Viewing Study NCT05850520

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Ignite Creation Date: 2025-12-25 @ 4:23 AM
Ignite Modification Date: 2025-12-26 @ 3:26 AM
Study NCT ID: NCT05850520
Status: COMPLETED
Last Update Posted: 2025-12-18
First Post: 2023-04-28
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Mexico'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C533178', 'term': 'aflibercept'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}, {'id': 'D005451', 'term': 'Fluorescein Angiography'}], 'ancestors': [{'id': 'D000792', 'term': 'Angiography'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003941', 'term': 'Diagnostic Techniques, Ophthalmological'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayer.com', 'phone': '(+) 1-888-8422937', 'title': 'Therapeutic Area Head', 'organization': 'Bayer'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected from the first injection (active or sham) up to the last injection (active or sham) plus 30 days. AE reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to cut-off date for the primary completion analysis 07 NOV 2024 (approximately 36 weeks).', 'description': 'Ocular treatment-emergent adverse events (TEAEs) in study eye and non-ocular TEAEs (ocular TEAEs in fellow eye are excluded)', 'eventGroups': [{'id': 'EG000', 'title': 'Aflibercept 2q4', 'description': 'Participants received aflibercept 2mg administered every 4 weeks.', 'otherNumAtRisk': 301, 'deathsNumAtRisk': 301, 'otherNumAffected': 188, 'seriousNumAtRisk': 301, 'deathsNumAffected': 2, 'seriousNumAffected': 32}, {'id': 'EG001', 'title': 'Aflibercept 8q8/3', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 3 initial injections at 4-week intervals.', 'otherNumAtRisk': 293, 'deathsNumAtRisk': 293, 'otherNumAffected': 184, 'seriousNumAtRisk': 293, 'deathsNumAffected': 2, 'seriousNumAffected': 23}, {'id': 'EG002', 'title': 'Aflibercept 8q8/5', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 5 initial injections at 4-week intervals.', 'otherNumAtRisk': 298, 'deathsNumAtRisk': 298, 'otherNumAffected': 176, 'seriousNumAtRisk': 298, 'deathsNumAffected': 3, 'seriousNumAffected': 26}, {'id': 'EG003', 'title': 'All Aflibercept 8 mg', 'description': 'Pooled aflibercept 8 mg administered every 8 weeks, after 3 or 5 initial injections at 4-week intervals.', 'otherNumAtRisk': 591, 'deathsNumAtRisk': 591, 'otherNumAffected': 360, 'seriousNumAtRisk': 591, 'deathsNumAffected': 5, 'seriousNumAffected': 49}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Lymphocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Monocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Neutrophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Blood loss anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Hypertensive heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Tricuspid valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Left ventricular hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Left ventricular enlargement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Ventricular dyssynchrony', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Thalassaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Factor V Leiden mutation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Presbyacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Ear inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Autoimmune thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Thyroid mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Aphakia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Blepharospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Diabetic nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 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'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Uterine haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Pelvic organ prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Medical induction of coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Giant cell arteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 301, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 293, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 591, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (27.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '298', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2q4', 'description': 'Participants received aflibercept 2 mg administered every 4 weeks.'}, {'id': 'OG001', 'title': 'Aflibercept 8q8/3', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 3 initial injections at 4-week intervals.'}, {'id': 'OG002', 'title': 'Aflibercept 8q8/5', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 5 initial injections at 4-week intervals.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '17.4', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '18.3', 'spread': '0.