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Ignite Creation Date: 2025-12-24 @ 7:38 PM

Ignite Modification Date: 2025-12-28 @ 3:30 AM

Study NCT ID: NCT04429503

Status: COMPLETED

Last Update Posted: 2025-08-08

First Post: 2020-05-26

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease

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': '2023-08-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533178', 'term': 'aflibercept'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@regeneron.com', 'phone': '844-734-6643', 'title': 'Clinical Trials Administrator', 'organization': 'Regeneron Pharmaceuticals, Inc'}, 'certainAgreement': {'otherDetails': "The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first study treatment through week 156', 'eventGroups': [{'id': 'EG000', 'title': 'Aflibercept 2 mg Every 8 Weeks (2q8)', 'description': '(baseline through week 96)', 'otherNumAtRisk': 167, 'deathsNumAtRisk': 167, 'otherNumAffected': 98, 'seriousNumAtRisk': 167, 'deathsNumAffected': 9, 'seriousNumAffected': 46}, {'id': 'EG001', 'title': 'HD Aflibercept Every 12 Weeks (HDq12)', 'description': '(baseline through week 96)', 'otherNumAtRisk': 328, 'deathsNumAtRisk': 328, 'otherNumAffected': 190, 'seriousNumAtRisk': 328, 'deathsNumAffected': 18, 'seriousNumAffected': 84}, {'id': 'EG002', 'title': 'HD Aflibercept Every 16 Weeks (HDq16)', 'description': '(baseline through week 96)', 'otherNumAtRisk': 163, 'deathsNumAtRisk': 163, 'otherNumAffected': 116, 'seriousNumAtRisk': 163, 'deathsNumAffected': 5, 'seriousNumAffected': 45}, {'id': 'EG003', 'title': '2q8/HD Aflibercept (Extension)', 'description': 'Participants receiving aflibercept 2q8 switched to HD in the extension phase (week 96 through week 156)', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 50, 'seriousNumAtRisk': 70, 'deathsNumAffected': 2, 'seriousNumAffected': 27}, {'id': 'EG004', 'title': 'HDq12 Aflibercept (Extension)', 'description': 'Participants continued to receive HDq12 aflibercept during the extension phase (week 96 through 156)', 'otherNumAtRisk': 130, 'deathsNumAtRisk': 130, 'otherNumAffected': 99, 'seriousNumAtRisk': 130, 'deathsNumAffected': 7, 'seriousNumAffected': 46}, {'id': 'EG005', 'title': 'HDq16 Aflibercept (Extension)', 'description': 'Participants continued to receive HDq16 aflibercept during the extension phase (week 96 through 156)', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 50, 'seriousNumAtRisk': 65, 'deathsNumAffected': 3, 'seriousNumAffected': 23}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 41, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 27, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 31, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 38, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 34, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Cataract Fellow Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Cataract Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Vitreous floaters Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 24, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Conjunctival haemorrhage Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Eye pain Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Punctate keratitis Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Retinal haemorrhage Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Vision blurred Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Visual acuity reduced Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Visual impairment Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Vitreous detachment Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Intraocular pressure increased Study Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 15, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Diabetic retinal oedema Fellow Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Punctate keratitis Fellow Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Vitreous detachment Fellow Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Vitreous floaters Fellow Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Vitreous haemorrhage Fellow Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Diabetic retinopathy Fellow Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 163, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 167, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 328, 'numEvents': 5, 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Every 12 Weeks (HDq12)', 'description': 'Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses'}, {'id': 'OG002', 'title': 'HD Aflibercept Every 16 Weeks (HDq16)', 'description': 'Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '8.67', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '8.10', 