Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2026-02-25 @ 8:15 PM
Study NCT ID:
NCT00486018
Status:
COMPLETED
Last Update Posted:
2017-05-10
First Post:
2007-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion (BRAVO)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008269', 'term': 'Macular Edema'}, {'id': 'D012170', 'term': 'Retinal Vein Occlusion'}, {'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], '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': '6 months', 'description': 'Investigators assessed the occurrence of AE/SAEs at all study visits. Summaries are for the safety-evaluable population and include events regardless of relation to study drug or location (e.g. non-study eye events are included). For each AE/SAE, the number of patients experiencing the event, not the number of occurrences of the event, is reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Sham Injection', 'description': 'Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.', 'otherNumAtRisk': 131, 'otherNumAffected': 115, 'seriousNumAtRisk': 131, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Ranibizumab Injection 0.3 mg', 'description': 'Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.', 'otherNumAtRisk': 134, 'otherNumAffected': 125, 'seriousNumAtRisk': 134, 'seriousNumAffected': 14}, {'id': 'EG002', 'title': 'Ranibizumab Injection 0.5 mg', 'description': 'Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.', 'otherNumAtRisk': 130, 'otherNumAffected': 115, 'seriousNumAtRisk': 130, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Conjunctival Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 80}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 71}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Eye Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Eye Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 21}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Foreign Body Sensation in Eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Maculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 16}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Myodesopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Ocular Hyperemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Ocular Vascular Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Retinal Depigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 15}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Retinal Exudates', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 32}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Retinal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 23}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Retinal Vascular Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 15}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vitreous Detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Intraocular Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gaze Palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Visual Acuity Reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Retinal Ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Retinal Neovascularization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Retinal Vein Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Retinal Detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Retinal Tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Macular Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Colonic Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Small Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Intra-Abdominal Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Rectal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Intestinal Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Endophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lobar Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gastroenteritis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Corneal Abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Post Procedural Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pelvic Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diabetes Mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gastric Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cerebral Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Thalamus Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 131, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 134, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Injection', 'description': 'Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.'}, {'id': 'OG001', 'title': 'Ranibizumab Injection 0.3 mg', 'description': 'Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.'}, {'id': 'OG002', 'title': 'Ranibizumab Injection 0.5 mg', 'description': 'Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '54.7', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '56.0', 'spread': '12.1', 'groupId': 'OG001'}, {'value': '53.0', 'spread': '12.5', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Month 6', 'categories': [{'measurements': [{'value': '7.3', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '16.6', 'spread': '11.0', 'groupId': 'OG001'}, {'value': '18.3', 'spread': '13.