Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT04423718
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2020-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Colombia', 'Denmark', 'Germany', 'Hong Kong', 'Netherlands', 'Turkey (Türkiye)', 'United Kingdom'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C533178', 'term': 'aflibercept'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayer.com', 'phone': '(+) 1-888-8422937', 'title': 'Therapeutic Area Head', 'organization': 'Bayer'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through Week 96, from first dosing up to 30 days after last dosing (active or sham procedure). Through Week 156, from first dosing up to 30 days after last dosing (active or sham procedure) or the Week 156 visit, whichever was later. AE reporting for all-cause mortality considers all deaths occurred at any time during the study before the last contact.', 'description': 'Ocular TEAEs in study eye and non-ocular TEAEs (ocular TEAEs in fellow eye are excluded)', 'eventGroups': [{'id': 'EG000', 'title': 'Aflibercept 2q8 (Week 0- 96)', 'description': 'Participants enrolled in main study received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals.', 'otherNumAtRisk': 336, 'deathsNumAtRisk': 336, 'otherNumAffected': 179, 'seriousNumAtRisk': 336, 'deathsNumAffected': 12, 'seriousNumAffected': 69}, {'id': 'EG001', 'title': 'Aflibercept HDq12 (Week 0- 96)', 'description': 'Participants enrolled in main study received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals. Participants in this group could have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria.', 'otherNumAtRisk': 335, 'deathsNumAtRisk': 335, 'otherNumAffected': 163, 'seriousNumAtRisk': 335, 'deathsNumAffected': 11, 'seriousNumAffected': 83}, {'id': 'EG002', 'title': 'Aflibercept HDq16 (Week 0- 96)', 'description': 'Participants enrolled in main study received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals. Participants in this group could have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria.', 'otherNumAtRisk': 338, 'deathsNumAtRisk': 338, 'otherNumAffected': 180, 'seriousNumAtRisk': 338, 'deathsNumAffected': 7, 'seriousNumAffected': 72}, {'id': 'EG003', 'title': 'All Aflibercept HD (Week 0- 96)', 'description': 'All participants from aflibercept HDq12 (Week 0-96) and aflibercept HDq16 (Week 0-96).', 'otherNumAtRisk': 673, 'deathsNumAtRisk': 673, 'otherNumAffected': 343, 'seriousNumAtRisk': 673, 'deathsNumAffected': 18, 'seriousNumAffected': 155}, {'id': 'EG004', 'title': 'Aflibercept 2q8/HD (Week 0- 156)', 'description': 'Participants enrolled in the extension originally assigned to 2q8 in main study and switched to high dose aflibercept every 12 weeks starting at Week 96. Participants in this group could have their treatment intervals adjusted in the extension according to pre-specified dose regimen modification (E-DRM) criteria.', 'otherNumAtRisk': 208, 'deathsNumAtRisk': 208, 'otherNumAffected': 136, 'seriousNumAtRisk': 208, 'deathsNumAffected': 4, 'seriousNumAffected': 49}, {'id': 'EG005', 'title': 'Aflibercept HDq12 (Week 0- 156)', 'description': 'Participants enrolled in the extension originally assigned to HDq12 in main study and continued with HD aflibercept at their latest dosing interval at Week 96. Participants in this group could have their treatment intervals adjusted in the extension according to pre-specified dose regimen modification (E-DRM) criteria.', 'otherNumAtRisk': 210, 'deathsNumAtRisk': 210, 'otherNumAffected': 120, 'seriousNumAtRisk': 210, 'deathsNumAffected': 7, 'seriousNumAffected': 61}, {'id': 'EG006', 'title': 'Aflibercept HDq16 (Week 0- 156)', 'description': 'Participants enrolled in the extension originally assigned to HDq16 in main study and continued with HD aflibercept at their latest dosing interval at Week 96. Participants in this group could have their treatment intervals adjusted in the extension according to pre-specified dose regimen modification (E-DRM) criteria.', 'otherNumAtRisk': 207, 'deathsNumAtRisk': 207, 'otherNumAffected': 135, 'seriousNumAtRisk': 207, 'deathsNumAffected': 2, 'seriousNumAffected': 61}, {'id': 'EG007', 'title': 'All Aflibercept HD (Week 0- 156)', 'description': 'All participants from aflibercept HDq12 (Week 0-156) and aflibercept HDq16 (Week 0-156). Participants in this group could have their treatment intervals adjusted in the extension according to pre-specified dose regimen modification (E-DRM) criteria.', 'otherNumAtRisk': 417, 'deathsNumAtRisk': 417, 'otherNumAffected': 255, 'seriousNumAtRisk': 417, 'deathsNumAffected': 9, 'seriousNumAffected': 122}], 'otherEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 33, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 62, 'numAffected': 61}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 29, 'numAffected': 27}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 37, 'numAffected': 34}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 35, 'numAffected': 33}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 72, 'numAffected': 67}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 36, 'numAffected': 33}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 26, 'numAffected': 22}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 31, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 24, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 34, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 58, 'numAffected': 44}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 23, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 33, 'numAffected': 29}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 25, 'numAffected': 22}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 64, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 59, 'numAffected': 58}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 73, 'numAffected': 70}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 132, 'numAffected': 128}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 59, 'numAffected': 50}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 45, 'numAffected': 44}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 62, 'numAffected': 59}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 107, 'numAffected': 103}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 40, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 25, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 31, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 56, 'numAffected': 45}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 46, 'numAffected': 28}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 33, 'numAffected': 20}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 38, 'numAffected': 28}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 71, 'numAffected': 48}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 31, 'numAffected': 26}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 20, 'numAffected': 14}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 31, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 19, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 20, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 20, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 40, 'numAffected': 23}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 20, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 21, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 33, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 31, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 27, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 42, 'numAffected': 31}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 24, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 24, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 39, 'numAffected': 25}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 22, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 26, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 49, 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(26.0/27.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Hypochromic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 1, 'numAffected': 1}, {'groupId': 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{'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, 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'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Pulmonary thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Disability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Artificial urinary sphincter implant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Cataract operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Inguinal hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Polypectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Giant cell arteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 336, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 335, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 338, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 673, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 208, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 417, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0/27.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}, {'value': '338', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2q8', 'description': 'Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.'}, {'id': 'OG001', 'title': 'Aflibercept HDq12', 'description': 'Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria'}, {'id': 'OG002', 'title': 'Aflibercept HDq16', 'description': 'Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '7.03', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '6.06', 'spread': '0.77', 'groupId': 'OG001'}, {'value': '5.89', 'spread': '0.72', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.97', 'ciLowerLimit': '-2.87', 'ciUpperLimit': '0.92', 'pValueComment': 'Strictly hierarchical testing procedure: Since p-value below significance level 0.025, fixed sequence testing continued with next primary endpoint (HDq16-2q8) / within EMA/PMDA specific hierarchy with secondary endpoint (BCVA at W60, HDq12-2q8)', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM', 'groupDescription': 'HDq12 - 2q8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Adjusted for baseline BCVA and randomization strata', 'nonInferiorityComment': 'One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin'}, {'pValue': '0.0011', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.14', 'ciLowerLimit': '-2.97', 'ciUpperLimit': '0.69', 'pValueComment': 'Strictly hierarchical testing procedure: Since p-value below significance level 0.025, fixed sequence testing continued with secondary endpoint (no IRF no SRF at W16)/within EMA/PMDA specific hierarchy with secondary endpoint (BCVA at W60, HDq16-2q8)', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM', 'groupDescription': 'HDq16 - 2q8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Adjusted for baseline BCVA and randomization strata', 'nonInferiorityComment': 'One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At baseline and Week 48', 'description': 'Visual function of the study eye was assessed at a distance of 4 meters using the ETDRS BCVA letter score. BCVA scale range is 0 (worst) to 100 (best).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment. Estimand mainly based on hypothetical strategy.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}, {'value': '338', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2q8', 'description': 'Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.'}, {'id': 'OG001', 'title': 'Aflibercept HDq12', 'description': 'Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria'}, {'id': 'OG002', 'title': 'Aflibercept HDq16', 'description': 'Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '7.23', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '6.37', 'spread': '0.74', 'groupId': 'OG001'}, {'value': '6.31', 'spread': '0.66', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.86', 'ciLowerLimit': '-2.57', 'ciUpperLimit': '0.84', 'pValueComment': 'EMA/PMDA specific hierarchy: i.e. secondary endpoint was tested for EMA/PMDA after primary endpoint (HDq12-2q8). Since p-value below significance level 0.025, EMA/PMDA specific fixed sequence testing continued with next primary endpoint (HDq16-2q8)', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM', 'groupDescription': 'HDq12 - 2q8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Adjusted for baseline BCVA and randomization strata', 'nonInferiorityComment': 'One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.92', 'ciLowerLimit': '-2.51', 'ciUpperLimit': '0.66', 'pValueComment': 'EMA/PMDA specific hierarchy: i.e. secondary endpoint was tested after primary endpoint (HDq16-2q8). Since p-value below significance level 0.025, EMA/PMDA specific fixed sequence testing continued with secondary endpoint test (no IRF no SRF at W16)', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM', 'groupDescription': 'HDq16 - 2q8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Adjusted for baseline BCVA and randomization strata', 'nonInferiorityComment': 'One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At baseline and Week 60', 'description': 'Visual function of the study eye was assessed at a distance of 4 meters using the ETDRS BCVA letter score. BCVA scale range is 0 (worst) to 100 (best).