'spread': '0.61', 'groupId': 'OG001'}, {'value': '7.23', 'spread': '0.71', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-2.26', 'ciUpperLimit': '1.13', 'estimateComment': 'HDq12 minus 2q8', 'statisticalMethod': 'Mixed Model for Repeated Measurements', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'p-value for one-sided non-inferiority (NI) test at a margin of 4 letters'}, {'pValue': '0.0031', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.44', 'ciLowerLimit': '-3.27', 'ciUpperLimit': '0.39', 'estimateComment': 'HDq16 minus 2q8', 'statisticalMethod': 'Mixed Model for Repeated Measurements', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'p-value for one-sided non-inferiority (NI) test at a margin of 4 letters'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 48', 'description': 'Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized); Only one study eye per participant was analyzed within the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a ≥2 Step Improvement From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Score at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2 mg Every 8 Weeks (2q8)', 'description': 'Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses'}, {'id': 'OG001', 'title': 'High-dose (HD) Aflibercept Every 12 Weeks (HDq12)', 'description': 'Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses'}, {'id': 'OG002', 'title': 'HD Aflibercept Every 16 Weeks (HDq16)', 'description': 'Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000'}, {'value': '29.0', 'groupId': 'OG001'}, {'value': '19.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.98', 'ciLowerLimit': '-6.61', 'ciUpperLimit': '10.57', 'estimateComment': 'Difference with confidence interval (CI) was calculated using Mantel-Haenszel weighting scheme adjusted for stratification factors', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority margin was set at 15%'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.52', 'ciLowerLimit': '-16.88', 'ciUpperLimit': '1.84', 'estimateComment': 'Difference with confidence interval (CI) was calculated using Mantel-Haenszel weighting scheme adjusted for stratification factors', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority margin was set at 15%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 48', 'description': 'The DRSS was assessed according to the following scale: 10 = Diabetic retinopathy (DR) absent, 14 = DR questionable, 15 = DR questionable, 20 = Micro-aneurysms only, 35 = Mild Non-proliferative diabetic retinopathy (NPDR), 43 = Moderate NPDR, 47 = Moderately severe NPDR, 53 = Severe NPDR, 61 = Mild Proliferative diabetic retinopathy (PDR), 65 = Moderate PDR, 71 = High-risk PDR, 75 = High-risk PDR, 81 = Advanced PDR: fundus partially obscured, center of macula attached, 85 = Advanced PDR: posterior fundus obscured, or center of macula detached, 90 = cannot grade, even sufficiently for level 81 or 85.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized); Only one study eye per participant was analyzed within the study,'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2 mg Every 8 Weeks (2q8)', 'description': 'Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses'}, {'id': 'OG001', 'title': 'High-dose (HD) Aflibercept Every 12 Weeks (HDq12)', 'description': 'Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses'}, {'id': 'OG002', 'title': 'HD Aflibercept Every 16 Weeks (HDq16)', 'description': 'Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000'}, {'value': '18.7', 'groupId': 'OG001'}, {'value': '16.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 48', 'description': 'Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best). Only one study eye per participant was analyzed within the study', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With BCVA ≥69 Letters at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2 mg Every 8 Weeks (2q8)', 'description': 'Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses'}, {'id': 'OG001', 'title': 'High-dose (HD) Aflibercept Every 12 Weeks (HDq12)', 'description': 'Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses'}, {'id': 'OG002', 'title': 'HD Aflibercept Every 16 Weeks (HDq16)', 'description': 'Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'groupId': 'OG000'}, {'value': '65.3', 'groupId': 'OG001'}, {'value': '62.