Viewing Study NCT03481634

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Ignite Creation Date: 2025-12-25 @ 2:28 AM
Ignite Modification Date: 2025-12-26 @ 1:02 AM
Study NCT ID: NCT03481634
Status: COMPLETED
Last Update Posted: 2023-01-30
First Post: 2018-03-13
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008269', 'term': 'Macular Edema'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000622091', 'term': 'brolucizumab'}, {'id': 'C533178', 'term': 'aflibercept'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@Novartis.com', 'phone': '+ 1 862 778 8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Brolucizumab 3mg', 'description': 'Brolucizumab 3mg', 'otherNumAtRisk': 190, 'deathsNumAtRisk': 190, 'otherNumAffected': 146, 'seriousNumAtRisk': 190, 'deathsNumAffected': 4, 'seriousNumAffected': 58}, {'id': 'EG001', 'title': 'Brolucizumab 6mg', 'description': 'Brolucizumab 6mg', 'otherNumAtRisk': 189, 'deathsNumAtRisk': 189, 'otherNumAffected': 148, 'seriousNumAtRisk': 189, 'deathsNumAffected': 8, 'seriousNumAffected': 59}, {'id': 'EG002', 'title': 'Aflibercept 2mg', 'description': 'Aflibercept 2mg', 'otherNumAtRisk': 187, 'deathsNumAtRisk': 187, 'otherNumAffected': 137, 'seriousNumAtRisk': 187, 'deathsNumAffected': 7, 'seriousNumAffected': 63}, {'id': 'EG003', 'title': 'Overall', 'description': 'Overall', 'otherNumAtRisk': 566, 'deathsNumAtRisk': 566, 'otherNumAffected': 431, 'seriousNumAtRisk': 566, 'deathsNumAffected': 19, 'seriousNumAffected': 180}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 10}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Blepharitis - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 13}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Blepharitis - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Cataract - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 28}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Cataract - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 39}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Cataract subcapsular - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Conjunctival haemorrhage - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Conjunctival haemorrhage - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 54}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Conjunctival hyperaemia - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Conjunctivitis allergic - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Diabetic retinal oedema - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 41}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Diabetic retinal oedema - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 25}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Diabetic retinopathy - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 20}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Dry eye - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 19}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Dry eye - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 22}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Eye irritation - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Eye irritation - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Eye pain - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Eye pain - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Iridocyclitis - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Keratitis - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Macular oedema - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 13}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Ocular hypertension - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Ocular hypertension - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Posterior capsule opacification - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Punctate keratitis - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Retinal exudates - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Retinal exudates - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Retinal haemorrhage - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Retinal haemorrhage - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Vision blurred - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Visual acuity reduced - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Visual acuity reduced - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 18}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Vitreoretinal traction syndrome - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Vitreous detachment - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Vitreous detachment - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 22}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Vitreous floaters - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 17}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Vitreous floaters - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 23}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Vitreous haemorrhage - Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 13}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Vitreous haemorrhage - Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 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190, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 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'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pulmonary congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Accelerated hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Dry gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Embolism venous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hypertensive urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 190, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 189, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 187, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 566, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'LS mean estimate (Brolucizumab 3 mg vs. Aflibercept 2 mg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.3', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '0.67', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 6 mg vs. Aflibercept 2 mg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '0.57', 'groupId': 'OG001'}, {'value': '10.5', 'spread': '0.57', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '0.3', 'pValueComment': '1-sided p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.81', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority (4-letter margin)'}, {'pValue': '0.227', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.3', 'ciLowerLimit': '-5.1', 'ciUpperLimit': '-1.4', 'pValueComment': '1-sided p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.94', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority (4-letter margin)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.\n\nThis endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - Last observation carried forward (LOCF).\n\nThis endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept'}, {'type': 'SECONDARY', 'title': 'Average Change From Baseline in BCVA Over the Period Week 40 Through Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'LS mean estimate (Brolucizumab 3 mg vs. Aflibercept 2 mg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '10.5', 'spread': '0.64', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 6 mg vs. Aflibercept 2 mg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.0', 'spread': '0.53', 'groupId': 'OG001'}, {'value': '10.5', 'spread': '0.53', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '-0.0', 'pValueComment': '(1-sided)', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.75', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority (4-letter margin)'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.5', 'ciLowerLimit': '-5.2', 'ciUpperLimit': '-1.7', 'pValueComment': '(1-sided)', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.90', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority (4-letter margin)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 40 through Week 52 (average)', 'description': 'BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.\n\nThis endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - Observed.\n\nThis endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept'}, {'type': 'SECONDARY', 'title': 'Patients Maintained at q12w - Probability of Maintaining on q12w', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}], 'classes': [{'title': 'Prob. of maintaining on q12w - Week 0', 'categories': [{'measurements': [{'value': '1', 'comment': 'CIs are not applicable for probability = 1.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1', 'comment': 'CIs are not applicable for probability = 1.