to not meeting the inclusion criteria. A total of 553 patients with BRVO were randomized 1:1 into the study: 276 to the faricimab Q4W arm and 277 to the aflibercept Q4W arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'BG000'}, {'value': '277', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'BG001', 'title': 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.3', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '63.8', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '64.1', 'spread': '10.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '273', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '448', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '344', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'categories': [{'title': 'Rest of the World', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}, {'title': 'Asia', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}, {'title': 'USA and Canada', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants by the Eye (Left or Right) Chosen as the Study Eye', 'classes': [{'categories': [{'title': 'Left Eye', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '267', 'groupId': 'BG002'}]}, {'title': 'Right Eye', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye', 'classes': [{'categories': [{'measurements': [{'value': '57.50', 'spread': '13.04', 'groupId': 'BG000'}, {'value': '57.64', 'spread': '12.15', 'groupId': 'BG001'}, {'value': '57.57', 'spread': '12.59', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ETDRS Letters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Participants by the BCVA Letter Score Categories in the Study Eye', 'classes': [{'categories': [{'title': '≤54 Letters (20/80 or Worse)', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}, {'title': '≥55 Letters (20/80 or Better)', 'measurements': [{'value': '187', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '374', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'ITT Population: All global participants who were randomized in the study, according to the assigned treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-17', 'size': 2226023, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-22T09:46', 'hasProtocol': True}, {'date': '2022-10-03', 'size': 2782685, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-22T09:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 553}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'dispFirstSubmitDate': '2023-06-02', 'completionDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-11', 'studyFirstSubmitDate': '2021-02-03', 'resultsFirstSubmitDate': '2023-11-22', 'studyFirstSubmitQcDate': '2021-02-03', 'dispFirstPostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-20', 'studyFirstPostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24', 'timeFrame': 'From Baseline through Week 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.'}], 'secondaryOutcomes': [{'measure': 'Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Part 1: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Part 1: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Part 1: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (\\>38 and ≤38 letters) and region (U.S. and Canada, Asia, and rest of the world). All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Part 1: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline CST (continuous), and randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Part 1: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': "Absence of diabetic macular edema was defined as achieving a central subfield thickness of \\<325 microns in the study eye. Central subfield thickness was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI."}, {'measure': 'Part 1: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Intraretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Part 1: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Subretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Part 1: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, and 24', 'description': 'Intraretinal fluid and subretinal fluid were measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Part 1: Change From Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': "The NEI VFQ-25 captures a patient's perception of vision-related functioning and vision-related quality of life. The core measure includes 25 items that comprise 11 vision-related subscales and 1 item on general health. The composite score ranges from 0 to 100, with higher scores indicating better vision-related functioning. For the ANCOVA analysis, the model uses the non-missing change from baseline in BCVA at Weeks 24 as the response variables adjusted for the treatment group, baseline NEI VFQ-25 Composite Score (continuous), baseline BCVA score (≥55 and ≤54 letters) and region (U.S. and Canada, Asia, and the rest of the world). Observed NEI VFQ-25 assessments were used regardless of the occurrence of intercurrent events. Missing data were not imputed. 95% CI is a rounding of 95.03% CI."}, {'measure': 'Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (\\>38 and ≤38 letters) and region (U.S. and Canada, Asia, and rest of the world). All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Parts 1 and 2: Change From Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints Through Week 72', 'timeFrame': 'Baseline and Weeks 24, 48, and 72', 'description': "The NEI VFQ-25 captures a patient's perception of vision-related functioning and vision-related quality of life. The core measure includes 25 items that comprise 11 vision-related subscales and 1 item on general health. The composite score ranges from 0 to 100, with higher scores indicating better vision-related functioning. For the MMRM analysis, the model adjusted for the treatment group, visit, visit-by-treatment group interaction, baseline NEI VFQ-25 Composite Score continuous), baseline BCVA score (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and the rest of the world). Observed NEI VFQ-25 assessments were used regardless of the occurrence of intercurrent events. Missing data were implicitly imputed. Invalid BCVA values were excluded. 95% CI is a rounding of 95.03% CI."