Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-01 @ 8:36 AM
Study NCT ID:
NCT01599650
Status:
COMPLETED
Last Update Posted:
2016-11-10
First Post:
2012-05-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Turkey (Türkiye)']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012170', 'term': 'Retinal Vein Occlusion'}, {'id': 'D008269', 'term': 'Macular Edema'}, {'id': 'D014786', 'term': 'Vision Disorders'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}, {'id': 'D007834', 'term': 'Lasers'}], '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'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Clinical Disclosure Office', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '[1] Safety set was summarized based on actual treatment received. There were 3 laser monotherapy patients who received ranibizumab and 1 ranibizumab patient who received laser treatment which resulted in percentages > 100% for the ranibizumab + laser arm.', 'eventGroups': [{'id': 'EG000', 'title': 'Ranibizumab 0.5mg', 'description': 'Ranibizumab 0.5mg', 'otherNumAtRisk': 180, 'otherNumAffected': 112, 'seriousNumAtRisk': 180, 'seriousNumAffected': 30}, {'id': 'EG001', 'title': 'Ranibizumab 0.5mg + Laser', 'description': 'Ranibizumab 0.5mg + Laser\n\n\\[1\\] Safety set was summarized based on actual treatment received. There were 3 laser monotherapy patients who received ranibizumab and 1 ranibizumab patient who received laser treatment which resulted in percentages \\> 100% for the ranibizumab + laser arm.', 'otherNumAtRisk': 183, 'otherNumAffected': 121, 'seriousNumAtRisk': 183, 'seriousNumAffected': 33}, {'id': 'EG002', 'title': 'Laser Monotherapy With Ranibizumab 0.5 mg From Month 6', 'description': 'Laser monotherapy with Ranibizumab 0.5 mg from Month 6', 'otherNumAtRisk': 63, 'otherNumAffected': 40, 'seriousNumAtRisk': 63, 'seriousNumAffected': 10}, {'id': 'EG003', 'title': 'Laser Monotherapy Without Ranibizumab 0.5 mg From Month 6', 'description': 'Laser monotherapy without Ranibizumab 0.5 mg from Month 6', 'otherNumAtRisk': 25, 'otherNumAffected': 14, 'seriousNumAtRisk': 25, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blepharitis (Fellow untreated eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blepharitis (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cataract (Fellow untreated eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cataract (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Conjunctival haemorrhage (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Conjunctivitis allergic (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Corneal erosion (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cystoid macular oedema (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dry eye (Fellow untreated eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dry eye (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye irritation (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye pain (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye pruritus (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eyelid oedema (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Glaucoma (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lacrimation increased (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Macular fibrosis (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Macular oedema (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metamorphopsia (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ocular hyperaemia (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ocular hypertension (Fellow untreated eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ocular hypertension (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Photopsia (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Posterior capsule opacification (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Punctate keratitis (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retinal haemorrhage (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retinal ischaemia (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retinal neovascularisation (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retinal vein occlusion (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vision blurred (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Visual acuity reduced (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vitreous adhesions (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vitreous detachment (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vitreous floaters (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vitreous haemorrhage (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Burnout syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Prerenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dermatitis bullous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 180, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1-ranibizumab Monotherapy', 'description': 'laser therapy + Ranibizumab 0.5 mg'}, {'id': 'OG001', 'title': '2-ranibizumab With Laser', 'description': 'Ranibizumab 0.5 mg + laser'}, {'id': 'OG002', 'title': '3-laser Monotherapy', 'description': 'after 6 months, laser patients could be treated with ranibizumab'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '59.5', 'spread': '11.78', 'groupId': 'OG000'}, {'value': '56.6', 'spread': '13.19', 'groupId': 'OG001'}, {'value': '56.8', 'spread': '13.86', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '74.3', 'spread': '12.27', 'groupId': 'OG000'}, {'value': '71.4', 'spread': '14.43', 'groupId': 'OG001'}, {'value': '62.8', 'spread': '14.08', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline atMonth 6', 'categories': [{'measurements': [{'value': '14.8', 'spread': '10.70', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '11.13', 'groupId': 'OG001'}, {'value': '6.0', 'spread': '14.27', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.0', 'ciLowerLimit': '7.3', 'ciUpperLimit': '12.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.41', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.7', 'ciLowerLimit': '5.8', 'ciUpperLimit': '11.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.46', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 Months', 'description': 'Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)\n\n-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 6 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'analysis for change consists of the group that had a baseline and 6 month data point'}, {'type': 'SECONDARY', 'title': 'The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1-ranibizumab Monotherapy', 'description': 'laser therapy + Ranibizumab 0.5 mg'}, {'id': 'OG001', 'title': '2-ranibizumab With Laser', 'description': 'Ranibizumab 0.5 mg + laser'}, {'id': 'OG002', 'title': '3-laser Monotherapy', 'description': 'after 6 months, laser patients could be treated with ranibizumab'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '59.5', 'spread': '11.78', 'groupId': 'OG000'}, {'value': '56.6', 'spread': '13.19', 'groupId': 'OG001'}, {'value': '56.8', 'spread': '13.86', 'groupId': 'OG002'}]}]}, {'title': 'Average Month 1 toMonth 24', 'categories': [{'measurements': [{'value': '74.5', 'spread': '12.11', 'groupId': 'OG000'}, {'value': '72.0', 'spread': '13.56', 'groupId': 'OG001'}, {'value': '65.9', 'spread': '13.24', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '15.0', 'spread': '10.86', 'groupId': 'OG000'}, {'value': '15.4', 'spread': '10.76', 'groupId': 'OG001'}, {'value': '9.1', 'spread': '13.49', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 24 Months', 'description': 'Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. (A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 24. Then, mean average change is calculated as the average of average changes across all patients.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'analysis for change consists of the group that had a baseline and 24 month data point'}, {'type': 'SECONDARY', 'title': 'Number of Ranibizumab Treatments From Day 1 to Month 23 by Treatment Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '1-ranibizumab Monotherapy', 'description': 'laser therapy + Ranibizumab 0.5 mg'}, {'id': 'OG001', 'title': '2-ranibizumab With Laser', 'description': 'Ranibizumab 0.5 mg + laser'}], 'classes': [{'categories': [{'measurements': [{'value': '11.4', 'spread': '5.76', 'groupId': 'OG000'}, {'value': '11.3', 'spread': '6.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 through Month 23', 'description': 'Number of injections provided to the patients during the 23 month period and conducted within FAS with LOCF and observed data.', 'unitOfMeasure': 'treatments', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1-ranibizumab Monotherapy', 'description': 'laser therapy + Ranibizumab 0.5 mg'}, {'id': 'OG001', 'title': '2-ranibizumab With Laser', 'description': 'Ranibizumab 0.5 mg + laser'}, {'id': 'OG002', 'title': '3-laser Monotherapy', 'description': 'after 6 months, laser patients could be treated with ranibizumab'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '59.5', 'spread': '11.78', 'groupId': 'OG000'}, {'value': '56.6', 'spread': '13.19', 'groupId': 'OG001'}, {'value': '56.8', 'spread': '13.86', 'groupId': 'OG002'}]}]}, {'title': 'Average Month 1 to Month 6', 'categories': [{'measurements': [{'value': '72.7', 'spread': '11.49', 'groupId': 'OG000'}, {'value': '69.7', 'spread': '13.38', 'groupId': 'OG001'}, {'value': '61.7', 'spread': '12.66', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '13.2', 'spread': '9.60', 'groupId': 'OG000'}, {'value': '13.2', 'spread': '9.89', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '11.69', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline through Month 6', 'description': 'Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters.(A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 6. Then, mean average change is calculated as the average of average changes across all patients.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1-ranibizumab Monotherapy', 'description': 'laser therapy + Ranibizumab 0.5 mg'}, {'id': 'OG001', 'title': '2-ranibizumab With Laser', 'description': 'Ranibizumab 0.5 mg + laser'}, {'id': 'OG002', 'title': '3-laser Monotherapy', 'description': 'after 6 months, laser patients could be treated with ranibizumab'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '59.5', 'spread': '11.78', 'groupId': 'OG000'}, {'value': '56.6', 'spread': '13.19', 'groupId': 'OG001'}, {'value': '56.8', 'spread': '13.86', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '74.9', 'spread': '12.87', 'groupId': 'OG000'}, {'value': '72.3', 'spread': '15.31', 'groupId': 'OG001'}, {'value': '66.8', 'spread': '13.87', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline Month 12', 'categories': [{'measurements': [{'value': '15.4', 'spread': '12.25', 'groupId': 'OG000'}, {'value': '15.7', 'spread': '13.12', 'groupId': 'OG001'}, {'value': '10.0', 'spread': '14.33', 'groupId': 'OG002'}]}]}, {'title': 'Month 24', 'categories': [{'measurements': [{'value': '75.0', 'spread': '14.65', 'groupId': 'OG000'}, {'value': '73.9', 'spread': '14.59', 'groupId': 'OG001'}, {'value': '68.4', 'spread': '15.26', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline Month 24', 'categories': [{'measurements': [{'value': '15.5', 'spread': '13.91', 'groupId': 'OG000'}, {'value': '17.3', 'spread': '12.61', 'groupId': 'OG001'}, {'value': '11.6', 'spread': '16.09', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12 and Month 24', 'description': 'Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 12 and Month 24 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and were assessed by an ANOVA model.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis set'}, {'type': 'SECONDARY', 'title': 'The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1-ranibizumab Monotherapy', 'description': 'laser therapy + Ranibizumab 0.5 mg'}, {'id': 'OG001', 'title': '2-ranibizumab With Laser', 'description': 'Ranibizumab 0.5 mg + laser'}, {'id': 'OG002', 'title': '3-laser Monotherapy', 'description': 'after 6 months, laser patients could be treated with ranibizumab'}], 'classes': [{'title': 'BCVA improvement of >= 1 lettermonth 6', 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000'}, {'value': '96.1', 'groupId': 'OG001'}, {'value': '63.3', 'groupId': 'OG002'}]}]}, {'title': 'BCVA improvement of >= 1 lettermonth 24', 'categories': [{'measurements': [{'value': '89.4', 'groupId': 'OG000'}, {'value': '93.8', 'groupId': 'OG001'}, {'value': '77.8', 'groupId': 'OG002'}]}]}, {'title': 'BCVA improvement of >= 5 lettersmonth 6', 'categories': [{'measurements': [{'value': '86.1', 'groupId': 'OG000'}, {'value': '88.2', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}]}]}, {'title': 'BCVA improvement of >= 5 lettersmonth 24', 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000'}, {'value': '89.3', 'groupId': 'OG001'}, {'value': '70.0', 'groupId': 'OG002'}]}]}, {'title': 'BCVA improvement of >= 10 lettersmonth 6', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '68.5', 'groupId': 'OG001'}, {'value': '41.1', 'groupId': 'OG002'}]}]}, {'title': 'BCVA improvement of >= 10 lettersmonth 24', 'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000'}, {'value': '75.8', 'groupId': 'OG001'}, {'value': '60.0', 'groupId': 'OG002'}]}]}, {'title': 'BCVA improvement of >= 15 lettersmonth 6', 'categories': [{'measurements': [{'value': '45.0', 'groupId': 'OG000'}, {'value': '47.2', 'groupId': 'OG001'}, {'value': '27.8', 'groupId': 'OG002'}]}]}, {'title': 'BCVA improvement of >= 15 lettersmonth 24', 'categories': [{'measurements': [{'value': '52.8', 'groupId': 'OG000'}, {'value': '59.6', 'groupId': 'OG001'}, {'value': '43.3', 'groupId': 'OG002'}]}]}, {'title': 'BCVA improvement of >= 30 lettersmonth 6', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '9.6', 'groupId': 'OG001'}, {'value': '3.3', 'groupId': 'OG002'}]}]}, {'title': 'BCVA improvement of >= 30 lettersmonth 24', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}, {'value': '14.0', 'groupId': 'OG001'}, {'value': '11.