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '1.9', 'pValueComment': '1-sided p-value.', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, prohibited medication, missing injection) were censored. Missing/censored data was handled implicitly by MMRM.', 'groupDescription': '8q8/3 -2q4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Baseline BCVA measurement was used as a covariate and treatment group, visit, and the stratification variables as fixed factors.', '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': '0.8', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '2.7', 'pValueComment': '1-sided p-value.', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond intercurrent events (premature discontinuation of treatment, prohibited medication, missing injection) were censored. Missing/censored data was handled implicitly by MMRM.', 'groupDescription': '8q8/5 -2q4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Baseline BCVA measurement was used as a covariate and treatment group, visit, and the stratification variables as fixed factors.', 'nonInferiorityComment': 'One-sided test (alpha=0.025) for non-inferiority at a 4-letter margin.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At Week 36', 'description': 'BCVA: Best-Corrected Visual Acuity; ETDRS: Early Treatment Diabetic Retinopathy Study; ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity)', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): All participants randomly assigned to study intervention who were exposed to study intervention (active or sham injection) at least once.'}, {'type': 'SECONDARY', 'title': 'Number of Active Injections From Baseline to Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '298', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2q4', 'description': 'Participants received aflibercept 2 mg administered every 4 weeks.'}, {'id': 'OG001', 'title': 'Aflibercept 8q8/3', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 3 initial injections at 4-week intervals.'}, {'id': 'OG002', 'title': 'Aflibercept 8q8/5', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 5 initial injections at 4-week intervals.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '6.9', 'spread': '0.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.7', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '-2.6', 'pValueComment': 'Nominal p-value based on a non-parametric rank ANCOVA adjusted for baseline BCVA, baseline CST, and the stratification variables.', 'estimateComment': 'Estimation based on composite strategy for premature treatment discontinuation due to treatment related AEs and hypothetical strategy for premature treatment discontinuation due to other reasons. Hypothetical values imputed using a MI model.', 'groupDescription': '8q8/3 -2q4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline BCVA, baseline CST, and the stratification variables.', 'nonInferiorityComment': 'Two-sided test (alpha = 0.05)'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '-1.7', 'pValueComment': 'Nominal p-value based on a non-parametric rank ANCOVA adjusted for baseline BCVA, baseline CST, and the stratification variables.', 'estimateComment': 'Estimation based on composite strategy for premature treatment discontinuation due to treatment related AEs and hypothetical strategy for premature treatment discontinuation due to other reasons. Hypothetical values imputed using a MI model.', 'groupDescription': '8q8/5 -2q4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline BCVA, baseline CST, and the stratification variables.', 'nonInferiorityComment': 'Two-sided test (alpha = 0.05)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Week 36', 'description': 'Active injections refer to the number of injections that were actually administered, as opposed to the number of planned injections.', 'unitOfMeasure': 'Number of active injections', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): All participants randomly assigned to study intervention who were exposed to study intervention (active or sham injection) at least once.'}, {'type': 'SECONDARY', 'title': 'Participants Gaining at Least 15 Letters in BCVA From Baseline at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2q4', 'description': 'Participants received aflibercept 2 mg administered every 4 weeks.'}, {'id': 'OG001', 'title': 'Aflibercept 8q8/3', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 3 initial injections at 4-week intervals.'}, {'id': 'OG002', 'title': 'Aflibercept 8q8/5', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 5 initial injections at 4-week intervals.'}], 'classes': [{'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '161', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline at Week 36', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): All participants randomly assigned and exposed to study intervention (active or sham injection) at least once.\n\nThe Overall Number of Participants Analyzed differs from the Overall Number of Baseline Participants because only observed cases were used, excluding data after an intercurrent event (ICE) (e.g., stopping intervention or using prohibited medication before Week 36). Missing cases were not included.'}, {'type': 'SECONDARY', 'title': 'Participants Achieving an ETDRS Letter Score of at Least 69 (Approximate 20/40 Snellen Equivalent) at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '248', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2q4', 'description': 'Participants received aflibercept 2 mg administered every 4 weeks.'}, {'id': 'OG001', 'title': 'Aflibercept 8q8/3', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 3 initial injections at 4-week intervals.'}, {'id': 'OG002', 'title': 'Aflibercept 8q8/5', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 5 initial injections at 4-week intervals.'