Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-01-27 @ 5:04 AM
Study NCT ID:
NCT01277302
Status:
COMPLETED
Last Update Posted:
2014-04-23
First Post:
2011-01-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Evaluating Dosing Regimens for Treatment With Intravitreal Ranibizumab Injections in Subjects With Macular Edema Following Retinal Vein Occlusion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008269', 'term': 'Macular Edema'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Genentech, Inc.'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were reported beginning at initiation of study treatment up to 30 days following the last administration of study treatment, study discontinuation, or termination, whichever was earlier.', 'description': 'After this period, only SAEs attributed to prior study treatment were reported. Safety population: All enrolled participants who received at least 1 ranibizumab injection in the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Ranibizumab 0.5 mg Monthly - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.', 'otherNumAtRisk': 85, 'otherNumAffected': 70, 'seriousNumAtRisk': 85, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Ranibizumab 0.5 mg PRN - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.', 'otherNumAtRisk': 86, 'otherNumAffected': 61, 'seriousNumAtRisk': 86, 'seriousNumAffected': 14}, {'id': 'EG002', 'title': 'Ranibizumab 0.5 mg Monthly - Non-randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.', 'otherNumAtRisk': 31, 'otherNumAffected': 18, 'seriousNumAtRisk': 31, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cataract', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cataract cortical', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Conjunctival haemorrhage', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Dry eye', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Eye irritation', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Eye pain', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Eye pruritus', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Macular fibrosis', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Macular hole', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Macular oedema', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Retinal aneurysm', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Retinal depigmentation', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Retinal disorder', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Retinal exudates', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Retinal haemorrhage', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Retinal vascular disorder', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vitreous adhesions', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vitreous detachment', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vitreous floaters', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Intraocular pressure increased', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cataract', 'notes': 'Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Dry eye', 'notes': 'Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Retinal haemorrhage', 'notes': 'Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vitreous detachment', 'notes': 'Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Intestinal infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Non-cardia chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Biliary dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Neck injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Osteolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Periarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Benign lymph node neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Lung squamous cell carcinoma stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Meningioma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Spinal cord neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Macular hole', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Macular oedema', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Visual acuity reduced', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Iridocyclitis', 'notes': 'Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Visual acuity reduced', 'notes': 'Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Trend of Change From Baseline in the Best Corrected Visual Acuity (BCVA) Scores From Month 7 to Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg Monthly - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.'}, {'id': 'OG001', 'title': 'Ranibizumab 0.5 mg PRN - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.'