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment. Estimand mainly based on hypothetical strategy.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in Central Subfield at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '333', 'groupId': 'OG001'}, {'value': '334', 'groupId': 'OG002'}, {'value': '667', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2q8', 'description': 'Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.'}, {'id': 'OG001', 'title': 'Aflibercept HDq12', 'description': 'Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria'}, {'id': 'OG002', 'title': 'Aflibercept HDq16', 'description': 'Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria'}, {'id': 'OG003', 'title': 'All Aflibercept HD', 'description': 'Included all participants from aflibercept HDq12 and aflibercept HDq16'}], 'classes': [{'categories': [{'measurements': [{'value': '51.6', 'groupId': 'OG000'}, {'value': '61.6', 'groupId': 'OG001'}, {'value': '65.0', 'groupId': 'OG002'}, {'value': '63.3', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.733', 'ciLowerLimit': '5.263', 'ciUpperLimit': '18.204', 'pValueComment': 'Strictly hierarchical testing procedure to adjust for multiplicity.', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach', 'groupDescription': 'All HD - 2q8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'CMH test stratified by baseline BCVA and randomization strata', 'nonInferiorityComment': 'One sided test (alpha = 0.025) for superiority'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 16', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment. Estimand mainly based on hypothetical strategy.\n\nThe Overall Number of Participants Analyzed is not consistent with numbers provided in the Overall Number of Baseline Participants due to missing assessment at the respective visit. These participants with missing assessments were not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Gaining at Least 15 Letters in BCVA From Baseline at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '334', 'groupId': 'OG001'}, {'value': '337', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2q8', 'description': 'Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.'}, {'id': 'OG001', 'title': 'Aflibercept HDq12', 'description': 'Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria'}, {'id': 'OG002', 'title': 'Aflibercept HDq16', 'description': 'Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '22.1', 'groupId': 'OG000'}, {'value': '20.7', 'groupId': 'OG001'}, {'value': '21.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5704', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.748', 'ciLowerLimit': '-7.784', 'ciUpperLimit': '4.287', 'pValueComment': 'Nominal p-value, not adjusted for multiplicity', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach', 'groupDescription': 'HDq12 - 2q8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'CMH test stratified by baseline BCVA and randomization strata', 'nonInferiorityComment': 'Two sided test (alpha = 0.05)'}, {'pValue': '0.7611', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.939', 'ciLowerLimit': '-6.997', 'ciUpperLimit': '5.119', 'pValueComment': 'Nominal p-value, not adjusted for multiplicity', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach', 'groupDescription': 'HDq16 - 2q8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'CMH test stratified by baseline BCVA and randomization strata', 'nonInferiorityComment': 'Two sided test (alpha = 0.05)'}], 'paramType': 'NUMBER', 'timeFrame': 'At baseline and Week 48', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment.\n\nThe Overall Number of Participants Analyzed is not consistent with numbers provided in the Overall Number of Baseline Participants due to 1 participant per each treatment group with no post-baseline BCVA. These participants with missing assessments were not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving an ETDRS Letter Score of at Least 69 (Approximate 20/40 Snellen Equivalent) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '334', 'groupId': 'OG001'}, {'value': '337', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2q8', 'description': 'Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.'}, {'id': 'OG001', 'title': 'Aflibercept HDq12', 'description': 'Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria'}, {'id': 'OG002', 'title': 'Aflibercept HDq16', 'description': 'Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '57.9', 'groupId': 'OG000'}, {'value': '56.9', 'groupId': 'OG001'}, {'value': '54.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9554', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.182', 'ciLowerLimit': '-6.565', 'ciUpperLimit': '6.200', 'pValueComment': 'Nominal p-value, not adjusted for multiplicity', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach', 'groupDescription': 'HDq12 - 2q8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'CMH test stratified by baseline BCVA and randomization strata', 'nonInferiorityComment': 'Two sided test (alpha = 0.05)'}, {'pValue': '0.4834', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.221', 'ciLowerLimit': '-8.435', 'ciUpperLimit': '3.994', 'pValueComment': 'Nominal p-value, not adjusted for multiplicity', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach', 'groupDescription': 'HDq16 - 2q8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'CMH test stratified by baseline BCVA and randomization strata', 'nonInferiorityComment': 'Two sided test (alpha = 0.05)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 48', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment.\n\nThe Overall Number of Participants Analyzed is not consistent with numbers provided in the Overall Number of Baseline Participants due to 1 participant per each treatment group with no post-baseline BCVA. These participants with missing assessments were not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Choroidal Neovascularization (CNV) Size From Baseline to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}, {'value': '338', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2q8', 'description': 'Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.'}, {'id': 'OG001', 'title': 'Aflibercept HDq12', 'description': 'Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria'}, {'id': 'OG002', 'title': 'Aflibercept HDq16', 'description': 'Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.43', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '-3.65', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '-2.91', 'spread': '0.29', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.22', 'ciLowerLimit': '-1.94', 'ciUpperLimit': '-0.51', 'pValueComment': 'Nominal p-value, not adjusted for multiplicity', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM', 'groupDescription': 'HDq12 - 2q8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Adjusted for baseline CNV size and randomization strata', 'nonInferiorityComment': 'Two sided test (alpha = 0.05)'}, {'pValue': '0.2076', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-1.22', 'ciUpperLimit': '0.27', 'pValueComment': 'Nominal p-value, not adjusted for multiplicity', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM', 'groupDescription': 'HDq16 - 2q8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Adjusted for baseline CNV size and randomization strata', 'nonInferiorityComment': 'Two sided test (alpha = 0.05)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At baseline and Week 48', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Change in Total Lesion Area From Baseline to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}, {'value': '338', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2q8', 'description': 'Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.'}, {'id': 'OG001', 'title': 'Aflibercept HDq12', 'description': 'Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria'}, {'id': 'OG002', 'title': 'Aflibercept HDq16', 'description': 'Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '0.09', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-0.46', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '-0.35', 'spread': '0.20', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0287', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '-0.06', 'pValueComment': 'Nominal p-value, not adjusted for multiplicity', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM', 'groupDescription': 'HDq12 - 2q8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Adjusted for baseline total lesion area and randomization strata', 'nonInferiorityComment': 'Two sided test (alpha = 0.05)'}, {'pValue': '0.0870', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '0.06', 'pValueComment': 'Nominal p-value, not adjusted for multiplicity', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM', 'groupDescription': 'HDq16 - 2q8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Adjusted for baseline total lesion area and randomization strata', 'nonInferiorityComment': 'Two sided test (alpha = 0.05)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At baseline and Week 48', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in the Center Subfield at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '332', 'groupId': 'OG001'}, {'value': '334', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2q8', 'description': 'Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.'}, {'id': 'OG001', 'title': 'Aflibercept HDq12', 'description': 'Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria'}, {'id': 'OG002', 'title': 'Aflibercept HDq16', 'description': 'Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '59.4', 'groupId': 'OG000'}, {'value': '71.1', 'groupId': 'OG001'}, {'value': '66.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.725', 'ciLowerLimit': '4.527', 'ciUpperLimit': '18.923', 'pValueComment': 'Nominal p-value, not adjusted for multiplicity', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach', 'groupDescription': 'HDq12 - 2q8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'CMH test stratified by baseline BCVA and randomization strata', 'nonInferiorityComment': 'Two sided test (alpha = 0.05)'}, {'pValue': '0.0458', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.451', 'ciLowerLimit': '0.142', 'ciUpperLimit': '14.760', 'pValueComment': 'Nominal p-value, not adjusted for multiplicity', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was imputed by LOCF approach', 'groupDescription': 'HDq16 - 2q8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'CMH test stratified by baseline BCVA and randomization strata', 'nonInferiorityComment': 'Two sided test (alpha = 0.05)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 48', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment.\n\nThe Overall Number of Participants Analyzed is not consistent with numbers provided in the Overall Number of Baseline Participants due to missing assessments at the respective visit. These participants with missing assessments were not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Central Subfield Retinal Thickness (CST) at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}, {'value': '338', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2q8', 'description': 'Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.'