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 48', 'description': 'Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized); Only one study eye per participant was analyzed within the study,'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Without Fluid at Foveal Center at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}, {'value': '162', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2 mg Every 8 Weeks (2q8)', 'description': 'Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses'}, {'id': 'OG001', 'title': 'High-dose (HD) Aflibercept Every 12 Weeks (HDq12)', 'description': 'Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses'}, {'id': 'OG002', 'title': 'HD Aflibercept Every 16 Weeks (HDq16)', 'description': 'Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000'}, {'value': '58.5', 'groupId': 'OG001'}, {'value': '43.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 48', 'description': 'Retinal fluid status was evaluated using spectral domain optical coherence tomography (SD-OCT) on the study eye.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '328', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2 mg Every 8 Weeks (2q8)', 'description': 'Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses'}, {'id': 'OG001', 'title': 'High-dose (HD) Aflibercept Every 12 Weeks (HDq12)', 'description': 'Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses'}, {'id': 'OG002', 'title': 'HD Aflibercept Every 16 Weeks (HDq16)', 'description': 'Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '-164.85', 'spread': '8.79', 'groupId': 'OG000'}, {'value': '-176.77', 'spread': '5.73', 'groupId': 'OG001'}, {'value': '-148.84', 'spread': '9.45', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 48', 'description': 'Central Retinal Thickness (CRT) was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).', 'unitOfMeasure': 'Microns', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized). Only one study eye per participant was analyzed within the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Without Leakage on Fluorescein Angiography (FA) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2 mg Every 8 Weeks (2q8)', 'description': 'Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses'}, {'id': 'OG001', 'title': 'High-dose (HD) Aflibercept Every 12 Weeks (HDq12)', 'description': 'Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses'}, {'id': 'OG002', 'title': 'HD Aflibercept Every 16 Weeks (HDq16)', 'description': 'Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '7.6', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 48', 'description': 'Leakage is the release of fluorescein dye from diseased retinal vessels.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Total Score at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '328', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2 mg Every 8 Weeks (2q8)', 'description': 'Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses'}, {'id': 'OG001', 'title': 'High-dose (HD) Aflibercept Every 12 Weeks (HDq12)', 'description': 'Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses'}, {'id': 'OG002', 'title': 'HD Aflibercept Every 16 Weeks (HDq16)', 'description': 'Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '2.82', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '4.06', 'spread': '0.80', 'groupId': 'OG001'}, {'value': '2.94', 'spread': '0.93', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 48', 'description': 'Vision-specific quality of life is assessed with the NEI VFQ-25 (National Eye Institute Visual Function Questionnaire), i.e. a 25-item questionnaire that gives a score on a scale from 0 (worst) to 100 (best = no vision problems).', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized)'}, {'type': 'SECONDARY', 'title': 'Systemic Pharmacokinetics (PK) of Aflibercept as Assessed by Plasma Concentrations Through Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '328', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2 mg Every 8 Weeks (2q8)', 'description': 'Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses'}, {'id': 'OG001', 'title': 'High-dose (HD) Aflibercept Every 12 Weeks (HDq12)', 'description': 'Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses'}, {'id': 'OG002', 'title': 'HD Aflibercept Every 16 Weeks (HDq16)', 'description': 'Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00102', 'spread': '0.00580', 'groupId': 'OG000'}, {'value': '0.0111', 'spread': '0.0157', 'groupId': 'OG001'}, {'value': '0.00105', 'spread': '0.00477', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through Week 48', 'description': 'Concentrations of Free Aflibercept in Plasma by Time and Treatment Group', 'unitOfMeasure': 'milligram/Litre (mg/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PKAS): All treated participants who received any amount of study drug and had at least 1 non-missing free or bound aflibercept measurement following the first dose of study drug as applicable. The PKAS is based on the actual treatment received (as treated) rather than as randomized.