}], 'classes': [{'title': 'Month 7 (n=85, 86)', 'categories': [{'measurements': [{'value': '17.5', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '19.7', 'spread': '12.6', 'groupId': 'OG001'}]}]}, {'title': 'Month 15 (n=80, 82)', 'categories': [{'measurements': [{'value': '18.7', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '21.0', 'spread': '14.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5091', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated interaction effect', 'paramValue': '0.071', 'pValueComment': 'This is the p-value of the treatment by time interaction in the longitudinal model. Analysis was not adjusted for multiple comparisons as there was only 1 comparison. p \\< 0.05 (2-sided) was required for significance.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.107', 'groupDescription': 'The null hypothesis was that there was no difference in the trend of change from Baseline in the visual acuity scores from Month 7 to Month 15 between the 2 treatment groups as assessed by the interaction term of treatment by time in a longitudinal model.', 'statisticalMethod': 'Longitudinal mixed model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis was stratified by disease (BRVO or CRVO), randomization month, and randomization BCVA score category (≤35, \\>35 to ≤50, or \\>50 letters).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 15', 'description': 'BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement. The reported data are the observed changes from Baseline in BCVA at Months 7 and 15. For the statistical analysis, the interaction term of treatment by time in a longitudinal model was used to assess whether there was a difference in the trend of change from Baseline in the visual acuity scores from Month 7 to Month 15 between the 2 randomized treatment groups, Monthly and PRN.', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, randomized: All enrolled participants who received at least 1 ranibizumab injection in the study and were randomized into the Monthly or PRN treatment groups. The analysis was based on observed data without imputation for missing values.'}, {'type': 'SECONDARY', 'title': 'Visual Acuity Change From Previous Month During the Alternate Dose Regimen Period in Subjects Who Met the VA-OCT Stability Criteria at the Previous Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg Monthly - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.'}, {'id': 'OG001', 'title': 'Ranibizumab 0.5 mg PRN - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.'}], 'classes': [{'title': 'Month 8 (n=53, 53)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '11.3', 'groupId': 'OG001'}]}]}, {'title': 'Month 9 (n=49, 40)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '8.6', 'groupId': 'OG001'}]}]}, {'title': 'Month 10 (n=52, 31)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '4.2', 'groupId': 'OG001'}]}]}, {'title': 'Month 11 (n=54, 40)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '4.4', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 (n=46, 44)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '4.4', 'groupId': 'OG001'}]}]}, {'title': 'Month 13 (n=50, 41)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '5.2', 'groupId': 'OG001'}]}]}, {'title': 'Month 14 (n=58, 48)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '6.1', 'groupId': 'OG001'}]}]}, {'title': 'Month 15 (n=56, 42)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '4.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 7 through Month 15', 'description': 'BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement. This outcome measure is not relevant for subjects in the non-randomized group because they never met the VA-OCT stability criteria.', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population, randomized: All enrolled participants who received at least 1 ranibizumab injection in the study and were randomized into the monthly or PRN treatment groups. The analysis was based on observed data without imputation for missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg Monthly - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.'}, {'id': 'OG001', 'title': 'Ranibizumab 0.5 mg PRN - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.'}, {'id': 'OG002', 'title': 'Ranibizumab 0.5 mg Monthly - Non-randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.'}], 'classes': [{'title': 'Month 7 (n=85, 86, 17)', 'categories': [{'measurements': [{'value': '62.4', 'groupId': 'OG000', 'lowerLimit': '52.1', 'upperLimit': '72.7'}, {'value': '67.4', 'groupId': 'OG001', 'lowerLimit': '57.5', 'upperLimit': '77.3'}, {'value': '41.2', 'groupId': 'OG002', 'lowerLimit': '17.8', 'upperLimit': '64.6'}]}]}, {'title': 'Month 15 (n=80, 82, 13)', 'categories': [{'measurements': [{'value': '66.3', 'groupId': 'OG000', 'lowerLimit': '55.9', 'upperLimit': '76.6'}, {'value': '70.7', 'groupId': 'OG001', 'lowerLimit': '60.9', 'upperLimit': '80.6'}, {'value': '46.2', 'groupId': 'OG002', 'lowerLimit': '19.1', 'upperLimit': '73.