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares means', 'ciPctValue': '95', 'paramValue': '9.4', 'ciLowerLimit': '6.6', 'ciUpperLimit': '12.2', 'pValueComment': 'The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares means', 'ciPctValue': '95', 'paramValue': '10.6', 'ciLowerLimit': '7.6', 'ciUpperLimit': '13.6', 'pValueComment': 'The Hochberg-Bonferroni multiple comparison procedure was used to adjust for comparisons of the two ranibizumab groups with the sham-injection group to maintain an overall type I error rate of 0.05.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'BCVA score in the study eye was based on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (randomized) population. Missing values were imputed using the last-observation-carried-forward (LOCF) method.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Gained ≥ 15 Letters in BCVA Score at Month 6 Compared With Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Injection', 'description': 'Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.'}, {'id': 'OG001', 'title': 'Ranibizumab Injection 0.3 mg', 'description': 'Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.'}, {'id': 'OG002', 'title': 'Ranibizumab Injection 0.5 mg', 'description': 'Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000', 'lowerLimit': '21.1', 'upperLimit': '36.5'}, {'value': '55.2', 'groupId': 'OG001', 'lowerLimit': '46.8', 'upperLimit': '63.6'}, {'value': '61.1', 'groupId': 'OG002', 'lowerLimit': '52.7', 'upperLimit': '69.4'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciPctValue': '95', 'paramValue': '26.8', 'ciLowerLimit': '15.6', 'ciUpperLimit': '38.0', 'estimateComment': 'Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.', 'statisticalMethod': 'Cochran-Mantel-Haenszel χ²', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciPctValue': '95', 'paramValue': '31.3', 'ciLowerLimit': '20.1', 'ciUpperLimit': '42.6', 'estimateComment': 'Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.', 'statisticalMethod': 'Cochran-Mantel-Haenszel χ²', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 6 months', 'description': 'BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (randomized) population. Missing values were imputed using the LOCF method.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Lost < 15 Letters in BCVA Score at Month 6 Compared With Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Injection', 'description': 'Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.'}, {'id': 'OG001', 'title': 'Ranibizumab Injection 0.3 mg', 'description': 'Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.'}, {'id': 'OG002', 'title': 'Ranibizumab Injection 0.5 mg', 'description': 'Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000', 'lowerLimit': '90.5', 'upperLimit': '98.0'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.4', 'upperLimit': '100'}, {'value': '98.5', 'groupId': 'OG002', 'lowerLimit': '94.6', 'upperLimit': '99.7'}]}]}], 'analyses': [{'pValue': '0.0141', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciPctValue': '95', 'paramValue': '4.5', 'ciLowerLimit': '1.6', 'ciUpperLimit': '9.9', 'estimateComment': 'Exact confidence interval based on inverting the exact two-sided score test.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2815', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciPctValue': '95', 'paramValue': '3.0', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '8.3', 'estimateComment': 'Exact confidence interval based on inverting the exact two-sided score test.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 6 months', 'description': 'BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters. The percentage of subjects who lost \\<15 letters will be greater than the percentage of subjects who "gained \\>=15 letters" as "losing \\<15 letters" includes both those who gained \\>=15 letters and those who were "stable" (i.e. lost between 1 and 14 letters, had no change, or gained between 1 and 14 letters).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (randomized) population. Missing values were imputed using the LOCF method.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Central Foveal Thickness of ≤ 250 μm at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Injection', 'description': 'Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.'}, {'id': 'OG001', 'title': 'Ranibizumab Injection 0.3 mg', 'description': 'Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.'}, {'id': 'OG002', 'title': 'Ranibizumab Injection 0.5 mg', 'description': 'Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000', 'lowerLimit': '37.0', 'upperLimit': '53.9'}, {'value': '91.0', 'groupId': 'OG001', 'lowerLimit': '86.2', 'upperLimit': '95.9'}, {'value': '84.7', 'groupId': 'OG002', 'lowerLimit': '78.6', 'upperLimit': '90.9'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage', 'ciPctValue': '95', 'paramValue': '45.5', 'ciLowerLimit': '36.0', 'ciUpperLimit': '55.0', 'estimateComment': 'Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.', 'statisticalMethod': 'Cochran-Mantel-Haenszel χ²', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciPctValue': '95', 'paramValue': '40.1', 'ciLowerLimit': '29.9', 'ciUpperLimit': '50.2', 'estimateComment': 'Weighted estimates adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) using Cochran-Mantel-Haenszel weights.', 'statisticalMethod': 'Cochran-Mantel-Haenszel χ²', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters).'}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'A central reading center assessed all optical coherence tomography (OCT) images. Central foveal thickness was defined as the center point thickness.