}], 'classes': [{'categories': [{'measurements': [{'value': '179', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '189', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 36', 'description': 'ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): All participants randomly assigned and exposed to study intervention (active or sham injection) at least once.\n\nThe Overall Number of Participants Analyzed differs from the Overall Number of Baseline Participants because only observed cases were used, excluding data after an intercurrent event (ICE) (e.g., stopping intervention or using prohibited medication before Week 36). Missing cases were not included.'}, {'type': 'SECONDARY', 'title': 'Participants Having no Intraretinal Fluid (IRF) and no Sub-retinal Fluid (SRF) in the Center Subfield at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '247', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2q4', 'description': 'Participants received aflibercept 2 mg administered every 4 weeks.'}, {'id': 'OG001', 'title': 'Aflibercept 8q8/3', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 3 initial injections at 4-week intervals.'}, {'id': 'OG002', 'title': 'Aflibercept 8q8/5', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 5 initial injections at 4-week intervals.'}], 'classes': [{'categories': [{'measurements': [{'value': '221', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Week 36', 'description': 'Number of participants with no retinal fluid (no IRF and no SRF) in the central subfield at Week 36', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): All participants randomly assigned and exposed to study intervention (active or sham injection) at least once.\n\nThe Overall Number of Participants Analyzed differs from the Overall Number of Baseline Participants because only observed cases were used, excluding data after an intercurrent event (ICE) (e.g., stopping intervention or using prohibited medication before Week 36). Missing cases were not included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Central Sub-field Thickness (CST) at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '298', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2q4', 'description': 'Participants received aflibercept 2 mg administered every 4 weeks.'}, {'id': 'OG001', 'title': 'Aflibercept 8q8/3', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 3 initial injections at 4-week intervals.'}, {'id': 'OG002', 'title': 'Aflibercept 8q8/5', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 5 initial injections at 4-week intervals.'}], 'classes': [{'categories': [{'measurements': [{'value': '-370.8', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '-370.9', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '-369.5', 'spread': '2.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9804', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-10.0', 'ciUpperLimit': '9.8', 'pValueComment': 'Nominal p-value for the two-sided test.', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond ICE (premature discontinuation of treatment, prohibited medication, missing injection) were censored. Missing/censored data was handled implicitly by MMRM.', 'groupDescription': '8q8/3 - 2q4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline CST measurement was used as a covariate and treatment group, visit, and the stratification variables as fixed factors.', 'nonInferiorityComment': 'Two-sided test (alpha = 0.05)'}, {'pValue': '0.7863', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '-7.7', 'ciUpperLimit': '10.2', 'pValueComment': 'Nominal p-value for the two-sided test.', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond ICE (premature discontinuation of treatment, prohibited medication, missing injection) were censored. Missing/censored data was handled implicitly by MMRM.', 'groupDescription': '8q8/5 - 2q4', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline CST measurement was used as a covariate and treatment group, visit, and the stratification variables as fixed factors.', 'nonInferiorityComment': 'Two-sided test (alpha = 0.05)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Week 36', 'unitOfMeasure': 'μm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): All participants randomly assigned to study intervention who were exposed to study intervention (active or sham injection) at least once.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in NEI VFQ 25 Total Score at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '298', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2q4', 'description': 'Participants received aflibercept 2 mg administered every 4 weeks.'}, {'id': 'OG001', 'title': 'Aflibercept 8q8/3', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 3 initial injections at 4-week intervals.'}, {'id': 'OG002', 'title': 'Aflibercept 8q8/5', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 5 initial injections at 4-week intervals.