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 7 to Month 15', 'description': 'BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg Monthly - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.'}, {'id': 'OG001', 'title': 'Ranibizumab 0.5 mg PRN - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.'}, {'id': 'OG002', 'title': 'Ranibizumab 0.5 mg Monthly - Non-randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.'}], 'classes': [{'title': 'Month 7 (n=85, 86, 17)', 'categories': [{'measurements': [{'value': '72.9', 'groupId': 'OG000', 'lowerLimit': '63.5', 'upperLimit': '82.4'}, {'value': '76.7', 'groupId': 'OG001', 'lowerLimit': '67.8', 'upperLimit': '85.7'}, {'value': '47.1', 'groupId': 'OG002', 'lowerLimit': '23.3', 'upperLimit': '70.8'}]}]}, {'title': 'Month 15 (n=80, 82, 13)', 'categories': [{'measurements': [{'value': '71.3', 'groupId': 'OG000', 'lowerLimit': '61.3', 'upperLimit': '81.2'}, {'value': '76.8', 'groupId': 'OG001', 'lowerLimit': '67.7', 'upperLimit': '86.0'}, {'value': '46.2', 'groupId': 'OG002', 'lowerLimit': '19.1', 'upperLimit': '73.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 7 to Month 15', 'description': 'VA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 or better is 69 or more letters correctly read in the EDTRS chart.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg Monthly - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.'}, {'id': 'OG001', 'title': 'Ranibizumab 0.5 mg PRN - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.'}, {'id': 'OG002', 'title': 'Ranibizumab 0.5 mg Monthly - Non-randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.'}], 'classes': [{'title': 'Month 1 (n=85, 86, 29)', 'categories': [{'measurements': [{'value': '12.2', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '10.4', 'groupId': 'OG001'}, {'value': '10.7', 'spread': '14.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 7 (n=85, 86, 17)', 'categories': [{'measurements': [{'value': '17.5', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '19.7', 'spread': '12.6', 'groupId': 'OG001'}, {'value': '14.7', 'spread': '12.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 15 (n=80, 82, 13)', 'categories': [{'measurements': [{'value': '18.7', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '21.0', 'spread': '14.1', 'groupId': 'OG001'}, {'value': '14.5', 'spread': '14.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 1 to Month 15', 'description': 'BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg Monthly - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.'}, {'id': 'OG001', 'title': 'Ranibizumab 0.5 mg PRN - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.'}, {'id': 'OG002', 'title': 'Ranibizumab 0.5 mg Monthly - Non-randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.'}], 'classes': [{'title': 'Month 7 (n=85, 86, 17)', 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000', 'lowerLimit': '96.5', 'upperLimit': '100.0'}, {'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '96.6', 'upperLimit': '100.0'}, {'value': '100.0', 'comment': 'A 95% confidence interval cannot be calculated for the observed percentage of 100%.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 15 (n=80, 82, 13)', 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000', 'lowerLimit': '96.3', 'upperLimit': '100.0'}, {'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '96.4', 'upperLimit': '100.0'}, {'value': '100.0', 'comment': 'A 95% confidence interval cannot be calculated for the observed percentage of 100%.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 7 to Month 15', 'description': 'BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Central Foveal Thickness of ≤ 300 µm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg Monthly - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.'}, {'id': 'OG001', 'title': 'Ranibizumab 0.5 mg PRN - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.'}, {'id': 'OG002', 'title': 'Ranibizumab 0.5 mg Monthly - Non-randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.'}], 'classes': [{'title': 'Month 7 (n=85, 86, 17)', 'categories': [{'measurements': [{'value': '88.2', 'groupId': 'OG000', 'lowerLimit': '81.4', 'upperLimit': '95.1'}, {'value': '94.2', 'groupId': 'OG001', 'lowerLimit': '89.2', 'upperLimit': '99.1'}, {'value': '52.9', 'groupId': 'OG002', 'lowerLimit': '29.2', 'upperLimit': '76.7'}]}]}, {'title': 'Month 15 (n=80, 82, 13)', 'categories': [{'measurements': [{'value': '92.5', 'groupId': 'OG000', 'lowerLimit': '86.7', 'upperLimit': '98.3'}, {'value': '85.4', 'groupId': 'OG001', 'lowerLimit': '77.7', 'upperLimit': '93.0'}, {'value': '38.5', 'groupId': 'OG002', 'lowerLimit': '12.0', 'upperLimit': '64.