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (randomized) population. Missing values were imputed using the LOCF method.'}, {'type': 'SECONDARY', 'title': 'Mean Absolute Change From Baseline in Central Foveal Thickness at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '131', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Injection', 'description': 'Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.'}, {'id': 'OG001', 'title': 'Ranibizumab Injection 0.3 mg', 'description': 'Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.'}, {'id': 'OG002', 'title': 'Ranibizumab Injection 0.5 mg', 'description': 'Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '488.0', 'spread': '192.2', 'groupId': 'OG000'}, {'value': '522.1', 'spread': '201.9', 'groupId': 'OG001'}, {'value': '551.7', 'spread': '223.5', 'groupId': 'OG002'}]}]}, {'title': 'Mean Absolute Change from Baseline at Month 6', 'categories': [{'measurements': [{'value': '-157.7', 'spread': '224.2', 'groupId': 'OG000'}, {'value': '-337.3', 'spread': '224.4', 'groupId': 'OG001'}, {'value': '-345.2', 'spread': '238.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares means', 'ciPctValue': '95', 'paramValue': '-148.7', 'ciLowerLimit': '-183.6', 'ciUpperLimit': '-113.8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares means', 'ciPctValue': '95', 'paramValue': '-134.8', 'ciLowerLimit': '-172.7', 'ciUpperLimit': '-96.8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline value of central foveal thickness.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'A central reading center assessed all OCT images. Central foveal thickness was defined as the center point thickness.', 'unitOfMeasure': 'μm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (randomized) population. Missing values were imputed using the LOCF method.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Near Activities Subscale Score at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Injection', 'description': 'Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.'}, {'id': 'OG001', 'title': 'Ranibizumab Injection 0.3 mg', 'description': 'Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.'}, {'id': 'OG002', 'title': 'Ranibizumab Injection 0.5 mg', 'description': 'Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '69.6', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '67.9', 'spread': '22.1', 'groupId': 'OG001'}, {'value': '69.4', 'spread': '20.5', 'groupId': 'OG002'}]}]}, {'title': 'Change from baseline at Month 6', 'categories': [{'measurements': [{'value': '7.3', 'spread': '15.3', 'groupId': 'OG000'}, {'value': '12.1', 'spread': '17.3', 'groupId': 'OG001'}, {'value': '13.7', 'spread': '18.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0214', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares means', 'ciPctValue': '95', 'paramValue': '4.1', 'ciLowerLimit': '0.6', 'ciUpperLimit': '7.6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares means', 'ciPctValue': '95', 'paramValue': '6.4', 'ciLowerLimit': '3.0', 'ciUpperLimit': '9.8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Near Activities Subscale score.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A3, A4, and A5 pertained to the Near Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.', 'unitOfMeasure': 'Points on the NEI VFQ-25 subscale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (randomized) population; however, patients without a baseline score were excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Injection', 'description': 'Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.'}, {'id': 'OG001', 'title': 'Ranibizumab Injection 0.3 mg', 'description': 'Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.'}, {'id': 'OG002', 'title': 'Ranibizumab Injection 0.5 mg', 'description': 'Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '76.4', 'spread': '20.6', 'groupId': 'OG000'}, {'value': '76.0', 'spread': '20.5', 'groupId': 'OG001'}, {'value': '76.7', 'spread': '18.1', 'groupId': 'OG002'}]}]}, {'title': 'Mean Change from Baseline at Month 6', 'categories': [{'measurements': [{'value': '6.3', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '17.2', 'groupId': 'OG001'}, {'value': '11.3', 'spread': '16.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0248', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares means', 'ciPctValue': '95', 'paramValue': '3.8', 'ciLowerLimit': '0.5', 'ciUpperLimit': '7.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.'}, {'pValue': '0.0014', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares means', 'ciPctValue': '95', 'paramValue': '5.1', 'ciLowerLimit': '2.0', 'ciUpperLimit': '8.3', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Pairwise ANCOVA models adjusted for baseline visual acuity score (≤ 34, 35-54, ≥ 55 letters) and baseline Distance Activities Subscale score.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A6, A7, and A8 pertained to the Distance Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.', 'unitOfMeasure': 'Points on the NEI-VFQ-25 subscale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (randomized) population; however, patients without a baseline score were excluded from analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sham Injection', 'description': 'Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.'