}, {'id': 'OG001', 'title': 'Aflibercept HDq12', 'description': 'Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria'}, {'id': 'OG002', 'title': 'Aflibercept HDq16', 'description': 'Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '-136.25', 'spread': '4.24', 'groupId': 'OG000'}, {'value': '-147.37', 'spread': '4.01', 'groupId': 'OG001'}, {'value': '-146.76', 'spread': '3.76', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0283', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.12', 'ciLowerLimit': '-21.06', 'ciUpperLimit': '-1.18', 'pValueComment': 'Nominal p-value, not adjusted for multiplicity', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM', 'groupDescription': 'HDq12 - 2q8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Adjusted for baseline CST and randomization strata', 'nonInferiorityComment': 'Two sided test (alpha = 0.05)'}, {'pValue': '0.0321', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.51', 'ciLowerLimit': '-20.12', 'ciUpperLimit': '-0.90', 'pValueComment': 'Nominal p-value, not adjusted for multiplicity', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM', 'groupDescription': 'HDq16 - 2q8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Adjusted for baseline CST and randomization strata', 'nonInferiorityComment': 'Two sided test (alpha = 0.05)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At baseline and Week 48', 'unitOfMeasure': 'µm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Total Score at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}, {'value': '338', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2q8', 'description': 'Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.'}, {'id': 'OG001', 'title': 'Aflibercept HDq12', 'description': 'Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria'}, {'id': 'OG002', 'title': 'Aflibercept HDq16', 'description': 'Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria'}], 'classes': [{'categories': [{'measurements': [{'value': '4.22', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '3.50', 'spread': '0.70', 'groupId': 'OG001'}, {'value': '3.35', 'spread': '0.72', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3817', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.72', 'ciLowerLimit': '-2.35', 'ciUpperLimit': '0.90', 'pValueComment': 'Nominal p-value, not adjusted for multiplicity', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM', 'groupDescription': 'HDq12 - 2q8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Adjusted for baseline NEI-VFQ-25 total score and randomization strata', 'nonInferiorityComment': 'Two sided test (alpha = 0.05)'}, {'pValue': '0.3070', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.87', 'ciLowerLimit': '-2.55', 'ciUpperLimit': '0.80', 'pValueComment': 'Nominal p-value, not adjusted for multiplicity', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, missing injection, prohibited medication) were censored. Missing/censored data was handled implicitly by MMRM', 'groupDescription': 'HDq16 - 2q8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'Adjusted for baseline NEI-VFQ-25 total score and randomization strata', 'nonInferiorityComment': 'Two sided test (alpha = 0.05)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At baseline and Week 48', 'description': 'NEI VFQ-25 was a 25-item questionnaire that gave a score on a scale from 0 (worst) to 100 (best = no vision problems)', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Systemic Exposure to Aflibercept as Assessed by Plasma Concentrations of Free, Adjusted Bound and Total Aflibercept From Baseline Through Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}, {'value': '313', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2q8', 'description': 'Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.'}, {'id': 'OG001', 'title': 'Aflibercept HDq12', 'description': 'Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria'}, {'id': 'OG002', 'title': 'Aflibercept HDq16', 'description': 'Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated (less than 2/3 of values per timepoint are \\>= Lower level of quantification (LLOQ) for geometric mean calculation).', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated (less than 2/3 of values per timepoint are \\>= Lower level of quantification (LLOQ) for geometric mean calculation).', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated (less than 2/3 of values per timepoint are \\>= Lower level of quantification (LLOQ) for geometric mean calculation).', 'groupId': 'OG002'}]}]}, {'title': 'Visit 5: within 3 to 7 days after the Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}, {'value': '255', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '70.29', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '78.69', 'groupId': 'OG001'}, {'value': '0.13', 'spread': '82.50', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}, {'value': '302', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated (less than 2/3 of values per timepoint are \\>= Lower level of quantification (LLOQ) for geometric mean calculation).', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '81.35', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '84.06', 'groupId': 'OG002'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}, {'value': '283', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated (less than 2/3 of values per timepoint are \\>= Lower level of quantification (LLOQ) for geometric mean calculation).', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated (less than 2/3 of values per timepoint are \\>= Lower level of quantification (LLOQ) for geometric mean calculation).', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated (less than 2/3 of values per timepoint are \\>= Lower level of quantification (LLOQ) for geometric mean calculation).', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated (less than 2/3 of values per timepoint are \\>= Lower level of quantification (LLOQ) for geometric mean calculation).', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated (less than 2/3 of values per timepoint are \\>= Lower level of quantification (LLOQ) for geometric mean calculation).', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated (less than 2/3 of values per timepoint are \\>= Lower level of quantification (LLOQ) for geometric mean calculation).', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Up to Week 48', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set: included all participants who received any study treatment and who had at least 1 non-missing drug concentration measurement following the first dose of study treatment'}, {'type': 'SECONDARY', 'title': 'Incidence of Treatment-emergent Anti-drug Antibodies (ADA) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}, {'value': '295', 'groupId': 'OG002'}, {'value': '590', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2q8', 'description': 'Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.'