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Prob. of maintaining on q12w - Week 32', 'categories': [{'measurements': [{'value': '0.758', 'groupId': 'OG000', 'lowerLimit': '0.685', 'upperLimit': '0.816'}, {'value': '0.807', 'groupId': 'OG001', 'lowerLimit': '0.739', 'upperLimit': '0.860'}]}]}, {'title': 'Prob. of maintaining on q12w - Week 36', 'categories': [{'measurements': [{'value': '0.545', 'groupId': 'OG000', 'lowerLimit': '0.463', 'upperLimit': '0.619'}, {'value': '0.628', 'groupId': 'OG001', 'lowerLimit': '0.548', 'upperLimit': '0.698'}]}]}, {'title': 'Prob. of maintaining on q12w - Week 48', 'categories': [{'measurements': [{'value': '0.474', 'groupId': 'OG000', 'lowerLimit': '0.393', 'upperLimit': '0.551'}, {'value': '0.550', 'groupId': 'OG001', 'lowerLimit': '0.468', 'upperLimit': '0.625'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0), Weeks 32, 36 and 48', 'description': 'Positive treatment status is defined as intravitreal (IVT) injections per planned dosing regimen \\[every 12 weeks (q12w)\\]. This outcome measure is pre-specified for brolucizumab treatment arms only.', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - Efficacy/Safety approach'}, {'type': 'SECONDARY', 'title': 'Patients Maintained at q12w (for Those Patients Who Qualified for q12w at Week 36) - Probability of Maintaining on q12w', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}], 'classes': [{'title': 'Prob. of maintaining on q12w - Week 36', 'categories': [{'measurements': [{'value': '1', 'comment': 'CIs are not applicable for probability = 1.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1', 'comment': 'CIs are not applicable for probability = 1.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Prob. of maintaining on q12w - Week 48', 'categories': [{'measurements': [{'value': '0.870', 'groupId': 'OG000', 'lowerLimit': '0.772', 'upperLimit': '0.928'}, {'value': '0.876', 'groupId': 'OG001', 'lowerLimit': '0.788', 'upperLimit': '0.930'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 36 and 48', 'description': 'Positive treatment status is defined as intravitreal (IVT) injections per planned dosing regimen \\[every 8 weeks (q8w)\\]. This outcome measure is pre-specified for brolucizumab treatment arms only.', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - Efficacy/Safety approach'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BCVA at Each Visit up to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '185', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'Week 4 (n=187, 186, 185)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '185', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '5.02', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '5.22', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '6.74', 'groupId': 'OG002'}]}]}, {'title': 'Week 6 (n=185,186,180)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '5.86', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '6.22', 'groupId': 'OG001'}, {'value': '6.8', 'spread': '6.80', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 (n=183,184,181)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '5.90', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '6.54', 'groupId': 'OG001'}, {'value': '7.1', 'spread': '7.57', 'groupId': 'OG002'}]}]}, {'title': 'Week 12 (n=183,186,182)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '5.93', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '6.57', 'groupId': 'OG001'}, {'value': '8.1', 'spread': '7.63', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 (n=173,179,179)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}, {'value': '179', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '7.00', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '6.83', 'groupId': 'OG001'}, {'value': '8.5', 'spread': '7.36', 'groupId': 'OG002'}]}]}, {'title': 'Week 18 (n=175,181,172)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.6', 'spread': '6.35', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '6.84', 'groupId': 'OG001'}, {'value': '8.8', 'spread': '7.27', 'groupId': 'OG002'}]}]}, {'title': 'Week 20 (n=176,177,176)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '7.59', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '7.51', 'groupId': 'OG001'}, {'value': '9.8', 'spread': '7.47', 'groupId': 'OG002'}]}]}, {'title': 'Week 24 (n=174,178,177)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '6.42', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '7.08', 'groupId': 'OG001'}, {'value': '9.2', 'spread': '7.84', 'groupId': 'OG002'}]}]}, {'title': 'Week 28 (n=170,175,170)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.2', 'spread': '6.58', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '7.40', 'groupId': 'OG001'}, {'value': '10.3', 'spread': '7.26', 'groupId': 'OG002'}]}]}, {'title': 'Week 32 (n=155,161,162)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '162', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.2', 'spread': '7.76', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '7.20', 'groupId': 'OG001'}, {'value': '9.9', 'spread': '7.89', 'groupId': 'OG002'}]}]}, {'title': 'Week 36 (n=154,166,165)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '8.10', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '8.15', 'groupId': 'OG001'}, {'value': '10.2', 'spread': '7.84', 'groupId': 'OG002'}]}]}, {'title': 'Week 40 (n=160,163,163)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.3', 'spread': '10.47', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '7.99', 'groupId': 'OG001'}, {'value': '10.0', 'spread': '8.28', 'groupId': 'OG002'}]}]}, {'title': 'Week 44 (n=156,157,163)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': '10.92', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '7.66', 'groupId': 'OG001'}, {'value': '10.7', 'spread': '8.25', 'groupId': 'OG002'}]}]}, {'title': 'Week 48 (n=155,154,159)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '11.53', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '7.63', 'groupId': 'OG001'}, {'value': '11.1', 'spread': '8.75', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 (n=156,153,160)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '10.72', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '7.66', 'groupId': 'OG001'}, {'value': '10.7', 'spread': '8.87', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), Weeks 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, and 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS)'}, {'type': 'SECONDARY', 'title': 'BCVA (Letters Read): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (FAS - LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'LS mean estimate (Brolucizumab 3 mg vs Aflibercept 2 mg) (n=190, 0, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '0.78', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 6 mg vs Aflibercept 2 mg) (n=0, 189,187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.6', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '10.6', 'spread': '0.73', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.8', 'ciLowerLimit': '-6.0', 'ciUpperLimit': '-1.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.09', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.03', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, and Week 88 through Week 100 (average)', 'description': 'Visual acuity was assessed at every study visit using best correction determined from protocol refraction (BCVA). BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts.\n\nLS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.', 'unitOfMeasure': 'BCVA letters read', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - LOCF'}, {'type': 'SECONDARY', 'title': 'Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'Prob. of maintaining on q12w - Week 0', 'categories': [{'measurements': [{'value': '1', 'comment': 'Not applicable when probability = 1', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1', 'comment': 'Not applicable when probability = 1', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Prob. of maintaining on q12w - Week 32', 'categories': [{'measurements': [{'value': '0.758', 'groupId': 'OG000', 'lowerLimit': '0.685', 'upperLimit': '0.816'}, {'value': '0.807', 'groupId': 'OG001', 'lowerLimit': '0.739', 'upperLimit': '0.860'}]}]}, {'title': 'Prob. of maintaining on q12w - Week 36', 'categories': [{'measurements': [{'value': '0.545', 'groupId': 'OG000', 'lowerLimit': '0.463', 'upperLimit': '0.619'}, {'value': '0.628', 'groupId': 'OG001', 'lowerLimit': '0.548', 'upperLimit': '0.698'}]}]}, {'title': 'Prob. of maintaining on q12w - Week 48', 'categories': [{'measurements': [{'value': '0.474', 'groupId': 'OG000', 'lowerLimit': '0.393', 'upperLimit': '0.551'}, {'value': '0.550', 'groupId': 'OG001', 'lowerLimit': '0.468', 'upperLimit': '0.625'}]}]}, {'title': 'Prob. of maintaining on q12w - Week 60', 'categories': [{'measurements': [{'value': '0.403', 'groupId': 'OG000', 'lowerLimit': '0.323', 'upperLimit': '0.482'}, {'value': '0.520', 'groupId': 'OG001', 'lowerLimit': '0.437', 'upperLimit': '0.596'}]}]}, {'title': 'Prob. of maintaining on q12w - Week 72', 'categories': [{'measurements': [{'value': '0.394', 'groupId': 'OG000', 'lowerLimit': '0.314', 'upperLimit': '0.473'}, {'value': '0.487', 'groupId': 'OG001', 'lowerLimit': '0.404', 'upperLimit': '0.565'}]}]}, {'title': 'Prob. of maintaining on q12w - Week 84', 'categories': [{'measurements': [{'value': '0.365', 'groupId': 'OG000', 'lowerLimit': '0.285', 'upperLimit': '0.445'}, {'value': '0.460', 'groupId': 'OG001', 'lowerLimit': '0.376', 'upperLimit': '0.539'}]}]}, {'title': 'Prob. of maintaining on q12w - Week 96', 'categories': [{'measurements': [{'value': '0.334', 'groupId': 'OG000', 'lowerLimit': '0.254', 'upperLimit': '0.415'}, {'value': '0.441', 