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BCVA in the Study Eye in Participants With Both Baseline and Week 48 BCVA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2 mg Every 8 Weeks (2q8)', 'description': 'Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses'}, {'id': 'OG001', 'title': 'High-dose (HD) Aflibercept Every 12 Weeks (HDq12)', 'description': 'Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses'}, {'id': 'OG002', 'title': 'HD Aflibercept Every 16 Weeks (HDq16)', 'description': 'Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '9.11', 'spread': '8.94', 'groupId': 'OG000'}, {'value': '9.14', 'spread': '8.35', 'groupId': 'OG001'}, {'value': '9.11', 'spread': '7.30', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'description': 'Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best). (Per Statistical Analysis Plan (SAP) Version 2.0 Appendix 10.9 for US Only)', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - for participants who had both baseline BCVA and week 48 BCVA; Only one study eye per participant was analyzed within the study'}, {'type': 'SECONDARY', 'title': 'Change From 8-weeks Post Initial Treatment Phase in BCVA in the Study Eye in Participants With Both 8-weeks Post Initial Treatment Phase BCVA and Week 48 BCVA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2 mg Every 8 Weeks (2q8)', 'description': 'Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses'}, {'id': 'OG001', 'title': 'High-dose (HD) Aflibercept Every 12 Weeks (HDq12)', 'description': 'Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses'}, {'id': 'OG002', 'title': 'HD Aflibercept Every 16 Weeks (HDq16)', 'description': 'Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '1.63', 'spread': '6.65', 'groupId': 'OG000'}, {'value': '1.68', 'spread': '5.54', 'groupId': 'OG001'}, {'value': '1.64', 'spread': '4.75', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48', 'description': 'Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best). (Per SAP Version 2.0 Appendix 10.9 for US Only)', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - for participants who had both BCVA at 8 weeks post initial treatment and week 48 BCVA; Only one study eye per participant was analyzed within the study'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BCVA (Region-specific Analysis) in the Study Eye at Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '328', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2 mg Every 8 Weeks (2q8)', 'description': 'Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses'}, {'id': 'OG001', 'title': 'High-dose (HD) Aflibercept Every 12 Weeks (HDq12)', 'description': 'Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses'}, {'id': 'OG002', 'title': 'HD Aflibercept Every 16 Weeks (HDq16)', 'description': 'Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '9.40', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '8.52', 'spread': '0.63', 'groupId': 'OG001'}, {'value': '7.64', 'spread': '0.75', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 60', 'description': 'Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS: All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized); Here, Number of Participants Analyzed = Number of participants with week 60 data. Only one study eye per participant was analyzed within the study'}, {'type': 'SECONDARY', 'title': 'Assessment of Immunogenicity to Aflibercept by Measuring the Incidence of Treatment-emergent Anti-drug Antibodies (ADA) Response Through Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2 mg Every 8 Weeks (2q8)', 'description': 'Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses'}, {'id': 'OG001', 'title': 'High-dose (HD) Aflibercept Every 12 Weeks (HDq12)', 'description': 'Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses'}, {'id': 'OG002', 'title': 'HD Aflibercept Every 16 Weeks (HDq16)', 'description': 'Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses'}], 'classes': [{'title': 'Pre-existing Immunoreactivity', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-Emergent', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Week 96', 'description': 'Number of participants with pre-existing immunoreactivity and treatment-emergent ADA response reported', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ADA analysis set (AAS): All treated participants who received any amount of study drug and had at least 1 non-missing anti-aflibercept antibody result following the first dose of study drug. The AAS is based on the actual treatment received (as treated) rather than as randomized'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Through Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '328', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2 mg Every 8 Weeks (2q8)', 'description': 'Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses'}, {'id': 