}, {'id': 'OG001', 'title': 'Aflibercept HDq12', 'description': 'Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria'}, {'id': 'OG002', 'title': 'Aflibercept HDq16', 'description': 'Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria'}, {'id': 'OG003', 'title': 'All Aflibercept HD', 'description': 'All participants from aflibercept HDq12 (Week 0-96) and aflibercept HDq16 (Week 0-96).'}], 'classes': [{'title': 'Treatment-emergent positive or Treatment-boosted, maximum ADA titers - Low (< 1000)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}]}, {'title': 'Treatment-emergent positive or Treatment-boosted, maximum ADA titers - Moderate (1000-10000)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Treatment-emergent positive or Treatment-boosted, maximum ADA titers - High (> 10000)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to week 96', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aflibercept 2q8 (Week 0-96) / HD (up to Week 156)', 'description': 'Participants enrolled in main study received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals up to 96 weeks. Participants enrolled in the extension originally assigned to 2q8 in main study and switched to high dose aflibercept starting at Week 96.'}, {'id': 'FG001', 'title': 'Aflibercep HDq12 (Week 0-156)', 'description': 'Participants enrolled in main study received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants enrolled in the extension continued with HD aflibercept at their latest dosing interval at Week 96.'}, {'id': 'FG002', 'title': 'Aflibercept HDq16 (Week 0-156)', 'description': 'Participants enrolled in main study received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants enrolled in the extension continued with HD aflibercept at their latest dosing interval at Week 96.'}], 'periods': [{'title': 'Main Study', 'milestones': [{'type': 'STARTED', 'comment': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '336'}, {'groupId': 'FG001', 'numSubjects': '335'}, {'groupId': 'FG002', 'numSubjects': '338'}]}, {'type': 'COMPLETED', 'comment': 'Completed study treatment until Week 96', 'achievements': [{'groupId': 'FG000', 'numSubjects': '286'}, {'groupId': 'FG001', 'numSubjects': '291'}, {'groupId': 'FG002', 'numSubjects': '292'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '46'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COVID-19 pandemic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}, {'title': 'Extension Phase', 'milestones': [{'type': 'STARTED', 'comment': 'Enrolled in extension', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '210'}, {'groupId': 'FG002', 'numSubjects': '207'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '210'}, {'groupId': 'FG002', 'numSubjects': '207'}]}, {'type': 'COMPLETED', 'comment': 'Completed study treatment through Week 156', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}, {'groupId': 'FG001', 'numSubjects': '186'}, {'groupId': 'FG002', 'numSubjects': '191'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Logistical problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'The study was conducted at 251 centers in 27 countries/regions with first participant first visit on 20-AUG-2020 and last participant last visit (Week 156) on 07-Aug-2024.', 'preAssignmentDetails': 'Overall, 1395 participants were screened, of whom 383 participants did not complete screening, 1 participant was randomized in error although he/she did not complete screening and had withdrawn consent. A total of 1011 participants were randomized in nearly equal numbers to 1 of the 3 treatment groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'BG000'}, {'value': '335', 'groupId': 'BG001'}, {'value': '338', 'groupId': 'BG002'}, {'value': '1009', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Aflibercept 2q8', 'description': 'Participants received aflibercept 2 mg administered every 8 weeks after 3 initial injections at 4-week intervals, up to 96 weeks.'}, {'id': 'BG001', 'title': 'Aflibercept HDq12', 'description': 'Participants received high dose (HD) aflibercept administered every 12 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified dose regimen modification (DRM) criteria'}, {'id': 'BG002', 'title': 'Aflibercept HDq16', 'description': 'Participants received high dose (HD) aflibercept administered every 16 weeks after 3 initial injections at 4-week intervals, up to 96 weeks. Participants in this group can have their treatment intervals adjusted according to pre-specified DRM criteria'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'BG000'}, {'value': '335', 'groupId': 'BG001'}, {'value': '338', 'groupId': 'BG002'}, {'value': '1009', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '74.2', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '74.7', 'spread': '7.9', 'groupId': 'BG001'}, {'value': '74.5', 'spread': '8.5', 'groupId': 'BG002'}, {'value': '74.5', 'spread': '8.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'BG000'}, {'value': '335', 'groupId': 'BG001'}, {'value': '338', 'groupId': 'BG002'}, {'value': '1009', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}, {'value': '550', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}, {'value': '459', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'BG000'}, {'value': '335', 'groupId': 'BG001'}, {'value': '338', 'groupId': 'BG002'}, {'value': '1009', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '322', 'groupId': 'BG000'}, {'value': '322', 'groupId': 'BG001'}, {'value': '326', 'groupId': 'BG002'}, {'value': '970', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline BCVA measured by the ETDRS letter score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'BG000'}, {'value': '335', 'groupId': 'BG001'}, {'value': '338', 'groupId': 'BG002'}, {'value': '1009', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '58.9', 'spread': '14.0', 'groupId': 'BG000'}, {'value': '59.9', 'spread': '13.4', 'groupId': 'BG001'}, {'value': '60.0', 'spread': '12.4', 'groupId': 'BG002'}, {'value': '59.6', 'spread': '13.