}, {'measure': 'Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline CST (continuous), and randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': "Absence of diabetic macular edema was defined as achieving a central subfield thickness of \\<325 microns in the study eye. Central subfield thickness was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI."}, {'measure': 'Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Intraretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Subretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Intraretinal fluid and subretinal fluid were measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72', 'timeFrame': 'Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72', 'timeFrame': 'Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72', 'timeFrame': 'Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72', 'timeFrame': 'Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72', 'timeFrame': 'Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72', 'description': 'Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \\[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.'}, {'measure': 'Part 2: Percentage of Participants on Different Treatment Intervals at Week 68', 'timeFrame': 'Week 68', 'description': 'In Part 2 of the study, participants in both the faricimab Q4W and aflibercept Q4W arms in Part 1 received 6 mg faricimab intravitreal injections administered according to a personalized treatment interval (PTI) dosing regimen in intervals between Q4W and Q16W. At faricimab dosing visits, treatment intervals were maintained or adjusted (i.e., increased by 4 weeks or decreased by 4, 8, or 12 weeks), based on central subfield thickness (CST) and BCVA values.'}, {'measure': 'Part 2: Number of Study Drug Injections Received in the Study Eye From Week 24 Through Week 72', 'timeFrame': 'From Week 24 to Week 72'}, {'measure': 'Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale', 'timeFrame': 'Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72', 'description': 'This analysis of adverse events (AEs) only includes ocular AEs that occurred in the study eye. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. Ocular AEs of special interest included the following: Suspected transmission of an infectious agent by the study drug; Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, require surgical or medical intervention to prevent permanent loss of sight, or are associated with severe intraocular inflammation (IOI).'}, {'measure': 'Incidence of Ocular Adverse Events in the Fellow Eye', 'timeFrame': 'Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72', 'description': 'This analysis of adverse events (AEs) only includes ocular AEs that occurred in the fellow eye. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. Ocular AEs of special interest included the following: Suspected transmission of an infectious agent by the study drug; Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, require surgical or medical intervention to prevent permanent loss of sight, or are associated with severe intraocular inflammation (IOI).'}, {'measure': 'Incidence of Non-Ocular Adverse Events', 'timeFrame': 'Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72', 'description': "This analysis of adverse events (AEs) only includes non-ocular (systemic) AEs. Investigators sought information on adverse events (AEs) at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. The non-ocular AE of special interest was: Cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law."}, {'measure': 'Plasma Concentration of Faricimab Over Time', 'timeFrame': 'Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72'}, {'measure': 'Number of Participants With Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and Post-Baseline During the Study', 'timeFrame': 'Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72', 'description': 'Anti-drug antibodies (ADAs) against fariciamb were detected in plasma using a validated bridging enzyme-linked immunosorbent assay (ELISA). The number of participants with treatment-emergent ADA-positive samples includes post-baseline evaluable participants with at least one treatment-induced (defined as having an ADA-negative sample or missing sample at baseline and any positive post-baseline sample) or treatment-boosted (defined as having an ADA-positive sample at baseline and any positive post-baseline sample with a titer that is equal to or greater than 4-fold baseline titer) ADA-positive sample during the study treatment period. Treatment-unaffected ADA-positive is a post-baseline sample with a titer that is lower than 4-fold the ADA-positive baseline titer (faricimab arm) or the ADA-positive titer prior to first faricimab injection (aflibercept arm).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BRVO'], 'conditions': ['Macular Edema', 'Branch Retinal Vein Occlusion']}, 'referencesModule': {'references': [{'pmid': '36912792', 'type': 'DERIVED', 'citation': 'Romano F, Lamanna F, Gabrielle PH, Teo KYC, Battaglia Parodi M, Iacono P, Fraser-Bell S, Cornish EE, Nassisi M, Viola F, Agarwal A, Samanta A, Chhablani J, Staurenghi G, Invernizzi A. Update on Retinal Vein Occlusion. Asia Pac J Ophthalmol (Phila). 2023 Mar-Apr 01;12(2):196-210. doi: 10.1097/APO.0000000000000598. Epub 2023 Feb 14.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in participants with macular edema due to branch retinal vein occlusion (BRVO).