'OG001', 'title': 'High-dose (HD) Aflibercept Every 12 Weeks (HDq12)', 'description': 'Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses'}, {'id': 'OG002', 'title': 'HD Aflibercept Every 16 Weeks (HDq16)', 'description': 'Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Week 96', 'description': 'A TEAE is an AE starting after the first dose of study drug to the last dose of study drug (active or sham) plus 30 days. Additionally, for patients who are still participating in the study (ie, have not been withdrawn and are continuing in the extension phase of the study) as of the week 96 visit all AEs up through the date of the week 96 visit were considered treatment-emergent.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAF): All randomized participants who received any study treatment; it was based on the treatment received (as treated)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Serious TEAE Through Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '328', 'groupId': 'OG001'}, {'value': '163', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2 mg Every 8 Weeks (2q8)', 'description': 'Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses'}, {'id': 'OG001', 'title': 'High-dose (HD) Aflibercept Every 12 Weeks (HDq12)', 'description': 'Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses'}, {'id': 'OG002', 'title': 'HD Aflibercept Every 16 Weeks (HDq16)', 'description': 'Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Week 96', 'description': 'A TEAE is an AE starting after the first dose of study drug to the last dose of study drug (active or sham) plus 30 days. Additionally, for patients who are still participating in the study (ie, have not been withdrawn and are continuing in the extension phase of the study) as of the week 96 visit all AEs up through the date of the week 96 visit were considered treatment-emergent.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAF): All randomized participants who received any study treatment; it was based on the treatment received (as treated)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any TEAE Through Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2q8/HD Aflibercept (Extension)', 'description': 'Participants receiving aflibercept 2q8 switched to HD in the extension phase'}, {'id': 'OG001', 'title': 'HDq12 Aflibercept (Extension)', 'description': 'Participants continued to receive HDq12 aflibercept during the extension phase'}, {'id': 'OG002', 'title': 'HDq16 Aflibercept (Extension)', 'description': 'Participants continued to receive HDq16 aflibercept during the extension phase'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Week 156', 'description': 'TEAEs are defined as AEs starting after the first dose of study drug to the last dose of study drug (active or sham) plus 30 days or week 156 visit, whichever was later.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Safety Analysis Set (eSAF): All participants in the SAF who enrolled in the extension phase and completed the extension baseline visit.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Serious TEAE Through Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '2q8/HD Aflibercept (Extension)', 'description': 'Participants receiving aflibercept 2q8 switched to HD in the extension phase'}, {'id': 'OG001', 'title': 'HDq12 Aflibercept (Extension)', 'description': 'Participants continued to receive HDq12 aflibercept during the extension phase'}, {'id': 'OG002', 'title': 'HDq16 Aflibercept (Extension)', 'description': 'Participants continued to receive HDq16 aflibercept during the extension phase'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Week 156', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Extension Safety Analysis Set (eSAF): All participants in the SAF who enrolled in the extension phase and completed the extension baseline visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aflibercept 2 mg Every 8 Weeks (2q8)', 'description': 'Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses'}, {'id': 'FG001', 'title': 'High-dose (HD) Aflibercept Every 12 Weeks (HDq12)', 'description': 'Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses'}, {'id': 'FG002', 'title': 'HD Aflibercept Every 16 Weeks (HDq16)', 'description': 'Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses'}, {'id': 'FG003', 'title': '2q8/HD Aflibercept (Extension)', 'description': 'Participants receiving aflibercept 2q8 switched to HD in the extension phase'}, {'id': 'FG004', 'title': 'HDq12 Aflibercept (Extension)', 'description': 'Participants continued to receive HDq12 aflibercept during the extension phase'}, {'id': 'FG005', 'title': 'HDq16 Aflibercept (Extension)', 'description': 'Participants continued to receive