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 6 and Month 24', 'description': 'BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at Month 6 \\& Month 24 as compared with baseline, was assessed by an ANOVA model. Endpoints related to the proportion of patients with BCVA letter gain or loss from Baseline was analyzed via stratified Cochran-Mantel-Haenszel test with stratification based on baseline BCVA (baseline BCVA less than or equal to 39, 40 to 59, greater than or equal to 60 letters, treatment groups).', 'unitOfMeasure': 'percent patients gaining improvement', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1-ranibizumab Monotherapy', 'description': 'laser therapy + Ranibizumab 0.5 mg'}, {'id': 'OG001', 'title': '2-ranibizumab With Laser', 'description': 'Ranibizumab 0.5 mg + laser'}, {'id': 'OG002', 'title': '3-laser Monotherapy', 'description': 'after 6 months, laser patients could be treated with ranibizumab'}], 'classes': [{'title': 'BCVA improvement of ≥ 1 letter', 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}]}]}, {'title': 'BCVA improvement of ≥ 5 letters N', 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}, {'title': 'BCVA improvement of ≥ 10 letters', 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'BCVA improvement of ≥ 15 letters', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'BCVA improvement of ≥ 30 letters', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'BCVA score ≥ 73 letters', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': 'Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and Month 6 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 6 indicates a positive outcome.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1-ranibizumab Monotherapy', 'description': 'laser therapy + Ranibizumab 0.5 mg'}, {'id': 'OG001', 'title': '2-ranibizumab With Laser', 'description': 'Ranibizumab 0.5 mg + laser'}, {'id': 'OG002', 'title': '3-laser Monotherapy', 'description': 'after 6 months, laser patients could be treated with ranibizumab'}], 'classes': [{'title': 'BCVA improvement of ≥ 1 letter', 'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}]}, {'title': 'BCVA improvement of ≥ 5 letters', 'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}]}, {'title': 'BCVA improvement of ≥ 10 letters', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}]}, {'title': 'BCVA improvement of ≥ 15 letters', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'BCVA improvement of ≥ 30 letters', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'BCVA score ≥ 73 letters', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and Month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 24 indicates a positive outcome.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1-ranibizumab Monotherapy', 'description': 'laser therapy + Ranibizumab 0.5 mg'}, {'id': 'OG001', 'title': '2-ranibizumab With Laser', 'description': 'Ranibizumab 0.5 mg + laser'}, {'id': 'OG002', 'title': '3-laser Monotherapy', 'description': 'after 6 months, laser patients could be treated with ranibizumab'}], 'classes': [{'title': 'month 12', 'categories': [{'measurements': [{'value': '-215.9', 'spread': '12.83', 'groupId': 'OG000'}, {'value': '-242.5', 'spread': '14.14', 'groupId': 'OG001'}, {'value': '-203.9', 'spread': '22.22', 'groupId': 'OG002'}]}]}, {'title': 'month 24', 'categories': [{'measurements': [{'value': '-228.1', 'spread': '12.65', 'groupId': 'OG000'}, {'value': '-261.7', 'spread': '15.20', 'groupId': 'OG001'}, {'value': '-232.7', 'spread': '24.38', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12 and Month 24', 'description': 'Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation. Stratification was done based on categories of baseline best corrected visual acuity \\& analysis was based on analysis of variance (ANOVA)', 'unitOfMeasure': 'microns', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Mean Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 6 and Month 24 Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1-ranibizumab Monotherapy', 'description': 'laser therapy + Ranibizumab 0.5 mg'}, {'id': 'OG001', 'title': '2-ranibizumab With Laser', 'description': 'Ranibizumab 0.5 mg + laser'}, {'id': 'OG002', 'title': '3-laser Monotherapy', 'description': 'after 6 months, laser patients could be treated with ranibizumab'}], 'classes': [{'title': 'month 6 composite score', 'categories': [{'measurements': [{'value': '5.6', 'spread': '9.56', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '10.41', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '12.12', 'groupId': 'OG002'}]}]}, {'title': 'month 24 composite score', 'categories': [{'measurements': [{'value': '8.0', 'spread': '11.78', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '11.44', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '14.79', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 6 and 24', 'description': 'The survey consists of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. In this format scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'BCVA (Letters) Mean Average Change From First Ranibizumab Treatment to Month 24 in the Study Eye for Patients Randomized to the Laser Monotherapy Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '3- Laser Monotherapy', 'description': 'laser therapy + Ranibizumab 0.5 mg after Month 6'}], 'classes': [{'title': 'Value at 1st Ranibizumab treatment', 'categories': [{'measurements': [{'value': '61.7', 'spread': '12.21', 'groupId': 'OG000'}]}]}, {'title': 'Average post 1st treatment through Month 24', 'categories': [{'measurements': [{'value': '68.16', 'spread': '11.84', 'groupId': 'OG000'}]}]}, {'title': 'Change from 1st Ranibizumab treatment', 'categories': [{'measurements': [{'value': '6.49', 'spread': '7.