'groupId': 'OG001', 'lowerLimit': '0.357', 'upperLimit': '0.521'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0), Weeks 32, 36, 48, 60, 72, 84, and 96', 'description': 'This outcome measure is pre-specified for brolucizumab treatment arms only', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - Efficacy/Safety approach'}, {'type': 'SECONDARY', 'title': 'Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'Prob. of maintaining on q12w - Week 0', 'categories': [{'measurements': [{'value': '1', 'comment': 'Not applicable when probability = 1', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1', 'comment': 'Not applicable when probability = 1', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Prob. of maintaining on q12w - Week 32', 'categories': [{'measurements': [{'value': '1', 'comment': 'Not applicable when probability = 1', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1', 'comment': 'Not applicable when probability = 1', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Prob. of maintaining on q12w - Week 36', 'categories': [{'measurements': [{'value': '1', 'comment': 'Not applicable when probability = 1', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1', 'comment': 'Not applicable when probability = 1', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Prob. of maintaining on q12w - Week 48', 'categories': [{'measurements': [{'value': '0.870', 'groupId': 'OG000', 'lowerLimit': '0.772', 'upperLimit': '0.928'}, {'value': '0.876', 'groupId': 'OG001', 'lowerLimit': '0.788', 'upperLimit': '0.930'}]}]}, {'title': 'Prob. of maintaining on q12w - Week 60', 'categories': [{'measurements': [{'value': '0.740', 'groupId': 'OG000', 'lowerLimit': '0.622', 'upperLimit': '0.826'}, {'value': '0.828', 'groupId': 'OG001', 'lowerLimit': '0.730', 'upperLimit': '0.892'}]}]}, {'title': 'Prob. of maintaining on q12w - Week 72', 'categories': [{'measurements': [{'value': '0.723', 'groupId': 'OG000', 'lowerLimit': '0.603', 'upperLimit': '0.812'}, {'value': '0.775', 'groupId': 'OG001', 'lowerLimit': '0.670', 'upperLimit': '0.851'}]}]}, {'title': 'Prob. of maintaining on q12w - Week 84', 'categories': [{'measurements': [{'value': '0.670', 'groupId': 'OG000', 'lowerLimit': '0.544', 'upperLimit': '0.769'}, {'value': '0.732', 'groupId': 'OG001', 'lowerLimit': '0.621', 'upperLimit': '0.816'}]}]}, {'title': 'Prob. of maintaining on q12w - Week 96', 'categories': [{'measurements': [{'value': '0.613', 'groupId': 'OG000', 'lowerLimit': '0.482', 'upperLimit': '0.720'}, {'value': '0.702', 'groupId': 'OG001', 'lowerLimit': '0.587', 'upperLimit': '0.791'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0), Weeks 32, 36, 48, 60, 72, 84, and 96', 'description': 'This outcome measure is pre-specified for brolucizumab treatment arms only', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - Efficacy/Safety approach'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 4 (n=190, 0, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-104.7', 'spread': '6.11', 'groupId': 'OG000'}, {'value': '-104.1', 'spread': '6.15', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 4 (n=0, 189, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-105.6', 'spread': '5.92', 'groupId': 'OG001'}, {'value': '-103.4', 'spread': '5.95', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 6 (n=190, 0, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-107.1', 'spread': '6.24', 'groupId': 'OG000'}, {'value': '-119.3', 'spread': '6.29', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 6 (n=0, 189, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-116.1', 'spread': '5.89', 'groupId': 'OG001'}, {'value': '-118.6', 'spread': '5.92', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 8 (n=190, 0, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-125.1', 'spread': '6.06', 'groupId': 'OG000'}, {'value': '-126.1', 'spread': '6.11', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg)- Week 8 (n=0, 189, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-128.9', 'spread': '5.82', 'groupId': 'OG001'}, {'value': '-125.6', 'spread': '5.86', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 12 (n=190, 0, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-131.0', 'spread': '6.14', 'groupId': 'OG000'}, {'value': '-137.4', 'spread': '6.19', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 12 (n=0, 189, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-134.5', 'spread': '6.22', 'groupId': 'OG001'}, {'value': '-137.3', 'spread': '6.26', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 16 (n=190, 0, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-142.3', 'spread': '5.98', 'groupId': 'OG000'}, {'value': '-143.3', 'spread': '6.02', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 16 (n=0, 189, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-146.5', 'spread': '5.83', 'groupId': 'OG001'}, {'value': '-143.1', 'spread': '5.86', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 18 (n=190, 0, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-138.1', 'spread': '6.27', 'groupId': 'OG000'}, {'value': '-147.0', 'spread': '6.32', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 18 (n=0, 189, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-144.2', 'spread': '5.96', 'groupId': 'OG001'}, {'value': '-146.8', 'spread': '5.99', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 20 (n=190, 0, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-151.8', 'spread': '6.01', 'groupId': 'OG000'}, {'value': '-148.3', 'spread': '6.06', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 20 (n=0, 189, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-153.8', 'spread': '5.71', 'groupId': 'OG001'}, {'value': '-148.0', 'spread': '5.74', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 24 (n=190, 0, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-152.6', 'spread': '6.37', 'groupId': 'OG000'}, {'value': '-138.7', 'spread': '6.42', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 24 (n=0, 189, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-156.2', 'spread': '6.30', 'groupId': 'OG001'}, {'value': '-138.4', 'spread': '6.33', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 28 (n=190, 0, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-163.4', 'spread': '5.81', 'groupId': 'OG000'}, {'value': '-154.6', 'spread': '5.85', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 28 (n=0, 189, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-163.3', 'spread': '5.97', 'groupId': 'OG001'}, {'value': '-154.6', 'spread': '6.00', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 32 (n=190, 0, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-147.4', 'spread': '6.68', 'groupId': 'OG000'}, {'value': '-144.3', 'spread': '6.73', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 32 (n=0, 189, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-156.0', 'spread': '6.35', 'groupId': 'OG001'}, {'value': '-144.2', 'spread': '6.38', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 36 (n=190, 0, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-119.8', 'spread': '7.74', 'groupId': 'OG000'}, {'value': '-156.0', 'spread': '7.81', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 36 (n=0, 189, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-135.1', 'spread': '7.01', 'groupId': 'OG001'}, {'value': '-155.5', 'spread': '7.05', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 40 (n=190, 0, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-155.8', 'spread': '6.46', 'groupId': 'OG000'}, {'value': '-149.7', 'spread': '6.51', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 40 (n=0, 189, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-156.9', 'spread': '6.68', 'groupId': 'OG001'}, {'value': '-150.4', 'spread': '6.72', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 44 (n=190, 0, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-155.4', 'spread': '6.56', 'groupId': 'OG000'}, {'value': '-163.4', 'spread': '6.62', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 44 (n=0, 189, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-162.2', 'spread': '6.17', 'groupId': 'OG001'}, {'value': '-163.3', 'spread': '6.21', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 48 (n=190, 0, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-144.2', 'spread': '6.92', 'groupId': 'OG000'}, {'value': '-157.8', 'spread': '6.98', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 48 (n=0, 189, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-153.5', 'spread': '6.52', 'groupId': 'OG001'}, {'value': '-158.2', 'spread': '6.55', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 3mg vs Aflibercept 2mg) - Week 52 (n=190, 0, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-156.4', 'spread': '6.70', 'groupId': 'OG000'}, {'value': '-160.7', 'spread': '6.75', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 6mg vs Aflibercept 2mg) - Week 52 (n=0, 189, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-165.5', 'spread': '6.17', 'groupId': 'OG001'}, {'value': '-160.4', 'spread': '6.21', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-17.7', 'ciUpperLimit': '16.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.68', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-18.7', 'ciUpperLimit': '14.