}, {'id': 'FG001', 'title': 'Ranibizumab Injection 0.3 mg', 'description': 'Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.'}, {'id': 'FG002', 'title': 'Ranibizumab Injection 0.5 mg', 'description': 'Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}, {'groupId': 'FG001', 'numSubjects': '134'}, {'groupId': 'FG002', 'numSubjects': '131'}]}, {'type': 'Received Drug (Safety Population)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '134'}, {'groupId': 'FG002', 'numSubjects': '130'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '128'}, {'groupId': 'FG002', 'numSubjects': '125'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Please note that although the table below is titled "Overall Study," the completion rates are for the 6-month Treatment Period only (i.e., does not include the 6-month Observation Period data).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '397', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Sham Injection', 'description': 'Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.'}, {'id': 'BG001', 'title': 'Ranibizumab Injection 0.3 mg', 'description': 'Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.'}, {'id': 'BG002', 'title': 'Ranibizumab Injection 0.5 mg', 'description': 'Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.2', 'spread': '12.7', 'groupId': 'BG000'}, {'value': '66.6', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '67.5', 'spread': '11.8', 'groupId': 'BG002'}, {'value': '66.4', 'spread': '11.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 45 years', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': '45 to < 65 years', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '161', 'groupId': 'BG003'}]}]}, {'title': '65 to < 85 years', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '203', 'groupId': 'BG003'}]}]}, {'title': '≥ 85 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '185', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '212', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 397}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'dispFirstSubmitDate': '2010-05-05', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-04', 'studyFirstSubmitDate': '2007-06-11', 'dispFirstSubmitQcDate': '2010-05-05', 'resultsFirstSubmitDate': '2010-08-16', 'studyFirstSubmitQcDate': '2007-06-11', 'dispFirstPostDateStruct': {'date': '2010-05-07', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-02-01', 'studyFirstPostDateStruct': {'date': '2007-06-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months', 'timeFrame': 'Baseline and 6 months', 'description': 'BCVA score in the study eye was based on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Gained ≥ 15 Letters in BCVA Score at Month 6 Compared With Baseline', 'timeFrame': 'Baseline and 6 months', 'description': 'BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.'}, {'measure': 'Percentage of Participants Who Lost < 15 Letters in BCVA Score at Month 6 Compared With Baseline', 'timeFrame': 'Baseline and 6 months', 'description': 'BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters. The percentage of subjects who lost \\<15 letters will be greater than the percentage of subjects who "gained \\>=15 letters" as "losing \\<15 letters" includes both those who gained \\>=15 letters and those who were "stable" (i.e. lost between 1 and 14 letters, had no change, or gained between 1 and 14 letters).'}, {'measure': 'Percentage of Participants With a Central Foveal Thickness of ≤ 250 μm at Month 6', 'timeFrame': '6 months', 'description': 'A central reading center assessed all optical coherence tomography (OCT) images. Central foveal thickness was defined as the center point thickness.'}, {'measure': 'Mean Absolute Change From Baseline in Central Foveal Thickness at Month 6', 'timeFrame': 'Baseline and 6 months', 'description': 'A central reading center assessed all OCT images. Central foveal thickness was defined as the center point thickness.'}, {'measure': 'Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Near Activities Subscale Score at Month 6', 'timeFrame': 'Baseline and 6 months', 'description': 'The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A3, A4, and A5 pertained to the Near Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.'}, {'measure': 'Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6', 'timeFrame': 'Baseline and 6 months', 'description': 'The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A6, A7, and A8 pertained to the Distance Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.'}]}, 'conditionsModule': {'keywords': ['Lucentis', 'RVO', 'BRVO', 'Edema'], 'conditions': ['Macular Edema', 'Retinal Vein Occlusion']}, 'referencesModule': {'references': [{'pmid': '23699977', 'type': 'DERIVED', 'citation': 'Suner IJ, Bressler NM, Varma R, Lee P, Dolan CM, Ward J, Colman S, Rubio RG. Reading speed improvements in retinal vein occlusion after ranibizumab treatment. JAMA Ophthalmol. 2013 Jul;131(7):851-6. doi: 10.1001/jamaophthalmol.2013.114.'}, {'pmid': '23415775', 'type': 'DERIVED', 'citation': 'Bhisitkul RB, Campochiaro PA, Shapiro H, Rubio RG. Predictive value in retinal vein occlusions of early versus late or incomplete ranibizumab response defined by optical coherence tomography. Ophthalmology. 2013 May;120(5):1057-63. doi: 10.1016/j.ophtha.2012.11.011. Epub 2013 Feb 14.'