HDq16 aflibercept during the extension phase'}], 'periods': [{'title': 'Main Study (Up to Wk 96)', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '167'}, {'groupId': 'FG001', 'numSubjects': '329'}, {'groupId': 'FG002', 'numSubjects': '164'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Treated', 'comment': 'All randomized participants who received at least 1 dose of study drug (Full Analysis Set)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '167'}, {'groupId': 'FG001', 'numSubjects': '328'}, {'groupId': 'FG002', 'numSubjects': '163'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Completed Week 48', 'achievements': [{'groupId': 'FG000', 'numSubjects': '157'}, {'groupId': 'FG001', 'numSubjects': '300'}, {'groupId': 'FG002', 'numSubjects': '156'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Completed Week 60', 'achievements': [{'groupId': 'FG000', 'numSubjects': '155'}, {'groupId': 'FG001', 'numSubjects': '289'}, {'groupId': 'FG002', 'numSubjects': '152'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Completed Week 96', 'achievements': [{'groupId': 'FG000', 'numSubjects': '139'}, {'groupId': 'FG001', 'numSubjects': '256'}, {'groupId': 'FG002', 'numSubjects': '139'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '73'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Non-compliance with protocol by the subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Decision by the investigator/sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Extension Phase (Wk 96 to Wk 156)', 'milestones': [{'type': 'STARTED', 'comment': 'Number of participants treated during extension phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '70'}, {'groupId': 'FG004', 'numSubjects': '130'}, {'groupId': 'FG005', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'comment': 'Number of participants who completed Week 156 (End of Study)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '58'}, {'groupId': 'FG004', 'numSubjects': '103'}, {'groupId': 'FG005', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '27'}, {'groupId': 'FG005', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Decision by the Investigator/Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': "A total of 970 participants were screened and 660 participants were randomized, of whom 658 participants received at least 1 dose of study treatment in the study eye. Fellow eye treatment was allowed with 2 mg aflibercept at the investigator's discretion for indications approved by governing authorities. The treated fellow eye was not considered an additional study eye. Only one study eye per participant was analyzed within the study."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'BG000'}, {'value': '328', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}, {'value': '658', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Aflibercept 2 mg Every 8 Weeks (2q8)', 'description': 'Participants received 2 milligrams (mg) aflibercept every 8 weeks (2q8), following 5 initial monthly doses'}, {'id': 'BG001', 'title': 'High-dose (HD) Aflibercept Every 12 Weeks (HDq12)', 'description': 'Participants received HD aflibercept (8 mg) every 12 weeks (HDq12) following 3 initial monthly doses'}, {'id': 'BG002', 'title': 'HD Aflibercept Every 16 Weeks (HDq16)', 'description': 'Participants received HD aflibercept (8mg) every 16 weeks (HDq16) following 3 initial monthly doses'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'spread': '9.78', 'groupId': 'BG000'}, {'value': '62.1', 'spread': '11.13', 'groupId': 'BG001'}, {'value': '61.9', 'spread': '9.50', 'groupId': 'BG002'}, {'value': '62.3', 'spread': '10.41', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '257', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '401', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '266', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}, {'value': '525', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '231', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}, {'value': '471', 'groupId': 'BG003'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Race', 'unitOfMeasure': 'Participants'}, {'title': 'Best Corrected Visual Acuity (BCVA) in the Study Eye', 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'spread': '11.22', 'groupId': 'BG000'}, {'value': '63.6', 'spread': '10.10', 'groupId': 'BG001'}, {'value': '61.4', 'spread': '11.76', 'groupId': 'BG002'}, {'value': '62.5', 'spread': '10.86', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Early Treatment Diabetic Retinopathy Study (ETDRS) letter score; Only one study eye per participant was analyzed within the study', 'unitOfMeasure': 'Letters', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug; it was based on the treatment assigned to the participant