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Foveal center-involved macular edema due to branch retinal vein occlusion (BRVO), diagnosed no longer than 4 months prior to the screening visit\n* Best-corrected visual acuity (BCVA) of 73 to 19 letters, inclusive (20/40 to 20/400 approximate Snellen equivalent) on Day 1\n* Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis\n* For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs during the treatment period and for 3 months after the final dose of study treatment\n\nExclusion Criteria:\n\n* Any major illness or major surgical procedure within 1 month before screening\n* Uncontrolled blood pressure\n* Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1\n* Pregnant or breastfeeding, or intending to become pregnant during the study\n\nOcular Exclusion Criteria for Study Eye:\n\n* History of previous episodes of macular edema due to RVO or persistent macular edema due to RVO diagnosed more than 4 months before screening\n* Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than macular edema due to RVO in the study eye (e.g., ischemic maculopathy, Irvine-Gass syndrome, foveal atrophy, foveal fibrosis, pigment abnormalities, dense subfoveal hard exudates, or other non-retinal conditions)\n* Macular laser (focal/grid) in the study eye at any time prior to Day 1\n* Panretinal photocoagulation in the study eye within 3 months prior to Day 1 or anticipated within 3 months of study start on Day 1\n* Any prior or current treatment for macular edema; macular neovascularization, including diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD); and vitreomacular-interface abnormalities, including, but not restricted to, IVT treatment with anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air or periocular injection\n* Any prior intervention with verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or vitreo-retinal surgery including sheatotomy\n* Any prior steroid implant use including dexamethasone intravitreal implant (Ozurdex) and fluocinolone acetonide intravitreal implant (Iluvien)\n\nOcular Exclusion Criteria for Both Eyes:\n\n* Prior IVT administration of faricimab in either eye\n* History of idiopathic or autoimmune-associated uveitis in either eye\n* Active periocular, ocular or intraocular inflammation or infection (including suspected) in either eye on Day 1'}, 'identificationModule': {'nctId': 'NCT04740905', 'acronym': 'BALATON', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion', 'orgStudyIdInfo': {'id': 'GR41984'}, 'secondaryIdInfos': [{'id': '2020-000440-63', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).', 'interventionNames': ['Drug: Faricimab', 'Procedure: Sham Procedure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)', 'description': 'In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).', 'interventionNames': ['Drug: Faricimab', 'Drug: Aflibercept', 'Procedure: Sham Procedure']}], 'interventions': [{'name': 'Faricimab', 'type': 'DRUG', 'otherNames': ['VABYSMO®', 'faricimab-svoa', 'RO6867461', 'RG7716'], 'description': 'Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.', 'armGroupLabels': ['Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)']}, {'name': 'Aflibercept', 'type': 'DRUG', 'otherNames': ['Eylea'], 'description': 'Aflibercept 2 mg will be administered by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).', 'armGroupLabels': ['Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)']}, {'name': 'Sham Procedure', 'type': 'PROCEDURE', 'description': 'The sham is a procedure that mimics an intravitreal (IVT) injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.', 'armGroupLabels': ['Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)', 'Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85014', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retinal Research Institute, LLC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retina Associates Southwest PC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '95008', 'city': 'Campbell', 'state': 'California', 'country': 'United States', 'facility': 'Retinal Diagnostic Center', 'geoPoint': {'lat': 37.28717, 'lon': -121.94996}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'The Retina Partners', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '91107', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'California Eye Specialists Medical group Inc.', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '92064', 'city': 'Poway', 'state': 'California', 'country': 'United States', 'facility': 'Retina Consultants, San Diego', 'geoPoint': {'lat': 32.96282, 'lon': -117.03586}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Retina Consultants of Southern Colorado PC', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '06385', 'city': 'Waterford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Retina Group of New England', 'geoPoint': {'lat': 41.3417, 'lon': -72.13597}}, {'zip': '32901', 'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Eye Associates', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'zip': '33324', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Fort Lauderdale Eye Institute', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '33711', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Vitreous Assoc of FL', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Southern Vitreoretinal Assoc', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Associates of Florida, LLC', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Southeast Retina Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30060-1137', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Retina PC', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '96701', 'city': '‘Aiea', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Retina Consultants of Hawaii', 'geoPoint': {'lat': 21.38222, 'lon': -157.93361}}, {'zip': '60452', 'city': 'Oak Forest', 'state': 'Illinois', 'country': 'United States', 'facility': 'University Retina and Macula Associates, PC', 'geoPoint': {'lat': 41.60281, 'lon': -87.74394}}, {'zip': '62704', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Prairie Retina Center', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '21740', 'city': 'Hagerstown', 'state': 'Maryland', 'country': 'United States', 'facility': 'Cumberland Valley Retina PC', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center; Ophthalmology', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Assoc Retinal Consultants PC', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Midwest Vision Research Foundation', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Sierra Eye Associates', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '07666', 'city': 'Teaneck', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Retina Associates of NJ', 'geoPoint': {'lat': 40.8976, 'lon': -74.01597}}, {'zip': '11788', 'city': 'Hauppauge', 'state': 'New York', 'country': 'United States', 'facility': 'Long Is. 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