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 7 to Month 15', 'description': 'Central foveal thickness was assessed monthly in the study eye using spectral-domain optical coherence tomography. Central foveal thickness was computed using the automated Cirrus Review software (DOCTR CZM Cirrus OCT Grader Reading Manual, Version 1.02). All participants in the Monthly and PRN groups had a baseline central foveal thickness \\> 300 µm at baseline.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Central Foveal Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg Monthly - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.'}, {'id': 'OG001', 'title': 'Ranibizumab 0.5 mg PRN - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.'}, {'id': 'OG002', 'title': 'Ranibizumab 0.5 mg Monthly - Non-randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.'}], 'classes': [{'title': 'Month 1 (n=85, 86, 29)', 'categories': [{'measurements': [{'value': '-243.0', 'spread': '172.5', 'groupId': 'OG000'}, {'value': '-214.9', 'spread': '166.7', 'groupId': 'OG001'}, {'value': '-157.9', 'spread': '181.8', 'groupId': 'OG002'}]}]}, {'title': 'Month 7 (n=85, 86, 17)', 'categories': [{'measurements': [{'value': '-279.7', 'spread': '167.4', 'groupId': 'OG000'}, {'value': '-265.2', 'spread': '185.9', 'groupId': 'OG001'}, {'value': '-113.9', 'spread': '184.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 15 (n=80, 82, 13)', 'categories': [{'measurements': [{'value': '-289.9', 'spread': '177.2', 'groupId': 'OG000'}, {'value': '-247.8', 'spread': '207.5', 'groupId': 'OG001'}, {'value': '-93.2', 'spread': '225.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 1 to Month 15', 'description': 'Central foveal thickness was assessed monthly in the study eye using spectral-domain optical coherence tomography. Central foveal thickness was computed using the automated Cirrus Review software (DOCTR CZM Cirrus OCT Grader Reading Manual, Version 1.02). All participants in the Monthly and PRN groups had a baseline central foveal thickness \\> 300 µm at baseline. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.', 'unitOfMeasure': 'µm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Intraretinal Edema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg Monthly - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.'}, {'id': 'OG001', 'title': 'Ranibizumab 0.5 mg PRN - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.'}, {'id': 'OG002', 'title': 'Ranibizumab 0.5 mg Monthly - Non-randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.'}], 'classes': [{'title': 'Month 7 (n=85, 86, 17)', 'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000', 'lowerLimit': '21.9', 'upperLimit': '41.7'}, {'value': '30.2', 'groupId': 'OG001', 'lowerLimit': '20.5', 'upperLimit': '39.9'}, {'value': '100.0', 'comment': 'A 95% confidence interval cannot be calculated for the observed percentage of 100%.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 15 (n=80, 82, 13)', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '15.5', 'upperLimit': '34.5'}, {'value': '32.9', 'groupId': 'OG001', 'lowerLimit': '22.8', 'upperLimit': '43.1'}, {'value': '84.6', 'groupId': 'OG002', 'lowerLimit': '65.0', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 7 to Month 15', 'description': 'The presence of intraretinal edema was defined as the presence of subretinal fluid, cystoid spaces, or central retinal thickness ≥ 300 µm as evaluated in spectral-domain optical coherence tomography images by the Digital Angiography Reading Center, the central reading center. At baseline, all participants in the Monthly and PRN groups had presence of edema.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study. The analysis was based on observed data without imputation for missing values.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ranibizumab 0.5 mg Monthly - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.'}, {'id': 'FG001', 'title': 'Ranibizumab 0.5 mg PRN - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.'}, {'id': 'FG002', 'title': 'Ranibizumab 0.5 mg Monthly - Non-randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.'}], 'periods': [{'title': '7-Month Fixed Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '86'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '86'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Subject Decision to Withdraw', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Subject Required Other Drug Therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Subject Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': '8-Month Alternate Dose Regimen Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '86'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '82'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Subject Decision to Withdraw', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Subject Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Relocation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '202', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Ranibizumab 0.5 mg Monthly - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.'