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.41', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.2', 'ciLowerLimit': '-5.2', 'ciUpperLimit': '29.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.87', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '-14.0', 'ciUpperLimit': '18.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.38', 'groupDescription': 'Week 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-16.0', 'ciUpperLimit': '17.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.61', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.4', 'ciLowerLimit': '-19.6', 'ciUpperLimit': '12.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.28', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.4', 'ciLowerLimit': '-10.7', 'ciUpperLimit': '23.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.73', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.8', 'ciLowerLimit': '-14.6', 'ciUpperLimit': '20.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.85', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-15.7', 'ciUpperLimit': '17.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.50', 'groupDescription': 'Week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.4', 'ciLowerLimit': '-19.7', 'ciUpperLimit': '12.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.29', 'groupDescription': 'Week 16', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.9', 'ciLowerLimit': '-8.6', 'ciUpperLimit': '26.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.92', 'groupDescription': 'Week 18', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '-14.1', 'ciUpperLimit': '19.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.47', 'groupDescription': 'Week 18', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.4', 'ciLowerLimit': '-20.2', 'ciUpperLimit': '13.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.55', 'groupDescription': 'Week 20', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.8', 'ciLowerLimit': '-21.7', 'ciUpperLimit': '10.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.12', 'groupDescription': 'Week 20', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.9', 'ciLowerLimit': '-31.7', 'ciUpperLimit': '3.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.06', 'groupDescription': 'Week 24', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.8', 'ciLowerLimit': '-35.4', 'ciUpperLimit': '-0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.95', 'groupDescription': 'Week 24', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.7', 'ciLowerLimit': '-25.0', 'ciUpperLimit': '7.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.26', 'groupDescription': 'Week 28', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.7', 'ciLowerLimit': '-25.4', 'ciUpperLimit': '8.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.49', 'groupDescription': 'Week 28', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.2', 'ciLowerLimit': '-21.8', 'ciUpperLimit': '15.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.49', 'groupDescription': 'Week 32', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.7', 'ciLowerLimit': '-29.5', 'ciUpperLimit': '6.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.02', 'groupDescription': 'Week 32', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36.3', 'ciLowerLimit': '14.6', 'ciUpperLimit': '57.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.01', 'groupDescription': 'Week 36', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.4', 'ciLowerLimit': '0.7', 'ciUpperLimit': '40.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.97', 'groupDescription': 'Week 36', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.1', 'ciLowerLimit': '-24.2', 'ciUpperLimit': '11.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.19', 'groupDescription': 'Week 40', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.5', 'ciLowerLimit': '-25.2', 'ciUpperLimit': '12.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.50', 'groupDescription': 'Week 40', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.9', 'ciLowerLimit': '-10.4', 'ciUpperLimit': '26.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.33', 'groupDescription': 'Week 44', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-16.2', 'ciUpperLimit': '18.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.78', 'groupDescription': 'Week 44', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.6', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '32.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.84', 'groupDescription': 'Week 48', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.7', 'ciLowerLimit': '-13.5', 'ciUpperLimit': '23.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.26', 'groupDescription': 'Week 48', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.3', 'ciLowerLimit': '-14.5', 'ciUpperLimit': '23.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.52', 'groupDescription': 'Week 52', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.1', 'ciLowerLimit': '-22.3', 'ciUpperLimit': '12.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.78', 'groupDescription': 'Week 52', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline up to week 52', 'description': 'Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.\n\nLS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.', 'unitOfMeasure': 'μm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - Last observation carried forward (LOCF)'}, {'type': 'SECONDARY', 'title': 'Central Subfield Thickness (CSFT) (Micrometers): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (Full Analysis Set - LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'LS mean estimate (Brolucizumab 3 mg vs Aflibercept 2 mg) (n=190, 0, 187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-167.1', 'spread': '6.54', 'groupId': 'OG000'}, {'value': '-168.8', 'spread': '6.59', 'groupId': 'OG002'}]}]}, {'title': 'LS mean estimate (Brolucizumab 6 mg vs Aflibercept 2 mg) (n=0, 189,187)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-171.9', 'spread': '6.18', 'groupId': 'OG001'}, {'value': '-168.5', 'spread': '6.22', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '-16.6', 'ciUpperLimit': '20.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.30', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.5', 'ciLowerLimit': '-20.7', 'ciUpperLimit': '13.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.79', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, and Week 88 through Week 100 (average)', 'description': 'Central subfield thickness (average thickness of circular 1mm area centered around fovea measured from RPE to ILM, inclusively). Assessed with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nLS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.', 'unitOfMeasure': 'micrometers', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set - LOCF'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Week16', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Week18', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Week 76', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Week 80', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Week 84', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Week 88', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Week 92', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Week 100', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 52 and Week 100', 'description': 'Subretinal Fluid (SRF) status in the central subfield: proportion of subjects with presence of SRF in the study eye by visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - Last observation carried forward (LOCF)'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '167', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '153', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}]}, {'title': 'Week 76', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}]}, {'title': 'Week 80', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}]}, {'title': 'Week 84', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}]}, {'title': 'Week 88', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}]}, {'title': 'Week 92', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}]}, {'title': 'Week 100', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, up to Week 52 and Week 100', 'description': 'Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of IRF in the study eye by visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - Last observation carried forward (LOCF)'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '169', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '153', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '153', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '135', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '137', 'groupId': 'OG002'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}]}, {'title': 'Week 76', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}]}, {'title': 'Week 80', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}]}, {'title': 'Week 84', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}]}, {'title': 'Week 88', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}]}]}, {'title': 'Week 92', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}]}, {'title': 'Week 100', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, up to Week 52 and Week 100', 'description': 'Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of SRF and/or IRF in the study eye by visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - Last observation carried forward (LOCF)'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '186', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 52', 'description': 'Assessed by angiography.