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Visual function of the study eye was assessed at a distance of 4 meters 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': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline choroidal neovascularization (CNV) size', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'BG000'}, {'value': '335', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}, {'value': '1008', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6.3593', 'spread': '5.0394', 'groupId': 'BG000'}, {'value': '5.9768', 'spread': '4.8306', 'groupId': 'BG001'}, {'value': '6.5459', 'spread': '5.5315', 'groupId': 'BG002'}, {'value': '6.2946', 'spread': '5.1433', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm²', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set, except 1 participant who did not have a valid baseline measure.'}, {'title': 'Baseline total lesion area', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'BG000'}, {'value': '335', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}, {'value': '1007', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6.8647', 'spread': '5.4145', 'groupId': 'BG000'}, {'value': '6.3820', 'spread': '5.0664', 'groupId': 'BG001'}, {'value': '6.8814', 'spread': '5.6514', 'groupId': 'BG002'}, {'value': '6.7097', 'spread': '5.3827', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm²', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set, except 2 participants who did not have a valid baseline measure.'}, {'title': 'Baseline central subfield retinal thickness (CST)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'BG000'}, {'value': '335', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}, {'value': '1006', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '367.1', 'spread': '133.6', 'groupId': 'BG000'}, {'value': '370.3', 'spread': '123.7', 'groupId': 'BG001'}, {'value': '370.7', 'spread': '132.7', 'groupId': 'BG002'}, {'value': '369.3', 'spread': '130.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'µm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set, except 3 participants who did not have a valid baseline measure.'}, {'title': 'Baseline NEI-VFQ-25 total score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'BG000'}, {'value': '321', 'groupId': 'BG001'}, {'value': '316', 'groupId': 'BG002'}, {'value': '954', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '77.8082', 'spread': '14.4206', 'groupId': 'BG000'}, {'value': '76.3575', 'spread': '15.1213', 'groupId': 'BG001'}, {'value': '77.6670', 'spread': '15.3980', 'groupId': 'BG002'}, {'value': '77.2733', 'spread': '14.9843', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'NEI-VFQ-25 = National Eye Institute Visual Functioning Questionnaire-25\n\nNEI VFQ-25 was a 25-item questionnaire that gave a score on a scale from 0 (worst) to 100 (best = no vision problems)', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set, with the participants who completed the NEI-VFQ-25 at baseline.'}], 'populationDescription': 'Full analysis set: included all participants who had been randomly assigned to study treatment and who received at least 1 dose of study treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-27', 'size': 4606136, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-09T22:05', 'hasProtocol': True}, {'date': '2022-08-22', 'size': 1035199, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-09T22:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Up to Week 108: Participant and Investigator masked. Week 108 to Week 156: Participant and Investigator unmasked to treatment intervals.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1011}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2020-06-08', 'resultsFirstSubmitDate': '2023-07-09', 'studyFirstSubmitQcDate': '2020-06-08', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2023-08-11', 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 48', 'timeFrame': 'At baseline and Week 48', 'description': 'Visual function of the study eye was assessed at a distance of 4 meters using the ETDRS BCVA letter score. BCVA scale range is 0 (worst) to 100 (best).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 60', 'timeFrame': 'At baseline and Week 60', 'description': 'Visual function of the study eye was assessed at a distance of 4 meters using the ETDRS BCVA letter score. BCVA scale range is 0 (worst) to 100 (best).'}, {'measure': 'Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in Central Subfield at Week 16', 'timeFrame': 'At Week 16'}, {'measure': 'Percentage of Participants Gaining at Least 15 Letters in BCVA From Baseline at Week 48', 'timeFrame': 'At baseline and Week 48'}, {'measure': 'Percentage of Participants Achieving an ETDRS Letter Score of at Least 69 (Approximate 20/40 Snellen Equivalent) at Week 48', 'timeFrame': 'At Week 48'}, {'measure': 'Change in Choroidal Neovascularization (CNV) Size From Baseline to Week 48', 'timeFrame': 'At baseline and Week 48'}, {'measure': 'Change in Total Lesion Area From Baseline to Week 48', 'timeFrame': 'At baseline and Week 48'}, {'measure': 'Percentage of Participants With no Intraretinal Fluid (IRF) and no Subretinal Fluid (SRF) in the Center Subfield at Week 48', 'timeFrame': 'At Week 48'}, {'measure': 'Change From Baseline in Central Subfield Retinal Thickness (CST) at Week 48', 'timeFrame': 'At baseline and Week 48'}, {'measure': 'Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Total Score at Week 48', 'timeFrame': 'At baseline and Week 48', 'description': 'NEI VFQ-25 was a 25-item questionnaire that gave a score on a scale from 0 (worst) to 100 (best = no vision problems)'}, {'measure': 'Systemic Exposure to Aflibercept as Assessed by Plasma Concentrations of Free, Adjusted Bound and Total Aflibercept From Baseline Through Week 48', 'timeFrame': 'Up to Week 48'}, {'measure': 'Incidence of Treatment-emergent Anti-drug Antibodies (ADA) Response', 'timeFrame': 'Up to week 96'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nAMD'], 'conditions': ['Neovascular Age-Related Macular Degeneration']}, 'referencesModule': {'references': [{'pmid': '41411005', 'type': 'DERIVED', 'citation': 'Lee WK, Wong TY, Chen SJ, Sun X, Cheung CMG, Silva R, Ricci F, Zhang X, Machewitz T, Schulze A, Schmidt-Ott UM, Zhao M, Hasanbasic Z, Leal S, Iida T; PULSAR Study Investigators. Aflibercept 8 mg in Polypoidal Choroidal Vasculopathy: Post Hoc Analysis of the PULSAR Randomized Clinical Trial. JAMA Ophthalmol. 2025 Dec 18. doi: 10.1001/jamaophthalmol.2025.5098. Online ahead of print.'