at baseline (as randomized). Only one study eye per participant was analyzed within the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-27', 'size': 1171191, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-25T14:20', 'hasProtocol': True}, {'date': '2022-08-19', 'size': 1311702, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-25T14:20', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 660}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'dispFirstSubmitDate': '2023-05-19', 'completionDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2020-05-26', 'resultsFirstSubmitDate': '2023-07-25', 'studyFirstSubmitQcDate': '2020-06-10', 'dispFirstPostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-27', 'studyFirstPostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letter Score) in the Study Eye at Week 48', 'timeFrame': 'Baseline, Week 48', 'description': 'Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With a ≥2 Step Improvement From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Score at Week 48', 'timeFrame': 'Baseline, Week 48', 'description': 'The DRSS was assessed according to the following scale: 10 = Diabetic retinopathy (DR) absent, 14 = DR questionable, 15 = DR questionable, 20 = Micro-aneurysms only, 35 = Mild Non-proliferative diabetic retinopathy (NPDR), 43 = Moderate NPDR, 47 = Moderately severe NPDR, 53 = Severe NPDR, 61 = Mild Proliferative diabetic retinopathy (PDR), 65 = Moderate PDR, 71 = High-risk PDR, 75 = High-risk PDR, 81 = Advanced PDR: fundus partially obscured, center of macula attached, 85 = Advanced PDR: posterior fundus obscured, or center of macula detached, 90 = cannot grade, even sufficiently for level 81 or 85.'}, {'measure': 'Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline at Week 48', 'timeFrame': 'Baseline, Week 48', 'description': 'Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best). Only one study eye per participant was analyzed within the study'}, {'measure': 'Percentage of Participants With BCVA ≥69 Letters at Week 48', 'timeFrame': 'At Week 48', 'description': 'Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).'}, {'measure': 'Percentage of Participants Without Fluid at Foveal Center at Week 48', 'timeFrame': 'At Week 48', 'description': 'Retinal fluid status was evaluated using spectral domain optical coherence tomography (SD-OCT) on the study eye.'}, {'measure': 'Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 48', 'timeFrame': 'Baseline, Week 48', 'description': 'Central Retinal Thickness (CRT) was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).'}, {'measure': 'Percentage of Participants Without Leakage on Fluorescein Angiography (FA) at Week 48', 'timeFrame': 'At Week 48', 'description': 'Leakage is the release of fluorescein dye from diseased retinal vessels.'}, {'measure': 'Change From Baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) Total Score at Week 48', 'timeFrame': 'Baseline, Week 48', 'description': 'Vision-specific quality of life is assessed with the NEI VFQ-25 (National Eye Institute Visual Function Questionnaire), i.e. a 25-item questionnaire that gives a score on a scale from 0 (worst) to 100 (best = no vision problems).'}, {'measure': 'Systemic Pharmacokinetics (PK) of Aflibercept as Assessed by Plasma Concentrations Through Week 48', 'timeFrame': 'Through Week 48', 'description': 'Concentrations of Free Aflibercept in Plasma by Time and Treatment Group'}, {'measure': 'Change From Baseline in BCVA in the Study Eye in Participants With Both Baseline and Week 48 BCVA', 'timeFrame': 'Baseline, Week 48', 'description': 'Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best). (Per Statistical Analysis Plan (SAP) Version 2.0 Appendix 10.9 for US Only)'}, {'measure': 'Change From 8-weeks Post Initial Treatment Phase in BCVA in the Study Eye in Participants With Both 8-weeks Post Initial Treatment Phase BCVA and Week 48 BCVA', 'timeFrame': 'Baseline, Week 48', 'description': 'Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best). (Per SAP Version 2.0 Appendix 10.9 for US Only)'}, {'measure': 'Change From Baseline in BCVA (Region-specific Analysis) in the Study Eye at Week 60', 'timeFrame': 'Baseline, Week 60', 'description': 'Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).'}, {'measure': 'Assessment of Immunogenicity to Aflibercept by Measuring the Incidence of Treatment-emergent Anti-drug Antibodies (ADA) Response Through Week 96', 'timeFrame': 'Through Week 96', 'description': 'Number of participants with pre-existing immunoreactivity and treatment-emergent ADA response reported'}, {'measure': 'Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Through Week 96', 'timeFrame': 'Through Week 96', 'description': 'A TEAE is an AE starting after the first dose of study drug to the last dose of study drug (active or sham) plus 30 days. Additionally, for patients who are still participating in the study (ie, have not been withdrawn and are continuing in the extension phase of the study) as of the week 96 visit all AEs up through the date of the week 96 visit were considered treatment-emergent.'