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - Last observation carried forward (LOCF). The angiogram results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '186', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 100', 'description': 'Assessed by angiography.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - Last observation carried forward (LOCF). The angiogram results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality.'}, {'type': 'SECONDARY', 'title': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'Week 28', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': 'Week 76', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}]}, {'title': 'Week 100', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - Last observation carried forward (LOCF). The results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality.'}, {'type': 'SECONDARY', 'title': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 28 (n = 185,0, 184)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.3', 'groupId': 'OG000'}, {'value': '21.7', 'groupId': 'OG002'}]}]}, {'title': 'Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E.(%) at Week 28 (n = 0, 186, 184)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.8', 'groupId': 'OG001'}, {'value': '21.7', 'groupId': 'OG002'}]}]}, {'title': 'Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 52 (n = 185,0, 184)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000'}, {'value': '22.3', 'groupId': 'OG002'}]}]}, {'title': 'Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 52 (n = 0, 186, 184)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG001'}, {'value': '22.2', 'groupId': 'OG002'}]}]}, {'title': 'Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 76 (n = 185,0, 184)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.2', 'groupId': 'OG000'}, {'value': '28.4', 'groupId': 'OG002'}]}]}, {'title': 'Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E.(%) at Week 76 (n = 0, 186, 184)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG001'}, {'value': '28.3', 'groupId': 'OG002'}]}]}, {'title': 'Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 100 (n = 185,0, 184)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.7', 'groupId': 'OG000'}, {'value': '30.1', 'groupId': 'OG002'}]}]}, {'title': 'Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E.(%) at Week 100 (n = 0, 186, 184)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG001'}, {'value': '30.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '-5.3', 'ciUpperLimit': '8.4', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive; Week 28'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.1', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '10.3', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive; Week 28'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.8', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '12.4', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive; Week 52'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.7', 'ciLowerLimit': '0.6', 'ciUpperLimit': '12.9', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive; Week 52'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.8', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '9.4', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive: Week 76'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-5.7', 'ciUpperLimit': '7.0', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive: Week 76'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '-5.0', 'ciUpperLimit': '8.1', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive: Week 100'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '8.4', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive: Week 100'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.\n\n* estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.\n* estimates represent the % of participants who were estimated to have a "\\>=2-step Improvement From Baseline in the DRSS Score" from pairwise logistic regression models adjusting for baseline DRSS score categories (\\<=4, ≥5), age categories (\\<65, ≥65 years) and treatment as fixed effect factors.\n\nAbbreviation: Proportion Estimates = P.E.', 'unitOfMeasure': 'Percentage estimates', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - Last observation carried forward (LOCF). The results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality.'}, {'type': 'SECONDARY', 'title': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'Week 28', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'Week 76', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Week 100', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - Last observation carried forward (LOCF). The results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality.'}, {'type': 'SECONDARY', 'title': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 28 (n = 185, 0, 184)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000'}, {'value': '12.3', 'groupId': 'OG002'}]}]}, {'title': 'Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 28 (n = 0, 186, 184)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG001'}, {'value': '12.2', 'groupId': 'OG002'}]}]}, {'title': 'Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E.(%) at Week 52 (n = 185, 0, 184)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000'}, {'value': '16.8', 'groupId': 'OG002'}]}]}, {'title': 'Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 52 (n = 0, 186, 184)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG001'}, {'value': '16.7', 'groupId': 'OG002'}]}]}, {'title': 'Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 76 (n = 185, 0, 184)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.2', 'groupId': 'OG000'}, {'value': '23.4', 'groupId': 'OG002'}]}]}, {'title': 'Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 76 (n = 0, 186, 184)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG001'}, {'value': '23.3', 'groupId': 'OG002'}]}]}, {'title': 'Comparison of Brolucizumab 3 mg vs. Aflibercept 2 mg - P.E. (%) at Week 100 (n = 185, 0, 184)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000'}, {'value': '22.9', 'groupId': 'OG002'}]}]}, {'title': 'Comparison of Brolucizumab 6 mg vs. Aflibercept 2 mg - P.E. (%) at Week 100 (n = 0, 186, 184)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.2', 'groupId': 'OG001'}, {'value': '22.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-6.4', 'ciUpperLimit': '5.8', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive; Week 28'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.6', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '11.0', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive; Week 28'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.2', 'ciLowerLimit': '-10.2', 'ciUpperLimit': '2.2', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive; Week 52'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.9', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '10.5', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive; Week 52'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.2', 'ciLowerLimit': '-15.5', 'ciUpperLimit': '-2.8', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive; Week 72'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-8.4', 'ciUpperLimit': '4.4', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive; Week 72'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.7', 'ciLowerLimit': '-14.0', 'ciUpperLimit': '-1.6', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive; Week 100'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference - %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-5.7', 'ciUpperLimit': '6.8', 'statisticalMethod': 'Bootstrap method', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive; Week 100'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.\n\n* estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.\n* estimates represent the % of participants who were estimated to have a "\\>=3-step Improvement From Baseline in the DRSS Score" from pairwise logistic regression models adjusting for baseline DRSS score categories (\\<=4, ≥5), age categories (\\<65, ≥65 years) and treatment as fixed effect factors.\n\nAbbreviation: Proportion Estimates = P.E.', 'unitOfMeasure': 'Percentage estimates', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - Last observation carried forward (LOCF). The results are not available at baseline on all participants because in rare cases, the images could not be read e.g., because of poor quality.