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 24', 'description': 'Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)\n\n-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 24 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model.', 'unitOfMeasure': 'BCVA letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1-ranibizumab Monotherapy', 'description': 'laser therapy + Ranibizumab 0.5 mg'}, {'id': 'FG001', 'title': '2-ranibizumab With Laser', 'description': 'Ranibizumab 0.5 mg + laser'}, {'id': 'FG002', 'title': '3-laser Monotherapy', 'description': 'after 6 months, laser patients could be treated with ranibizumab'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '183'}, {'groupId': 'FG001', 'numSubjects': '180'}, {'groupId': 'FG002', 'numSubjects': '92'}]}, {'type': 'Completed 6 Mos', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '170'}, {'groupId': 'FG002', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '161'}, {'groupId': 'FG001', 'numSubjects': '154'}, {'groupId': 'FG002', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Administrative issue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '455', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '1-ranibizumab Monotherapy', 'description': 'laser therapy + Ranibizumab 0.5 mg'}, {'id': 'BG001', 'title': '2-ranibizumab With Laser', 'description': 'Ranibizumab 0.5 mg + laser'}, {'id': 'BG002', 'title': '3-laser Monotherapy', 'description': 'after 6 months, laser patients could be treated with ranibizumab'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.7', 'spread': '10.34', 'groupId': 'BG000'}, {'value': '67.3', 'spread': '10.41', 'groupId': 'BG001'}, {'value': '67.7', 'spread': '9.67', 'groupId': 'BG002'}, {'value': '66.3', 'spread': '10.30', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '229', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '226', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 455}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-21', 'studyFirstSubmitDate': '2012-05-02', 'resultsFirstSubmitDate': '2016-05-26', 'studyFirstSubmitQcDate': '2012-05-14', 'lastUpdatePostDateStruct': {'date': '2016-11-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-09-21', 'studyFirstPostDateStruct': {'date': '2012-05-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO)', 'timeFrame': 'Baseline, 6 Months', 'description': 'Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)\n\n-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 6 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model.'}], 'secondaryOutcomes': [{'measure': 'The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline', 'timeFrame': 'Baseline, 24 Months', 'description': 'Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. (A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 24. Then, mean average change is calculated as the average of average changes across all patients.'}, {'measure': 'Number of Ranibizumab Treatments From Day 1 to Month 23 by Treatment Group', 'timeFrame': 'Day 1 through Month 23', 'description': 'Number of injections provided to the patients during the 23 month period and conducted within FAS with LOCF and observed data.'}, {'measure': 'Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6', 'timeFrame': 'From Baseline through Month 6', 'description': 'Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters.(A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 6. Then, mean average change is calculated as the average of average changes across all patients.'}, {'measure': 'The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24', 'timeFrame': 'Baseline, Month 12 and Month 24', 'description': 'Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 12 and Month 24 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and were assessed by an ANOVA model.'}, {'measure': 'The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit', 'timeFrame': 'Baseline, Month 6 and Month 24', 'description': 'BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at Month 6 \\& Month 24 as compared with baseline, was assessed by an ANOVA model. Endpoints related to the proportion of patients with BCVA letter gain or loss from Baseline was analyzed via stratified Cochran-Mantel-Haenszel test with stratification based on baseline BCVA (baseline BCVA less than or equal to 39, 40 to 59, greater than or equal to 60 letters, treatment groups).'