}]}, 'descriptionModule': {'briefSummary': 'This was a Phase III, multicenter, randomized, double-masked, sham injection-controlled study of the efficacy and safety of intravitreal ranibizumab compared with sham injections in patients with macular edema secondary to branch retinal vein occlusion (BRVO); 397 patients with BRVO were enrolled at 93 investigational sites in the United States. The study included a treatment period (6 months) and an observation period (6 months).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Willingness to provide signed Informed Consent Form\n* Age ≥ 18 years\n* For sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study\n* Ability and willingness to return for all scheduled visits and assessments\n\nOcular Inclusion Criterion (Study Eye):\n\n* Foveal center-involved macular edema secondary to BRVO\n* BCVA using ETDRS charts of 20/40 to 20/400 (Snellen equivalent)\n* Mean central subfield thickness ≥ 250 μm on two optical coherence tomography (OCT) measurements (at screening \\[confirmed by the central reading center\\] and Day 0 \\[confirmed by the evaluating physician\\])\n* Media clarity, pupillary dilation, and participant cooperation sufficient to obtain adequate fundus photographs\n\nExclusion Criteria:\n\n* History of cerebral vascular accident or myocardial infarction within 3 months prior to Day 0\n* History of any anti-vascular endothelial growth factor (VEGF) treatment in fellow eye within 3 months prior to Day 0\n* History of any systemic anti-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 (namely, all active malignancies); history of successfully treated malignancies is not an exclusion criterion\n* Uncontrolled blood pressure\n* Pregnancy or lactation\n* Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g., chronic alcoholism or drug abuse, personality disorder or use of major tranquilizers, indicated difficulty in long-term follow-up, and likelihood of survival of less than 1 year)\n* Participation in an investigational trial within 30 days prior to Day 0 that involved treatment with any drug (excluding vitamins and minerals) or device that has not received regulatory approval at 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 radial optic neurotomy or sheathotomy\n* History or presence of age-related macular degeneration (AMD; dry or wet form)\n* History of any anti-VEGF treatment in the study eye within 3 months prior to Day 0\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 3 months prior to randomization or anticipated within the next 4 months following randomization\n* History of intraocular corticosteroid use within 3 months prior to Day 0\n* History of pars plana vitrectomy\n* History of intraocular surgery (including cataract extraction, scleral buckle, etc.) within 2 months prior to Day 0 or anticipated within the next 7 months following Day 0\n* History of yttrium-aluminum-garnet 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 (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or OCT, thought to be contributing to macular edema\n* An eye that, in the investigator's opinion, would not benefit from resolution of macular edema, such as eyes with foveal atrophy, dense pigmentary changes, or dense subfoveal hard exudates\n* Presence of an ocular condition that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the study (e.g., uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass syndrome, or prior macula-off rhegmatogenous retinal detachment)\n* Visually significant hemorrhage obscuring the fovea and felt to be a major contributor to reduced visual acuity\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 (i.e., a 20/40 cataract)\n* Aphakia\n* Relevant ocular disease that may be associated with increased intraocular VEGF levels (namely, uveitis, neovascular glaucoma, neovascular AMD, diabetic retinopathy, diabetic maculopathy, or ocular ischemic syndrome)\n* Improvement of \\> 10 letters on best corrected visual acuity (BCVA) between screening and Day 0"}, 'identificationModule': {'nctId': 'NCT00486018', 'acronym': 'BRAVO', 'briefTitle': 'A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion (BRAVO)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase III, Multicenter, Randomized, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab Injection Compared With Sham in Subjects With Macular Edema Secondary to Branch Retinal Vein Occlusion', 'orgStudyIdInfo': {'id': 'FVF4165g'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham injection', 'interventionNames': ['Drug: Sham injection']}, {'type': 'EXPERIMENTAL', 'label': 'Ranibizumab injection 0.3 mg', 'interventionNames': ['Drug: Ranibizumab injection 0.3 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Ranibizumab injection 0.5 mg', 'interventionNames': ['Drug: Ranibizumab injection 0.5 mg']}], 'interventions': [{'name': 'Ranibizumab injection 0.3 mg', 'type': 'DRUG', 'otherNames': ['Lucentis'], 'description': 'Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.', 'armGroupLabels': ['Ranibizumab injection 0.3 mg']}, {'name': 'Ranibizumab injection 0.5 mg', 'type': 'DRUG', 'otherNames': ['Lucentis'], 'description': 'Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.', 'armGroupLabels': ['Ranibizumab injection 0.5 mg']}, {'name': 'Sham injection', 'type': 'DRUG', 'description': 'Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.', 'armGroupLabels': ['Sham injection']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Roman Rubio, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}