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '11.89', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '14.27', 'groupId': 'OG001'}, {'value': '7.8', 'spread': '12.68', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 (n = 151,148,157)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '12.89', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '13.24', 'groupId': 'OG001'}, {'value': '8.5', 'spread': '12.99', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (n = 133,138,143)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '13.21', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '14.50', 'groupId': 'OG001'}, {'value': '7.1', 'spread': '12.49', 'groupId': 'OG002'}]}]}, {'title': 'Week 100 (n=140,141,142)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.6', 'spread': '15.16', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '14.41', 'groupId': 'OG001'}, {'value': '6.2', 'spread': '13.16', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'overall scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - Observed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '14.75', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '18.11', 'groupId': 'OG001'}, {'value': '11.3', 'spread': '15.88', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 (n = 151,148,157)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.6', 'spread': '14.74', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '17.18', 'groupId': 'OG001'}, {'value': '10.7', 'spread': '17.62', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (n = 133,138,143)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': '14.89', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '17.80', 'groupId': 'OG001'}, {'value': '11.7', 'spread': '17.97', 'groupId': 'OG002'}]}]}, {'title': 'Week 100 (n=140,141,142)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.4', 'spread': '17.87', 'groupId': 'OG000'}, {'value': '13.5', 'spread': '17.97', 'groupId': 'OG001'}, {'value': '11.5', 'spread': '16.21', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'overall scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - Observed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '21.02', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '21.92', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '23.61', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 (n = 151,148,157)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '19.55', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '19.54', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '22.16', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (n = 133,138,143)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '19.75', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '22.78', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '21.72', 'groupId': 'OG002'}]}]}, {'title': 'Week 100 (n=140,141,142)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '19.90', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '18.37', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '19.73', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'overall scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - Observed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.4', 'spread': '19.83', 'groupId': 'OG000'}, {'value': '13.2', 'spread': '24.93', 'groupId': 'OG001'}, {'value': '13.7', 'spread': '20.51', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 (n = 151,148,157)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '21.41', 'groupId': 'OG000'}, {'value': '14.1', 'spread': '24.17', 'groupId': 'OG001'}, {'value': '13.4', 'spread': '23.64', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (n = 133,138,143)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.7', 'spread': '20.00', 'groupId': 'OG000'}, {'value': '14.9', 'spread': '23.35', 'groupId': 'OG001'}, {'value': '12.4', 'spread': '20.92', 'groupId': 'OG002'}]}]}, {'title': 'Week 100 (n=140,141,142)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.6', 'spread': '22.23', 'groupId': 'OG000'}, {'value': '15.7', 'spread': '22.01', 'groupId': 'OG001'}, {'value': '10.4', 'spread': '23.50', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'overall scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - Observed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '18.39', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '21.58', 'groupId': 'OG001'}, {'value': '9.0', 'spread': '19.35', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 (n = 151,148,157)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '22.20', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '19.42', 'groupId': 'OG001'}, {'value': '9.9', 'spread': '20.05', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (n = 133,138,143)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.3', 'spread': '20.45', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '19.20', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '18.39', 'groupId': 'OG002'}]}]}, {'title': 'Week 100 (n=140,141,142)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.4', 'spread': '20.68', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '19.24', 'groupId': 'OG001'}, {'value': '6.7', 'spread': '19.15', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'overall scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - Observed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '17.79', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '18.00', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '14.15', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 (n = 151,148,157)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '18.82', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '17.53', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '15.98', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (n = 133,138,143)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '17.24', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '18.95', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '16.49', 'groupId': 'OG002'}]}]}, {'title': 'Week 100 (n=140,141,142)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '19.68', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '21.82', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '16.38', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'overall scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - Observed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '20.63', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '22.21', 'groupId': 'OG001'}, {'value': '8.7', 'spread': '19.71', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 (n = 151,148,157)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.9', 'spread': '22.93', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '21.42', 'groupId': 'OG001'}, {'value': '11.3', 'spread': '21.34', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (n = 133,138,143)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.3', 'spread': '21.07', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '21.10', 'groupId': 'OG001'}, {'value': '11.2', 'spread': '20.93', 'groupId': 'OG002'}]}]}, {'title': 'Week 100 (n=140,141,142)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.7', 'spread': '25.28', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '23.62', 'groupId': 'OG001'}, {'value': '10.9', 'spread': '22.22', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'overall scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - Observed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.0', 'spread': '24.93', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '26.81', 'groupId': 'OG001'}, {'value': '9.4', 'spread': '27.34', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 (n = 151,148,157)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '23.88', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '29.11', 'groupId': 'OG001'}, {'value': '11.3', 'spread': '25.47', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (n = 133,138,143)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.9', 'spread': '25.10', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '29.48', 'groupId': 'OG001'}, {'value': '7.4', 'spread': '27.76', 'groupId': 'OG002'}]}]}, {'title': 'Week 100 (n=140,141,142)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.3', 'spread': '28.27', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '28.88', 'groupId': 'OG001'}, {'value': '6.9', 'spread': '26.19', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'overall scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - Observed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': '21.80', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '25.16', 'groupId': 'OG001'}, {'value': '7.1', 'spread': '22.06', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 (n = 151,148,157)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '23.05', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '25.36', 'groupId': 'OG001'}, {'value': '9.0', 'spread': '22.68', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (n = 133,138,143)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '22.93', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '25.56', 'groupId': 'OG001'}, {'value': '6.8', 'spread': '22.59', 'groupId': 'OG002'}]}]}, {'title': 'Week 100 (n=140,141,142)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '24.89', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '25.79', 'groupId': 'OG001'}, {'value': '5.6', 'spread': '25.35', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'overall scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - Observed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '16.40', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '17.74', 