}, {'measure': 'Number of Participants With Any Serious TEAE Through Week 96', 'timeFrame': 'Through Week 96', 'description': 'A TEAE is an AE starting after the first dose of study drug to the last dose of study drug (active or sham) plus 30 days. Additionally, for patients who are still participating in the study (ie, have not been withdrawn and are continuing in the extension phase of the study) as of the week 96 visit all AEs up through the date of the week 96 visit were considered treatment-emergent.'}, {'measure': 'Number of Participants With Any TEAE Through Week 156', 'timeFrame': 'Through Week 156', 'description': 'TEAEs are defined as AEs starting after the first dose of study drug to the last dose of study drug (active or sham) plus 30 days or week 156 visit, whichever was later.'}, {'measure': 'Number of Participants With Any Serious TEAE Through Week 156', 'timeFrame': 'Through Week 156'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Macular Edema', 'Type 1 Diabetes Mellitus', 'Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '41223900', 'type': 'DERIVED', 'citation': 'Do DV, Wykoff CC, Sivaprasad S, Brown DM, Boyer DS, Sakamoto T, Win P, Joshi S, Salehi-Had H, Seres A, Berliner AJ, Leal S, Vitti R, Chu KW, Reed K, Cheng Y, Bhore R, Bai Z, Schmidt-Ott U, Schmelter T, Schulze A, Hasanbasic Z, Morgan-Warren PJ, Zhang X, Hirshberg B, Yancopoulos GD; PHOTON investigators. Intravitreal Aflibercept 8 mg for Diabetic Macular Edema: 96-Week Results from the Randomized Phase 2/3 PHOTON Trial. Ophthalmology. 2025 Nov 10:S0161-6420(25)00707-9. doi: 10.1016/j.ophtha.2025.10.028. Online ahead of print.'}, {'pmid': '38461843', 'type': 'DERIVED', 'citation': 'Brown DM, Boyer DS, Do DV, Wykoff CC, Sakamoto T, Win P, Joshi S, Salehi-Had H, Seres A, Berliner AJ, Leal S, Vitti R, Chu KW, Reed K, Rao R, Cheng Y, Sun W, Voronca D, Bhore R, Schmidt-Ott U, Schmelter T, Schulze A, Zhang X, Hirshberg B, Yancopoulos GD, Sivaprasad S; PHOTON Investigators. Intravitreal aflibercept 8 mg in diabetic macular oedema (PHOTON): 48-week results from a randomised, double-masked, non-inferiority, phase 2/3 trial. Lancet. 2024 Mar 23;403(10432):1153-1163. doi: 10.1016/S0140-6736(23)02577-1. Epub 2024 Mar 7.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks.\n\nThe secondary objectives of the study are as follows:\n\n* To determine the effect of HD vs. aflibercept on anatomic and other visual measures of response\n* To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Diabetic macular edema (DME) with central involvement in the study eye\n* Best corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye with decreased vision determined to be primarily the result of DME\n* Willing and able to comply with clinic visits and study-related procedures\n* Provide informed consent signed by study participant or legally acceptable representative\n\nExtension Phase: All randomized patients that complete visit 26, week 96, as long as the patient 1) provides informed consent and 2) no treatment for DME has been given in the study eye other than the randomized study treatment.\n\nKey Exclusion Criteria:\n\n* Evidence of macular edema due to any cause other than diabetes mellitus in either eye\n* Active proliferative diabetic retinopathy in the study eye\n* IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) or panretinal laser photocoagulation (PRP) /macular laser photocoagulation within 12 weeks (84 days) or intraocular or periocular corticosteroids within 16 weeks (112 days) of the screening visit in the study eye\n* Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific monoclonal antibodies, gene therapy, etc.) at any time\n* Treatment with ocriplasmin (JETREA®) in the study eye at any time\n\nNOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply'}, 'identificationModule': {'nctId': 'NCT04429503', 'acronym': 'PHOTON', 'briefTitle': 'Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-Masked, Active-Controlled Phase 2/3 Study of the Efficacy and Safety of High-Dose Aflibercept in Patients With Diabetic Macular Edema', 'orgStudyIdInfo': {'id': 'VGFTe-HD-DME-1934'}, 'secondaryIdInfos': [{'id': '2019-003643-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'aflibercept Q8', 'description': 'Administered every 8 weeks after a loading phase', 'interventionNames': ['Drug: aflibercept']}, {'type': 'EXPERIMENTAL', 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