}, {'measure': 'Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye', 'timeFrame': 'Month 6', 'description': 'Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and Month 6 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 6 indicates a positive outcome.'}, {'measure': 'Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye', 'timeFrame': 'Month 24', 'description': 'Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and Month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 24 indicates a positive outcome.'}, {'measure': 'The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm', 'timeFrame': 'Month 12 and Month 24', 'description': 'Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation. Stratification was done based on categories of baseline best corrected visual acuity \\& analysis was based on analysis of variance (ANOVA)'}, {'measure': 'The Mean Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 6 and Month 24 Compared to Baseline', 'timeFrame': 'Months 6 and 24', 'description': 'The survey consists of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. In this format scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score.'}, {'measure': 'BCVA (Letters) Mean Average Change From First Ranibizumab Treatment to Month 24 in the Study Eye for Patients Randomized to the Laser Monotherapy Arm', 'timeFrame': 'Month 24', 'description': 'Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)\n\n-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 24 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Macular Edema, Branch Retinal Vein Occlusion, visual impairment'], 'conditions': ['Branch Retinal Vein Occlusion']}, 'referencesModule': {'references': [{'pmid': '34934034', 'type': 'DERIVED', 'citation': 'Pawloff M, Bogunovic H, Gruber A, Michl M, Riedl S, Schmidt-Erfurth U. SYSTEMATIC CORRELATION OF CENTRAL SUBFIELD THICKNESS WITH RETINAL FLUID VOLUMES QUANTIFIED BY DEEP LEARNING IN THE MAJOR EXUDATIVE MACULAR DISEASES. Retina. 2022 May 1;42(5):831-841. doi: 10.1097/IAE.0000000000003385.'}, {'pmid': '28807635', 'type': 'DERIVED', 'citation': 'Tadayoni R, Waldstein SM, Boscia F, Gerding H, Gekkieva M, Barnes E, Das Gupta A, Wenzel A, Pearce I; BRIGHTER Study Group. Sustained Benefits of Ranibizumab with or without Laser in Branch Retinal Vein Occlusion: 24-Month Results of the BRIGHTER Study. Ophthalmology. 2017 Dec;124(12):1778-1787. doi: 10.1016/j.ophtha.2017.06.027. Epub 2017 Aug 12.'}, {'pmid': '27039022', 'type': 'DERIVED', 'citation': 'Tadayoni R, Waldstein SM, Boscia F, Gerding H, Pearce I, Priglinger S, Wenzel A, Barnes E, Gekkieva M, Pilz S, Mones J; BRIGHTER study group. Individualized Stabilization Criteria-Driven Ranibizumab versus Laser in Branch Retinal Vein Occlusion: Six-Month Results of BRIGHTER. Ophthalmology. 2016 Jun;123(6):1332-44. doi: 10.1016/j.ophtha.2016.02.030. Epub 2016 Mar 30.'}]}, 'descriptionModule': {'briefSummary': 'This study will generate comparative data for 0.5-mg ranibizumab using PRN dosing administered with or without adjunctive laser treatment versus laser photocoagulation (the current standard of care) up to Month 6 in patients with visual impairment due to ME secondary to BRVO. Additionally the results of this study will provide long-term (24-month) safety and efficacy data for ranibizumab, administered with or without adjunctive laser treatment in this indication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent must be obtained before any study assessment is performed\n* Diagnosis of visual impairment exclusively due to ME secondary to BRVO\n* BCVA score at Screening and Baseline between 73 and 19 letters (ETDRS)\n\nExclusion Criteria:\n\n* Pregnant or nursing (lactating) women\n* Stroke or myocardial infarction less than 3 months before Screening\n* Uncontrolled blood pressure defined as systolic value of \\>160 mm Hg or diastolic value of \\>100 mm Hg at Screening or Baseline.\n* Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye\n* Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either eye\n* Neovascularization of the iris or neovascular glaucoma in the study eye\n* Use of any systemic antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline\n* Panretinal laser photocoagulation within 3 months before Baseline or anticipated or scheduled within the next 3 months following Baseline in the study eye\n* Focal or grid laser photocoagulation within 4 months before Baseline in the study eye\n* Use of intra- or periocular corticosteroids (including sub-Tenon) within 3 months before Screening in the study eye\n* Any use of intraocular corticosteroid implants (eg, dexamethasone \\[Ozurdex®\\], fluocinolone acetonide \\[Iluvien®\\]) in the study eye'}, 'identificationModule': {'nctId': 'NCT01599650', 'acronym': 'BRIGHTER', 'briefTitle': 'Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion', 'organization': 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