'groupId': 'OG001'}, {'value': '6.7', 'spread': '15.06', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 (n = 97,98,91)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '16.51', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '18.73', 'groupId': 'OG001'}, {'value': '6.4', 'spread': '17.64', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (n = 86,86,83)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '16.09', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '18.34', 'groupId': 'OG001'}, {'value': '6.5', 'spread': '19.13', 'groupId': 'OG002'}]}]}, {'title': 'Week 100 (n=86,86,81)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.2', 'spread': '16.58', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '20.24', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '18.84', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'overall scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - Observed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '14.37', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '18.20', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '14.49', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 (n = 148,147,152)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '16.11', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '12.59', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '15.13', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (n = 131,137,140)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '13.58', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '17.01', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '13.90', 'groupId': 'OG002'}]}]}, {'title': 'Week 100 (n=139,138,138)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '14.14', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '15.79', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '16.94', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. 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All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.', 'unitOfMeasure': 'overall scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS - Observed'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG001', 'title': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule'}, {'id': 'OG002', 'title': 'Aflibercept 2 mg', 'description': 'Aflibercept 2 mg/0.05 mL, as labeled, 5 loading doses, with subsequent doses every 8 weeks'}], 'classes': [{'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '19.50', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '22.10', 'groupId': 'OG001'}, {'value': '6.1', 'spread': '19.25', 'groupId': 'OG002'}]}]}, {'title': 'Week 52 (n = 151,148,157)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '22.50', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '22.32', 'groupId': 'OG001'}, {'value': '6.8', 'spread': '24.94', 'groupId': 'OG002'}]}]}, {'title': 'Week 76 (n = 133, 138, 143)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '23.53', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '24.18', 'groupId': 'OG001'}, {'value': '8.2', 'spread': '20.93', 'groupId': 'OG002'}]}]}, {'title': 'Week 100 (n=140, 141, 142)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}, {'value': '142', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '23.97', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '23.55', 'groupId': 'OG001'}, {'value': '8.8', 'spread': '21.72', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. 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'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '461', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-28', 'size': 1958826, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-05-27T16:07', 'hasProtocol': True}, {'date': '2020-11-26', 'size': 1392449, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-07-07T13:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 566}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'dispFirstSubmitDate': '2021-01-06', 'completionDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-27', 'studyFirstSubmitDate': '2018-03-13', 'dispFirstSubmitQcDate': '2022-10-03', 'resultsFirstSubmitDate': '2022-05-27', 'studyFirstSubmitQcDate': '2018-03-27', 'dispFirstPostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-03', 'studyFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual Function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.\n\nThis endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept.'}], 'secondaryOutcomes': [{'measure': 'Average Change From Baseline in BCVA Over the Period Week 40 Through Week 52', 'timeFrame': 'Baseline and Week 40 through Week 52 (average)', 'description': 'BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (per the inclusion criteria) (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.\n\nThis endpoint was analyzed via the pairwise ANOVA method where the 2 dose groups of Brolucizumab are compared to Aflibercept.'}, {'measure': 'Patients Maintained at q12w - Probability of Maintaining on q12w', 'timeFrame': 'Baseline (Week 0), Weeks 32, 36 and 48', 'description': 'Positive treatment status is defined as intravitreal (IVT) injections per planned dosing regimen \\[every 12 weeks (q12w)\\]. This outcome measure is pre-specified for brolucizumab treatment arms only.'}, {'measure': 'Patients Maintained at q12w (for Those Patients Who Qualified for q12w at Week 36) - Probability of Maintaining on q12w', 'timeFrame': 'Weeks 36 and 48', 'description': 'Positive treatment status is defined as intravitreal (IVT) injections per planned dosing regimen \\[every 8 weeks (q8w)\\]. This outcome measure is pre-specified for brolucizumab treatment arms only.'}, {'measure': 'Change From Baseline in BCVA at Each Visit up to Week 52', 'timeFrame': 'Baseline (Week 0), Weeks 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, and 52', 'description': 'BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nVisual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye were included.\n\nMin and max possible scores are 0-100 respectively. A higher score represents better visual functioning.'}, {'measure': 'BCVA (Letters Read): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (FAS - LOCF)', 'timeFrame': 'Baseline, and Week 88 through Week 100 (average)', 'description': 'Visual acuity was assessed at every study visit using best correction determined from protocol refraction (BCVA). BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts.\n\nLS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.'}, {'measure': 'Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100 - Probability of Maintaining on q12w', 'timeFrame': 'Baseline (Week 0), Weeks 32, 36, 48, 60, 72, 84, and 96', 'description': 'This outcome measure is pre-specified for brolucizumab treatment arms only'}, {'measure': 'Secondary: Patients Maintained at q12w up to Week 64 (After Three q12w- Treatment Intervals) and Week 100, Within Those Patients That Qualified for q12w at Week 36 - Probability of Maintaining on q12w', 'timeFrame': 'Baseline (Week 0), Weeks 32, 36, 48, 60, 72, 84, and 96', 'description': 'This outcome measure is pre-specified for brolucizumab treatment arms only'}, {'measure': 'Change From Baseline in Central Subfield Thickness (CSFT) at Each Visit up to Week 52 - Pairwise ANOVA Results', 'timeFrame': 'Baseline up to week 52', 'description': 'Central Subfield Thickness Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.\n\nLS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.'}, {'measure': 'Central Subfield Thickness (CSFT) (Micrometers): ANOVA Results for Average Change From Baseline Over the Period Week 88 Through Week 100 for the Study Eye (Full Analysis Set - LOCF)', 'timeFrame': 'Baseline, and Week 88 through Week 100 (average)', 'description': 'Central subfield thickness (average thickness of circular 1mm area centered around fovea measured from RPE to ILM, inclusively). Assessed with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.\n\nLS Mean estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.'}, {'measure': 'Number of Patients With Presence of Subretinal Fluid (SRF) at Each Assessment Visit', 'timeFrame': 'Baseline up to Week 52 and Week 100', 'description': 'Subretinal Fluid (SRF) status in the central subfield: proportion of subjects with presence of SRF in the study eye by visit'}, {'measure': 'Number of Patients With Presence of Intraretinal Fluid (IRF) at Each Assessment Visit', 'timeFrame': 'Baseline, up to Week 52 and Week 100', 'description': 'Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of IRF in the study eye by visit'}, {'measure': 'Number of Patients With Presence of SRF and/or IRF in the Study Eye by Visit', 'timeFrame': 'Baseline, up to Week 52 and Week 100', 'description': 'Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) status in the central subfield: proportion of subjects with presence of SRF and/or IRF in the study eye by visit'}, {'measure': 'Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 52', 'timeFrame': 'Week 52', 'description': 'Assessed by angiography.'}, {'measure': 'Number of Patients With Presence of Leakage on Fluorescein Angiography (FA) at Week 100', 'timeFrame': 'Week 100', 'description': 'Assessed by angiography.'