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.27', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '5.91', 'spread': '0.61', 'groupId': 'OG001'}, {'value': '6.92', 'spread': '0.63', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.6869', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '1.40', 'pValueComment': 'Nominal p-value for the two-sided test.', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond ICE (premature discontinuation of treatment, prohibited medication, missing active injection) were censored. Missing/censored data was imputed by LOCF approach.', 'groupDescription': '8q8/3 - 2q4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline NEI-VFQ-25 total score measurement used as a covariate and treatment group, visit, and stratification variables as fixed factors.', 'nonInferiorityComment': 'Two-sided test (alpha = 0.05)'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '2.45', 'estimateComment': 'Estimation mainly based on hypothetical strategy, i.e. observed data beyond ICE (premature discontinuation of treatment, prohibited medication, missing active injection) were censored. Missing/censored data was imputed by LOCF approach.', 'groupDescription': '8q8/5 - 2q4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Baseline NEI-VFQ-25 total score measurement used as a covariate and treatment group, visit, and stratification variables as fixed factors.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Week 36', 'description': 'NEI-VFQ-25: National Eye Institute Visual Functioning Questionnaire-25; The NEI VFQ-25 total score ranges from 0 to 100. A higher score means a better outcome (better patient-reported visual function).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): All participants randomly assigned to study intervention who were exposed to study intervention (active or sham injection) at least once.'}, {'type': 'SECONDARY', 'title': 'Participants Dosed Only Q8 Through Week 36 in the 8 mg Q8 Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}, {'value': '551', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 8q8/3', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 3 initial injections at 4-week intervals.'}, {'id': 'OG001', 'title': 'Aflibercept 8q8/5', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 5 initial injections at 4-week intervals.'}, {'id': 'OG002', 'title': 'All Aflibercept 8 mg', 'description': 'Pooled aflibercept 8 mg administered every 8 weeks, after 3 or 5 initial injections at 4-week intervals.'}], 'classes': [{'categories': [{'measurements': [{'value': '246', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}, {'value': '501', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Week 36', 'description': 'Number of participants in the aflibercept 8q8/3 and the aflibercept 8q8/5 groups who were able to maintain every 8 weeks (Q8) dosing through Week 36. Only participants who did not discontinue study intervention prior to Week 36, and were therefore considered "completers" for Week 36, were included in the analysis of this endpoint.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF: All participants randomly assigned to study intervention who were exposed to study intervention (active or sham injection) at least once. Analysis of the SAF was performed according to the treatment the participant actually received (as treated).\n\nThe Overall Number of Participants Analyzed is not consistent with numbers provided in the Overall Number of Baseline Participants because only participants considered as completers for Week 36 were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Through Weeks 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '293', 'groupId': 'OG001'}, {'value': '298', 'groupId': 'OG002'}, {'value': '591', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2q4', 'description': 'Participants received aflibercept 2 mg administered every 4 weeks.'}, {'id': 'OG001', 'title': 'Aflibercept 8q8/3', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 3 initial injections at 4-week intervals.'}, {'id': 'OG002', 'title': 'Aflibercept 8q8/5', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 5 initial injections at 4-week intervals.'}, {'id': 'OG003', 'title': 'All Aflibercept HD', 'description': 'Pooled aflibercept 8 mg administered every 8 weeks, after 3 or 5 initial injections at 4-week intervals.'}], 'classes': [{'title': 'Number of participants with TEAEs', 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}, {'value': '360', 'groupId': 'OG003'}]}]}, {'title': 'Number of participants with TESAEs', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Week 36', 'description': 'TEAEs were defined as AEs that occurred in the time frame from first injection (active or sham) to the last injection (active or sham) plus 30 days. Ocular TEAEs in study eye and non-ocular TEAEs are included (ocular TEAEs in fellow eye are excluded)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAF): All participants randomly assigned to study intervention who were exposed to study intervention (active or sham injection) at least once. Analysis of the SAF was performed according to the treatment the participant actually received (as treated).'}, {'type': 'SECONDARY', 'title': 'Systemic Exposure to Aflibercept as Assessed by Plasma Concentrations of Free, Adjusted Bound and Total Aflibercept From Baseline Through Weeks 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}, {'value': '294', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Aflibercept 2q4', 'description': 'Participants received aflibercept 2 mg administered every 4 weeks.'}, {'id': 'OG001', 'title': 'Aflibercept 8q8/3', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 3 initial injections at 4-week intervals.'}, {'id': 'OG002', 'title': 'Aflibercept 8q8/5', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 5 initial injections at 4-week intervals.