}, {'id': 'BG001', 'title': 'Ranibizumab 0.5 mg PRN - Randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.'}, {'id': 'BG002', 'title': 'Ranibizumab 0.5 mg Monthly - Non-randomized Subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.3', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '65.2', 'spread': '12.8', 'groupId': 'BG001'}, {'value': '66.3', 'spread': '12.3', 'groupId': 'BG002'}, {'value': '66.3', 'spread': '12.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat population: All enrolled participants who received at least 1 ranibizumab injection in the study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-27', 'studyFirstSubmitDate': '2011-01-13', 'resultsFirstSubmitDate': '2013-10-17', 'studyFirstSubmitQcDate': '2011-01-13', 'lastUpdatePostDateStruct': {'date': '2014-04-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-27', 'studyFirstPostDateStruct': {'date': '2011-01-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trend of Change From Baseline in the Best Corrected Visual Acuity (BCVA) Scores From Month 7 to Month 15', 'timeFrame': 'Baseline to Month 15', 'description': 'BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement. The reported data are the observed changes from Baseline in BCVA at Months 7 and 15. For the statistical analysis, the interaction term of treatment by time in a longitudinal model was used to assess whether there was a difference in the trend of change from Baseline in the visual acuity scores from Month 7 to Month 15 between the 2 randomized treatment groups, Monthly and PRN.'}], 'secondaryOutcomes': [{'measure': 'Visual Acuity Change From Previous Month During the Alternate Dose Regimen Period in Subjects Who Met the VA-OCT Stability Criteria at the Previous Month', 'timeFrame': 'Month 7 through Month 15', 'description': 'BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement. This outcome measure is not relevant for subjects in the non-randomized group because they never met the VA-OCT stability criteria.'}, {'measure': 'Percentage of Participants Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline', 'timeFrame': 'Month 7 to Month 15', 'description': 'BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.'}, {'measure': 'Percentage of Participants With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better', 'timeFrame': 'Month 7 to Month 15', 'description': 'VA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 or better is 69 or more letters correctly read in the EDTRS chart.'}, {'measure': 'Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score', 'timeFrame': 'Month 1 to Month 15', 'description': 'BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision. A positive change score indicates improvement.'}, {'measure': 'Percentage of Participants Who Lost < 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline', 'timeFrame': 'Month 7 to Month 15', 'description': 'BCVA was measured in the study eye using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.'}, {'measure': 'Percentage of Participants With a Central Foveal Thickness of ≤ 300 µm', 'timeFrame': 'Month 7 to Month 15', 'description': 'Central foveal thickness was assessed monthly in the study eye using spectral-domain optical coherence tomography. Central foveal thickness was computed using the automated Cirrus Review software (DOCTR CZM Cirrus OCT Grader Reading Manual, Version 1.02). All participants in the Monthly and PRN groups had a baseline central foveal thickness \\> 300 µm at baseline.'}, {'measure': 'Mean Change From Baseline in Central Foveal Thickness', 'timeFrame': 'Month 1 to Month 15', 'description': 'Central foveal thickness was assessed monthly in the study eye using spectral-domain optical coherence tomography. Central foveal thickness was computed using the automated Cirrus Review software (DOCTR CZM Cirrus OCT Grader Reading Manual, Version 1.02). All participants in the Monthly and PRN groups had a baseline central foveal thickness \\> 300 µm at baseline. A decrease in foveal thickness suggests a reduction in macular edema. A negative change score indicates improvement.'}, {'measure': 'Percentage of Participants With Intraretinal Edema', 'timeFrame': 'Month 7 to Month 15', 'description': 'The presence of intraretinal edema was defined as the presence of subretinal fluid, cystoid spaces, or central retinal thickness ≥ 300 µm as evaluated in spectral-domain optical coherence tomography images by the Digital Angiography Reading Center, the central reading center. At baseline, all participants in the Monthly and PRN groups had presence of edema.'