}, {'measure': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.'}, {'measure': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=2-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.\n\n* estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.\n* estimates represent the % of participants who were estimated to have a "\\>=2-step Improvement From Baseline in the DRSS Score" from pairwise logistic regression models adjusting for baseline DRSS score categories (\\<=4, ≥5), age categories (\\<65, ≥65 years) and treatment as fixed effect factors.\n\nAbbreviation: Proportion Estimates = P.E.'}, {'measure': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Number of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Number of Subjects', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.'}, {'measure': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS): Proportion of Subjects With >=3-step Improvement From Baseline in the DRSS Score at Each Assessment Visit for the Study Eye - Percentage Estimates', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'Severity of Diabetic Retinopathy (DR) was evaluated using the ETDRS DRSS score assessed by the Central Reading Center (CRC) based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on a 12-level scale, from 1 (DR absent) to 12 (very advanced PDR). A lower score represents better visual functioning.\n\n* estimates are reported, comparing the 2 Brolucizumab arms to Aflibercept. Results do not apply to the Brolucizumab 6 mg arm when Brolucizumab 3mg is compared to Aflibercept. Likewise, results do not apply to the Brolucizumab 3 mg arm when Brolucizumab 6 mg is compared to Aflibercept.\n* estimates represent the % of participants who were estimated to have a "\\>=3-step Improvement From Baseline in the DRSS Score" from pairwise logistic regression models adjusting for baseline DRSS score categories (\\<=4, ≥5), age categories (\\<65, ≥65 years) and treatment as fixed effect factors.\n\nAbbreviation: Proportion Estimates = P.E.'}, {'measure': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Composite Score', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Vision', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Ocular Pain', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Near Activities', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Distance Activities', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Social Functioning', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Mental Health', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Role Difficulties', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Dependency', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Driving', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Color Vision', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - Peripheral Vision', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Change From Baseline in Patient Reported Outcomes Visual Functioning Questionnaire-25 (VFQ-25) Total Scores up to Week 52 and Week 100 - General Health Rating', 'timeFrame': 'Baseline, Weeks 28, 52, 76, 100', 'description': 'The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) measures the influence of visual disability and visual symptoms on general health domains.\n\nThe NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better visual functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. A composite score is derived based on the average of the 11 subscales.'}, {'measure': 'Ocular Adverse Events (AEs) (>=2% in Any Treatment Arm) by Preferred Term for the Study Eye', 'timeFrame': 'Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.'}, {'measure': 'Number of Subjects With Non-ocular Adverse Events (AEs) (>=2% in Any Treatment Arm)', 'timeFrame': 'Adverse events were reported from first dose of study treatment until Week 96, plus 30 days post treatment, up to a maximum duration of 100 weeks.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetic Macular Edema', 'intravitreal injection', 'brolucizumab', 'aflibercept', 'double-masked', 'Diabetic Macular Edema (DME)', 'macular edema', 'diabetic retinopathy'], 'conditions': ['Diabetic Macular Edema']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1194', 'label': 'A Plain Language Trial Summary is available on novctrd.com'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).', 'detailedDescription': 'This was a Phase III, randomized, double-masked, multi-center, active-controlled, three-arm study designed to evaluate the efficacy and safety of brolucizumab 6 mg and 3 mg compared to the active control, aflibercept 2 mg used per authorized label, in subjects with diabetic macular edema (DME). The study included a screening period of up to 2 weeks to assess eligibility, followed by a doublemasked treatment period (Day 1 to Week 96). The baseline visit was defined as Day 1/Visit 1, and end of treatment visit as Visit 27 (Week 96). After the last treatment visit, a post-treatment follow-up period was planned from Week 96 to Week 100.\n\nSubjects were assigned to one of three treatment arms in a 1:1:1 ratio: brolucizumab 6 mg/0.05 mL administered 5 x every 6 weeks (q6w) during loading phase then q12w/every 8 weeks (q8w) during maintenance phase, brolucizumab 3 mg/0.05 mL administered 5 x every 6 weeks (q6w) during loading phase then q12w/q8w during maintenance phase or aflibercept 2 mg/0.05 mL administered 5 x every 4 weeks (q4w) during loading phase then q8w during maintenance phase.\n\nDisease Activity Assessments (DAAs) were conducted by the masked investigator for each treatment arm at Week 32 and Week 36, i.e. 8 and 12 weeks after the end of the loading phase for subjects receiving brolucizumab. Assessments were also performed at Week 48, and will then continue to be performed from Week 60 up to Week 96, every 12 weeks. Subjects in the brolucizumab arms who qualified for q12w during the initial q12w interval continued on a q12w treatment frequency unless disease activity was identified at any of the subsequent DAA visits, in which case subjects were switched to a q8w treatment interval until the end of the study.\n\nTo fulfil the double-masking requirement, each investigational site had masked and unmasked staff. The investigator who performed the injection was unmasked to the treatments as were any other site personnel who had been delegated responsibility for working with the Investigational Product (IP). The unmasked site personnel and unmasked injecting investigator did not perform Best-corrected visual acuity (BCVA), complete ophthalmic examination (with the exception of post-injection safety assessment), DAAs or administer the Visual Functioning Questionnaire-25 (VFQ-25). Also, the unmasked site personnel and unmasked injecting physician did not perform assessment of any ocular or non-ocular safety parameters, or assess causality of Adverse event (AEs) for subjects during the course of the study except an event reported immediately following Intravitreal treatment (IVT). Once the designated roles were determined, the unmasked investigator/site personnel roles were not switched at any time after randomization to masked role. Every effort was made to limit the number of unmasked study personnel to ensure the integrity of this masked study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent before any assessment\n* Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening\n* Medication for the management of diabetes stable within 3 months prior to randomization and is expected to remain stable during the course of the study\n\nExclusion Criteria:\n\n* Active proliferative diabetic retinopathy in the study eye\n* Active intraocular or periocular infection or active intraocular inflammation in study eye\n* Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) \\> 25 millimeters mercury (mmHg)\n* Previous treatment with anti-VEGF drugs or investigational drugs in the study eye\n* Stroke or myocardial infarction during the 6-month period prior to baseline\n* Uncontrolled blood pressure defined as a systolic value ≥160 mmHg or diastolic value ≥100 mmHg\n\nOther protocol-specified inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT03481634', 'acronym': 'KESTREL', 'briefTitle': 'Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Two-year, Three-arm, Randomized, Double-masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Diabetic Macular Edema', 'orgStudyIdInfo': {'id': 'CRTH258B2301'}, 'secondaryIdInfos': [{'id': '2017-004742-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brolucizumab 3 mg', 'description': 'Brolucizumab 3 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule.\n\nTo fulfil the double-masking requirement, each investigational site had masked and unmasked staff. The investigator who performed the injection was unmasked to the treatments as were any other site personnel who had been delegated responsibility for working with the Investigational Product (IP).', 'interventionNames': ['Drug: Brolucizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Brolucizumab 6 mg', 'description': 'Brolucizumab 6 mg/0.05 mL, 5 loading doses, with subsequent doses per protocol-specified maintenance schedule.\n\nTo fulfil the double-masking requirement, each investigational site had masked and unmasked staff. 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