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}, {'value': '282', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '91.6', 'spread': '55.82', 'groupId': 'OG000'}, {'value': '281.8', 'spread': '52.16', 'groupId': 'OG001'}, {'value': '270.7', 'spread': '63.78', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}, {'value': '276', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '151.5', 'spread': '56.99', 'groupId': 'OG000'}, {'value': '451.7', 'spread': '58.83', 'groupId': 'OG001'}, {'value': '452.6', 'spread': '57.04', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}, {'value': '268', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '241.6', 'spread': '48.40', 'groupId': 'OG000'}, {'value': '470.5', 'spread': '58.24', 'groupId': 'OG001'}, {'value': '729.0', 'spread': '43.82', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '268', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '165.6', 'spread': '58.72', 'groupId': 'OG000'}, {'value': '179.8', 'spread': '73.07', 'groupId': 'OG001'}, {'value': '202.5', 'spread': '80.94', 'groupId': 'OG002'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '167.8', 'spread': '58.81', 'groupId': 'OG000'}, {'value': '366.0', 'spread': '57.87', 'groupId': 'OG001'}, {'value': '313.8', 'spread': '97.30', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From baseline through Week 36', 'description': 'Total aflibercept is the sum of free and adjusted bound aflibercept.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set (PKS): All participants randomly assigned to study intervention with at least one non-missing PK result after the first dose of study intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aflibercept 2q4', 'description': 'Participants received aflibercept 2 mg administered every 4 weeks.'}, {'id': 'FG001', 'title': 'Aflibercept 8q8/3', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 3 initial injections at 4-week intervals.'}, {'id': 'FG002', 'title': 'Aflibercept 8q8/5', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 5 initial injections at 4-week intervals.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '301'}, {'groupId': 'FG001', 'numSubjects': '293'}, {'groupId': 'FG002', 'numSubjects': '298'}]}, {'type': 'COMPLETED', 'comment': 'Completed study until Week 36 (primary completion date)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '287'}, {'groupId': 'FG001', 'numSubjects': '278'}, {'groupId': 'FG002', 'numSubjects': '273'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'No information was available on whether follow-up was completed or not', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The study was conducted at 237 centers in Europe, America, Japan, and Asia-Pacific between 15-May-2023 (first participant first visit) and 07-Nov-2024 (primary completion date).', 'preAssignmentDetails': 'In total 1282 participants were screened, of whom 388 participants were screen failures. Overall, 892 participants were randomized and treated. Of these, 838 participants completed the treatment phase through Week 36 (primary completion date).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '293', 'groupId': 'BG001'}, {'value': '298', 'groupId': 'BG002'}, {'value': '892', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Aflibercept 2q4', 'description': 'Participants received aflibercept 2 mg administered every 4 weeks.'}, {'id': 'BG001', 'title': 'Aflibercept 8q8/3', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 3 initial injections at 4-week intervals.'}, {'id': 'BG002', 'title': 'Aflibercept 8q8/5', 'description': 'Participants received aflibercept 8 mg administered every 8 weeks, after 5 initial injections at 4-week intervals.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.9', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '65.8', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '65.8', 'spread': '11.5', 'groupId': 'BG002'}, {'value': '65.9', 'spread': '11.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}, {'value': '426', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '466', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '267', 'groupId': 'BG000'}, {'value': '254', 'groupId': 'BG001'}, {'value': '273', 'groupId': 'BG002'}, {'value': '794', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian or Alaskan Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '289', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Multiple', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '178', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}, {'value': '528', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-07', 'size': 992788, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-11-03T09:01', 'hasProtocol': True}, {'date': '2024-11-21', 'size': 1196809, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-11-03T09:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 892}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2023-04-28', 'resultsFirstSubmitDate': '2025-11-03', 'studyFirstSubmitQcDate': '2023-04-28', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-03', 'studyFirstPostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 36', 'timeFrame': 'At Week 36', 'description': 'BCVA: Best-Corrected Visual Acuity; ETDRS: Early Treatment Diabetic Retinopathy Study; ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity)'}], 'secondaryOutcomes': [{'measure': 'Number of Active Injections From Baseline to Week 36', 'timeFrame': 'From baseline to Week 36', 'description': 'Active injections refer to the number of injections that were actually administered, as opposed to the number of planned injections.'