}]}, 'conditionsModule': {'conditions': ['Macular Edema']}, 'referencesModule': {'references': [{'pmid': '36646240', 'type': 'DERIVED', 'citation': 'Yiu G, Huang D, Wang Y, Wang Z, Yang M, Haskova Z. Predictors of As-Needed Ranibizumab Injection Frequency in Patients With Macular Edema Following Retinal Vein Occlusion. Am J Ophthalmol. 2023 May;249:74-81. doi: 10.1016/j.ajo.2023.01.004. Epub 2023 Jan 14.'}, {'pmid': '30621653', 'type': 'DERIVED', 'citation': 'Lloyd Clark W, Liu M, Kitchens J, Wang PW, Haskova Z. Baseline characteristics associated with early visual acuity gains after ranibizumab treatment for retinal vein occlusion. BMC Ophthalmol. 2019 Jan 8;19(1):11. doi: 10.1186/s12886-018-1012-y.'}]}, 'descriptionModule': {'briefSummary': 'This was a Phase IV multicenter, randomized, open-label study, with masking of the vision examiner, of the efficacy and safety of intravitreal ranibizumab 0.5 mg in subjects with macular edema following Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO).', 'detailedDescription': 'This study consisted of 2 study periods, a 7-month fixed treatment period, followed by an 8-month alternate dose regimen period. Subjects could receive up to a maximum of 15 monthly injections of ranibizumab 0.5 mg during the study, 7 injections (Day 0 and at 6 monthly visits) in the fixed treatment period and a maximum of 8 injections in the alternate dose regimen period. During the fixed treatment period, subjects received 7 monthly intravitreal ranibizumab 0.5 mg injections. During the alternate dose regimen period, from Month 7 through Month 14, subjects were evaluated monthly to determine whether they achieved the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria. Subjects continued to receive monthly ranibizumab 0.5 mg monthly injections until the VA-OCT stability criteria were first met. Upon meeting the VA-OCT stability criteria for the first time during the alternate dose regimen period, subjects were randomly assigned in a 1:1 ratio to one of 2 dose regimens, the PRN (pro re nata, "as-needed") or the Monthly regimen.\n\nPRN randomized subjects: Subjects received no injection at the randomization visit and at future monthly visits where the VA-OCT stability criteria were met and received a ranibizumab 0.5 mg injection at future monthly visits if the VA-OCT stability criteria were not met.\n\nMonthly randomized subjects: Subjects continued to receive ranibizumab 0.5 mg injections at each monthly visit.\n\nMonthly non-randomized subjects: Subjects who did not meet the VA-OCT stability criteria at any month from Month 7 through Month 14 were not randomized and received 8 monthly intravitreal ranibizumab 0.5 mg injections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* For sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study.\n\nOcular Inclusion Criteria (Study Eye)\n\n* Foveal center-involved macular edema secondary to branch retinal vein occlusion (BRVO) (including hemi-retinal retinal vein occlusion \\[HRVO\\]) or central retinal vein occlusion (CRVO).\n* Best corrected visual acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) charts of 20/40 to 20/320 (Snellen equivalent) in the study eye.\n* Mean central subfield thickness \\> 300 µm on 2 spectral-domain optical coherence tomography measurements (screening and Day 0 \\[first day of treatment\\]).\n\nExclusion Criteria:\n\n* History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0.\n* History of any systemic anti-vascular endothelial growth factor (VEGF) or pro-VEGF treatment within 6 months prior to Day 0.\n* History of allergy to fluorescein.\n* History of allergy to ranibizumab injection or related molecule.\n* Relevant systemic disease that may be associated with increased systemic VEGF levels. History of successfully treated malignancies is not an exclusion criterion.\n* Uncontrolled blood pressure.\n* Pregnancy or lactation.\n* Daily use of oral corticosteroids to treat a chronic condition.\n* Required treatment with injectable corticosteroids to treat a musculoskeletal condition.\n* Participation in an investigational trial within 30 days prior to Day 0 that involved treatment with any drug or device that has not received regulatory approval at the time of study entry.\n\nOcular Exclusion Criteria (Study Eye)\n\n* Prior episode of retinal vein occlusion (RVO).\n* Brisk afferent pupillary defect.\n* History of any previous intravitreal anti-VEGF therapy for RVO in the study eye.\n* History of previous therapeutic treatment for RVO, other than anti-VEGF therapy, within 4 months prior to the screening visit, including any intraocular corticosteroids.