}, {'pmid': '40876598', 'type': 'DERIVED', 'citation': 'Korobelnik JF, Lanzetta P, Leal S, Holz FG, Clark WL, Eichenbaum D, Iida T, Sun X, Berliner AJ, Schulze A, Zhao M, Schmelter T, Schmidt-Ott U, Zhang X, Morgan-Warren P, Hasanbasic Z, Vitti R, Chu KW, Reed K, Bhore R, Cheng Y, Bai Z, Hirshberg B, Yancopoulos GD, Wong TY; PULSAR Investigators. Intravitreal Aflibercept 8 mg in Neovascular Age-Related Macular Degeneration: Ninety-Six-Week Results from the Randomized Phase 3 PULSAR Trial. Ophthalmology. 2025 Aug 26:S0161-6420(25)00532-9. doi: 10.1016/j.ophtha.2025.08.022. Online ahead of print.'}, {'pmid': '38461841', 'type': 'DERIVED', 'citation': 'Lanzetta P, Korobelnik JF, Heier JS, Leal S, Holz FG, Clark WL, Eichenbaum D, Iida T, Xiaodong S, Berliner AJ, Schulze A, Schmelter T, Schmidt-Ott U, Zhang X, Vitti R, Chu KW, Reed K, Rao R, Bhore R, Cheng Y, Sun W, Hirshberg B, Yancopoulos GD, Wong TY; PULSAR Investigators. Intravitreal aflibercept 8 mg in neovascular age-related macular degeneration (PULSAR): 48-week results from a randomised, double-masked, non-inferiority, phase 3 trial. Lancet. 2024 Mar 23;403(10432):1141-1152. doi: 10.1016/S0140-6736(24)00063-1. Epub 2024 Mar 7.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/', 'label': 'Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.'}]}, 'descriptionModule': {'briefSummary': 'In this study researchers want to learn more about changes in visual acuity (clarity of vision) with a high dose treatment with Aflibercept (Eylea) in patients suffering from neovascular age-related macular degeneration (nAMD). Neovascular AMD is an eye disease that causes blurred vision or a blind spot due to abnormal blood vessels that leak fluid or blood into the light sensitive lining inside the eye (retina). The fluid buildup causes the central part of the retina (macula) responsible for sharp, straight-ahead vision to swell and thicken (edema), which distorts vision.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active subfoveal CNV secondary to nAMD, including juxtafoveal lesions that affect the fovea as assessed in the study eye.\n* Total area of CNV (including both classic and occult components) must comprise greater than 50% of the total lesion area in the study eye.\n* BCVA ETDRS letter score of 78 to 24 (corresponding to a Snellen equivalent of approximately 20/32 to 20/320) in the study eye.\n* Decrease in BCVA determined to be primarily the result of nAMD in the study eye.\n* Presence of IRF and/or SRF affecting the central subfield of the study eye on OCT.\n* Contraceptive use by men or women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical studies.\n* Other protocol-specified inclusion criteria.\n\nAdditional inclusion criteria for Year 3:\n\n* At least one BCVA value and one central subfield retinal thickness (CST) value from measurements at one of the following visits: Visit 24 (Week 84), Visit 25 (Week 88) or Visit 26 (Week 92).\n* Participant is enrolled at a site that participates in the extension period.\n\nExclusion Criteria:\n\n* Causes of CNV other than nAMD in the study eye.\n* Scar, fibrosis, or atrophy involving the central subfield in the study eye.\n* Presence of retinal pigment epithelial tears or rips involving the central subfield in the study eye.\n* Uncontrolled glaucoma (defined as IOP \\>25 mmHg despite treatment with anti-glaucoma medication) in the study eye.\n* History of idiopathic or autoimmune uveitis in the study eye.\n* Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any refractive or cataract surgery.\n* History or clinical evidence of diabetic retinopathy, diabetic macular edema, or any retinal vascular disease other than nAMD in either eye.\n* Evidence of extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening/randomization.\n* Uncontrolled blood pressure (defined as systolic \\>160 mmHg or diastolic \\>95 mmHg).\n* Any prior or concomitant ocular (in the study eye) or systemic treatment (with an investigational or approved, anti-VEGF or other agent) or surgery for nAMD, except dietary supplements or vitamins.\n* Other protocol-specified exclusion criteria'}, 'identificationModule': {'nctId': 'NCT04423718', 'acronym': 'PULSAR', 'briefTitle': 'Study of the Effects of High Dose Aflibercept Injected Into the Eye of Patients With an Age-related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration', 'orgStudyIdInfo': {'id': '20968'}, 'secondaryIdInfos': [{'id': '2019-003851-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aflibercept 2q8', 'description': 'In the double-masked study part (Years 1 and 2), Aflibercept 2 mg administered every 8 weeks after a loading phase. (Active Comparator) In Year 3, high dose aflibercept administered according to individual patient response. (Experimental)', 'interventionNames': ['Drug: Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)', 'Drug: Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)']}, {'type': 'EXPERIMENTAL', 'label': 'Aflibercept HDq12', 'description': 'Aflibercept high dose (HD) administered every 12 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response.', 'interventionNames': ['Drug: Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)']}, {'type': 'EXPERIMENTAL', 'label': 'Aflibercept HDq16', 'description': 'Aflibercept high dose administered every 16 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response.', 'interventionNames': ['Drug: Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)']}], 'interventions': [{'name': 'Aflibercept High Dose VEGF Trap-Eye (BAY86-5321)', 'type': 'DRUG', 'description': 'Solution in Vial, intravitreal (IVT) injection', 'armGroupLabels': ['Aflibercept 2q8', 'Aflibercept HDq12', 'Aflibercept HDq16']}, {'name': 'Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)', 'type': 'DRUG', 'description': 'Solution in Vial, 2 mg, intravitreal (IVT) injection', 'armGroupLabels': ['Aflibercept 2q8']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85021-8865', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Retina & Vitreous Consultants - Central Phoenix Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Retina Consultants of Orange County - Fullerton', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Northern California Retina Vitreous Associates - 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Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}