}, {'measure': 'Participants Gaining at Least 15 Letters in BCVA From Baseline at Week 36', 'timeFrame': 'From baseline at Week 36'}, {'measure': 'Participants Achieving an ETDRS Letter Score of at Least 69 (Approximate 20/40 Snellen Equivalent) at Week 36', 'timeFrame': 'At Week 36', 'description': 'ETDRS letter score (ranging from 0 to 100 letters). A higher letter score means a better outcome (better visual acuity)'}, {'measure': 'Participants Having no Intraretinal Fluid (IRF) and no Sub-retinal Fluid (SRF) in the Center Subfield at Week 36', 'timeFrame': 'At Week 36', 'description': 'Number of participants with no retinal fluid (no IRF and no SRF) in the central subfield at Week 36'}, {'measure': 'Change From Baseline in Central Sub-field Thickness (CST) at Week 36', 'timeFrame': 'From baseline to Week 36'}, {'measure': 'Change From Baseline in NEI VFQ 25 Total Score at Week 36', 'timeFrame': 'From baseline to Week 36', 'description': 'NEI-VFQ-25: National Eye Institute Visual Functioning Questionnaire-25; The NEI VFQ-25 total score ranges from 0 to 100. A higher score means a better outcome (better patient-reported visual function).'}, {'measure': 'Participants Dosed Only Q8 Through Week 36 in the 8 mg Q8 Group', 'timeFrame': 'Through Week 36', 'description': 'Number of participants in the aflibercept 8q8/3 and the aflibercept 8q8/5 groups who were able to maintain every 8 weeks (Q8) dosing through Week 36. Only participants who did not discontinue study intervention prior to Week 36, and were therefore considered "completers" for Week 36, were included in the analysis of this endpoint.'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Through Weeks 36', 'timeFrame': 'Through Week 36', 'description': 'TEAEs were defined as AEs that occurred in the time frame from first injection (active or sham) to the last injection (active or sham) plus 30 days. Ocular TEAEs in study eye and non-ocular TEAEs are included (ocular TEAEs in fellow eye are excluded)'}, {'measure': 'Systemic Exposure to Aflibercept as Assessed by Plasma Concentrations of Free, Adjusted Bound and Total Aflibercept From Baseline Through Weeks 36', 'timeFrame': 'From baseline through Week 36', 'description': 'Total aflibercept is the sum of free and adjusted bound aflibercept.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Macular Edema Secondary to Retinal Vein Occlusion']}, 'referencesModule': {'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': 'Researchers are looking for a better way to treat people who have macular edema secondary to retinal vein occlusion (RVO).\n\nIn people with RVO, a blood vessel that carries blood away from the retina (vein) becomes blocked. The retina is the very back part of the eye. The blocked vein causes fluid and blood to leak into the retina and thereby causes a swelling of the macula (the center of the retina responsible for fine vision). This swelling is called macular edema.\n\nWhen a vein in the retina is blocked, the levels of a protein called vascular endothelial growth factor (VEGF) rises. VEGF helps the growth of new blood vessels. This can lead to macular edema and may cause the vision to become blurry.\n\nThe study treatment intravitreal (IVT) aflibercept is given as an injection into the eye. It works by blocking VEGF and this can help repair vision problems related to RVO. IVT aflibercept is already available and is prescribed by doctors as the standard of care treatment for macula edema secondary to RVO. Standard of care is a treatment that medical experts consider most appropriate for a disease.\n\nStandard of care is given every 4 weeks in people with macula edema secondary to RVO. While repeated injections of aflibercept may prevent worsening of vision, it may place a burden on the patient. However, a higher amount (8 mg) compared to the standard of care (2 mg) of IVT aflibercept is being tested in studies. This higher amount could be given less often. The amount of IVT aflibercept given is measured in milligrams, also known as mg.\n\nThe main purpose of this study is to learn how well a higher amount of the study treatment aflibercept works in people with macular edema secondary to RVO. To answer this, researchers will measure changes in vision called best corrected visual acuity (BCVA) in the study participants between study start and after 36 weeks of treatment. Changes will then be compared between those participants who received the higher amount of IVT aflibercept and those that received standard of care.\n\nTo learn how safe the study treatment is in the participants, the researchers will count the number of participants from study start and up to 64 weeks later that have:\n\n* adverse events\n* serious adverse events\n\n"Adverse events" are any medical problems that the participants have during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think they might be related to the study treatments. An adverse event is considered "serious" when it leads to death, puts the participants\' lives at risk, requires hospitalization, causes disability, causes a baby being born with medical problems or is otherwise medically important.