\n* History of previous surgical treatment for RVO, including radial optic neurotomy or sheathotomy.\n* History or presence of age-related macular degeneration (AMD) (dry form graded as Age-Related Eye Disease Study \\[AREDS\\] Stage 2 or higher or wet form).\n* History of laser photocoagulation for macular edema within 4 months prior to Day 0.\n* History of panretinal scatter photocoagulation or sector laser photocoagulation within 4 months prior to Day 0 or anticipated within the next 4 months following Day 0.\n* History of pars plana vitrectomy.\n* History of intraocular surgery within 2 months prior to Day 0 or anticipated within the next 7 months following Day 0.\n* History of yttrium-aluminum-garnet (YAG) capsulotomy performed within 2 months prior to Day 0.\n* Previous filtration surgery in the study eye.\n* History of herpetic ocular infection.\n* History of ocular toxoplasmosis.\n* History of rhegmatogenous retinal detachment.\n* History of idiopathic central serous chorioretinopathy.\n* Evidence upon examination of vitreoretinal interface disease either on clinical examination or spectral-domain optical coherence tomography (SD-OCT), thought to be contributing to macular edema.\n* Presence of an ocular condition that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the study.\n* Visually significant hemorrhage obscuring the fovea and felt to be a major contributor to reduced visual acuity. The subject should be followed and when the hemorrhage in the fovea clears to the point that it is no longer a major contributor to reduced visual acuity, the subject may be screened for the study.\n* Presence of a substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more.\n* Intra-ocular pressure (IOP) ≥ 30 mmHg. If a subject's IOP is ≥ 30 mmHg, that subject will be referred for glaucoma treatment and may be re-screened after 1 month.\n* Evidence upon examination of pseudoexfoliation.\n* Aphakia.\n* Evidence upon examination of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis.\n* Evidence upon examination of any diabetic retinopathy, defined as eyes of diabetic patients with more than one microaneurysm outside the area of the vein occlusion (inclusive of both eyes).\n* Other relevant ocular disease that may be associated with increased intraocular VEGF levels.\n* Improvement of ≥ 10 letters on best-corrected visual acuity ETDRS score between screening and Day 0."}, 'identificationModule': {'nctId': 'NCT01277302', 'briefTitle': 'A Study Evaluating Dosing Regimens for Treatment With Intravitreal Ranibizumab Injections in Subjects With Macular Edema Following Retinal Vein Occlusion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Multicenter Randomized Study Evaluating Dosing Regimens for Treatment With Intravitreal Ranibizumab Injections in Subjects With Macular Edema Following Retinal Vein Occlusion', 'orgStudyIdInfo': {'id': 'FVF4967g'}, 'secondaryIdInfos': [{'id': 'ML01296', 'type': 'OTHER', 'domain': 'Hoffmann-La Roche'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ranibizumab 0.5 mg monthly - randomized subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.', 'interventionNames': ['Drug: Ranibizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Ranibizumab 0.5 mg PRN - randomized subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm. No injection was given at the randomization visit. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.', 'interventionNames': ['Drug: Ranibizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Ranibizumab 0.5 mg monthly - non-randomized subjects', 'description': 'Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.', 'interventionNames': ['Drug: Ranibizumab']}], 'interventions': [{'name': 'Ranibizumab', 'type': 'DRUG', 'otherNames': ['Lucentis'], 'description': 'Liquid ranibizumab (10 mg/ml) was supplied in a sterile solution in single-use vials.', 'armGroupLabels': ['Ranibizumab 0.5 mg PRN - randomized subjects', 'Ranibizumab 0.5 mg monthly - non-randomized subjects', 'Ranibizumab 0.5 mg monthly - randomized subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '95973', 'city': 'Chico', 'state': 'California', 'country': 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'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29456', 'city': 'Ladson', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.98573, 'lon': -80.10981}}, {'zip': '29169', 'city': 'West Columbia', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 33.99349, 'lon': -81.07398}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '79606', 'city': 'Abilene', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.44874, 'lon': -99.73314}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77384', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}], 'overallOfficials': [{'name': 'Gary Sternberg, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}