\n\nDependent on the treatment group, the participants will either receive the higher amount of aflibercept or standard of care as an intravitreal injection for up to 60 weeks. The study will consist of a test (screening) phase, a treatment phase and an end of study phase. Each participant will be in the study for up to 64 weeks.\n\nOne visit to the study site is planned during the screening phase, followed by visits approximately every 4 weeks (16 in total) during treatment and one visit at the end of the study.\n\nDuring the study, the study doctors and their team will:\n\n* check patients\' eye health using various eye examination techniques\n* measure patients\' eye vision (BCVA)\n* take blood and urine samples\n* do physical examinations\n* check vital signs\n* examine heart health using electrocardiogram (ECG)\n* do pregnancy tests in women of childbearing age\n\nIn addition, participants will be asked to fill a questionnaire on vision-related quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult ≥18 years of age (or country's legal age of adulthood if the legal age is \\>18 years) at the time of signing the informed consent.\n* Treatment-naïve macular edema involving the foveal center secondary to RVO (BRVO, HRVO, or CRVO) diagnosed within 16 weeks (112 days) before the screening visit in the study eye.\n* Early Treatment Diabetic Retinopathy Study BCVA letter score of 73 to 24 (20/40 to 20/320) at screening and baseline visits in the study eye.\n\nDecrease in BCVA determined to be primarily the result of RVO in the study eye.\n\n* Mean CST ≥300 μm on optical coherence tomography (OCT) if excluding Bruch's membrane (e.g., Cirrus or Topcon) or ≥320 μm if including Bruch's membrane (e.g., Heidelberg Spectralis), confirmed by the reading center at the screening visit and by the site at baseline visit in the study eye.\n* Capable of giving signed informed consent form (ICF) by study participant or legally acceptable representative, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n* US participants will be required to have a Health Insurance Portability and Accountability Act (HIPAA) authorization; in other countries, as applicable according to national laws.\n* Women of childbearing potential (WOCBP) or men who are sexually active with partners of childbearing potential must agree to use highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 4 months after the last administration of study intervention. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for participation in clinical studies and fulfil the conditions set on Section 10.4.2.\n\nExclusion Criteria:\n\n* Concurrent disease that causes substantial decrease of BCVA, is expected to limit BCVA recovery or is likely to require medical or surgical intervention during the study in the study eye.\n* Presence or history of the following ocular conditions:\n\n 1. Advanced age-related macular degeneration (neovascular AMD or geographic atrophy) in the study eye.\n 2. Diabetic macular edema or diabetic retinopathy, defined in diabetic participants as diabetic retinopathy lesions outside the area of the vein occlusion in the study eye and anywhere in the retina in the fellow eye.\n 3. Anterior segment neovascularization, vitreous hemorrhage, retinal detachment in the study eye.\n 4. Vitreomacular traction, epiretinal membrane or structural damage to the macula that is considered by the Investigator to significantly affect central vision or preclude improvement in vision in the study eye.\n 5. Macular hole of stage 2 and above in the study eye.\n 6. Myopia of a spherical equivalent of at least 8 diopters prior to any refractive or cataract surgery in the study eye.\n 7. Corneal transplant or corneal dystrophy in the study eye.\n 8. Idiopathic or autoimmune uveitis in the study or in the fellow eye.\n* Presence of the following ocular conditions at screening or baseline visit:\n\n 1. Significant media opacities, including cataract, that interfere with BCVA, or imaging assessments (e.g., fundus photography \\[FP\\], OCT) in the study eye.\n 2. Aphakia, or pseudophakia with absence of posterior capsule (unless it occurred as a result of a yttrium-aluminum-garnet \\[YAG\\] posterior capsulotomy performed more than 30 days before the screening visit), in the study eye.\n 3. Uncontrolled glaucoma (defined as IOP \\>25 mmHg despite treatment with anti-glaucoma medication); or history or likely future need of glaucoma surgery in the study eye.\n 4. Intraocular inflammation/infection (including trace, or above, cells in the anterior chamber and/or vitreous) within 12 weeks (84 days) of the screening visit in the study or in the fellow eye.\n 5. Extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in the study or in the fellow eye.\n* Uncontrolled blood pressure (defined as systolic \\>160 mmHg or diastolic \\>95 mmHg) at the screening visit or baseline visit.\n* Uncontrolled diabetes mellitus, defined by hemoglobin A1c (HbA1c) \\>12% at the screening visit.\n* History of cerebrovascular accident or myocardial infarction within 24 weeks (168 days) before the screening visit or between screening and baseline visits.\n* Renal failure requiring dialysis, or renal transplant at screening or potentially during the study.\n* Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti-VEGF or other agent) or surgery for RVO in the study eye.\n* Previous administration of systemic anti-angiogenic medications for any condition.\n* Prior treatment of the study eye with any of the following drugs (any route of ophthalmic administration) or procedures:\n\n 1. Anti-angiogenic drugs at any time including investigational therapy (e.g., with anti-angiopoietin/anti-VEGF bispecific monoclonal antibodies).\n 2. Previous use topical steroids within 4 weeks (28 days) from the screening visit, or intraocular or periocular steroids within 16 weeks (112 days) from the screening visit, or steroid implants at any time.\n 3. Previous treatment with intraocular or periocular implant, gene therapy, or cell therapy at any time.\n 4. Treatment with ocriplasmin at any time.\n 5. Vitreoretinal surgery (including scleral buckling) at any time.\n 6. Any intraocular surgery, including cataract surgery, within 12 weeks (84 days) before the screening visit.\n 7. Previous treatment with retinal laser photocoagulation.\n* Prior treatment of the fellow eye with any of the following:\n\n a. Gene therapy, or cell therapy in the fellow eye at any time.\n* Participation in other clinical studies requiring administration of investigational treatments (other than vitamins and minerals) at the time of screening visit, or within 30 days or 5 half-lives of administration of the previous study intervention, whichever is longer."}, 'identificationModule': {'nctId': 'NCT05850520', 'acronym': 'QUASAR', 'briefTitle': 'A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of Aflibercept 8 mg in Macular Edema Secondary to Retinal Vein Occlusion', 'orgStudyIdInfo': {'id': '22153'}, 'secondaryIdInfos': [{'id': '2022-502174-16-00', 'type': 'OTHER', 'domain': 'CTIS (EU)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Higher Dose Regimen 1', 'description': 'Higher dose of aflibercept is administered with initial initiation doses intervals, followed by extension of treatment intervals and further adjustment of intervals according to treatment response.', 'interventionNames': ['Drug: Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose', 'Drug: Sham', 'Diagnostic Test: Fluorescein']}, {'type': 'EXPERIMENTAL', 'label': 'Higher Dose Regimen 2', 'description': 'Higher dose of aflibercept is administered with initial initiation doses intervals, followed by extension of treatment intervals and further adjustment of intervals according to treatment response.', 'interventionNames': ['Drug: Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose', 'Drug: Sham', 'Diagnostic Test: Fluorescein']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care', 'description': 'Aflibercept 2 mg is administered by standard treatment intervals, followed by adjustment of treatment intervals according to treatment response.', 'interventionNames': ['Drug: Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_2 mg', 'Diagnostic Test: Fluorescein']}], 'interventions': [{'name': 'Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose', 'type': 'DRUG', 'description': 'Intravitreally (IVT) injection.', 'armGroupLabels': ['Higher Dose Regimen 1', 'Higher Dose Regimen 2']}, {'name': 'Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_2 mg', 'type': 'DRUG', 'description': 'Intravitreally (IVT) injection.', 'armGroupLabels': ['Standard of care']}, {'name': 'Sham', 'type': 'DRUG', 'description': 'Sham procedure will be given on visits when an active injection is not planned.', 'armGroupLabels': ['Higher Dose Regimen 1', 'Higher Dose Regimen 2']}, {'name': 'Fluorescein', 'type': 'DIAGNOSTIC_TEST', 'description': 'Fluorescein 100 mg/mL solution for injection is a dye that makes the retinal vessels visible during FA examinations, and as such, it will be used as an auxiliary medicinal product (AxMP) in this periodic ophthalmic examination. This medicine is for diagnostic use only. It is not used to treat any condition.', 'armGroupLabels': ['Higher Dose Regimen 1', 'Higher Dose Regimen 2', 'Standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Retina Consultants of Orange County - Fullerton', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90807', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'South Coast Retina - Long Beach', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Northern California Retina Vitreous Associates - Mountain View Office', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Desert Retina Consultants - Palm Springs Office', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '91107', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Azul Vision Pasadena', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '92374', 'city': 'Redlands', 'state': 'California', 'country': 'United States', 'facility': 'Retina Consultants of Southern California', 'geoPoint': {'lat': 34.05557, 'lon': -117.18254}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Retina Consultants of Southern Colorado, PC', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '06320', 'city': 'New London', 'state': 'Connecticut', 'country': 'United States', 'facility': 'New England Retina Associates', 'geoPoint': {'lat': 41.35565, 'lon': -72.09952}}, {'zip': '33064', 'city': 'Deerfield Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Rand Eye Institute', 'geoPoint': {'lat': 26.31841, 'lon': -80.09977}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'National Ophthalmic Research Institute - 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This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.\n\nInterested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. 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'}}}}