Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT00891735
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2009-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Ranibizumab Administered Monthly or on an As-needed Basis in Patients With Subfoveal Neovascular Age-related Macular Degeneration (HARBOR)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Genentech, Inc.'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were recorded from Baseline (first treatment day) through Month 12.', 'description': 'Safety population: All patients who received at least 1 study treatment. Adverse events reported here include ocular adverse events in the study eye and fellow eye, as well as non-ocular adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Ranibizumab 0.5 mg Monthly', 'description': 'Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.', 'otherNumAtRisk': 274, 'otherNumAffected': 240, 'seriousNumAtRisk': 274, 'seriousNumAffected': 66}, {'id': 'EG001', 'title': 'Ranibizumab 2.0 mg Monthly', 'description': 'Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.', 'otherNumAtRisk': 274, 'otherNumAffected': 243, 'seriousNumAtRisk': 274, 'seriousNumAffected': 54}, {'id': 'EG002', 'title': 'Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])', 'description': "Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.", 'otherNumAtRisk': 275, 'otherNumAffected': 250, 'seriousNumAtRisk': 275, 'seriousNumAffected': 57}, {'id': 'EG003', 'title': 'Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])', 'description': "Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.", 'otherNumAtRisk': 272, 'otherNumAffected': 239, 'seriousNumAtRisk': 272, 'seriousNumAffected': 54}], 'otherEvents': [{'term': 'Age-related macular degeneration', 'notes': 'Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 13}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Conjunctival haemorrhage', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 48}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 41}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Detachment of retinal pigment epithelium', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Eye pain', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 23}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Macular degeneration', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 15}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Retinal haemorrhage', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Vitreous detachment', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 27}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Vitreous floaters', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 17}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 21}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Macular degeneration', 'notes': 'Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Retinal haemorrhage', 'notes': 'Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Vitreous detachment', 'notes': 'Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 13}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hypocoagulable state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Sinus arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Tachyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Age-related macular degeneration', 'notes': 'Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Corneal oedema', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Iridocyclitis', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Macular degeneration', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Macular hole', 'notes': 'Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Retinal artery occlusion', 'notes': 'Study eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Eye 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'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Peripheral embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Endophthalmitis', 'notes': 'Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Visual acuity reduced', 'notes': 'Fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 275, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 272, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}, {'value': '273', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg Monthly', 'description': 'Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.'}, {'id': 'OG001', 'title': 'Ranibizumab 2.0 mg Monthly', 'description': 'Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.'}, {'id': 'OG002', 'title': 'Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])', 'description': "Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally."}, {'id': 'OG003', 'title': 'Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])', 'description': "Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally."}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '14.6', 'groupId': 'OG001'}, {'value': '8.2', 'spread': '13.3', 'groupId': 'OG002'}, {'value': '8.6', 'spread': '13.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 12', 'description': 'BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. A decrease in the BCVA score indicates a worsening of vision. A positive change score indicates improvement.', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.'}, {'type': 'SECONDARY', 'title': 'Number of Ranibizumab Injections up to But Not Including Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}, {'value': '272', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg Monthly', 'description': 'Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.'}, {'id': 'OG001', 'title': 'Ranibizumab 2.0 mg Monthly', 'description': 'Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.'}, {'id': 'OG002', 'title': 'Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])', 'description': "Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally."}, {'id': 'OG003', 'title': 'Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])', 'description': "Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally."}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '7.7', 'spread': '2.7', 'groupId': 'OG002'}, {'value': '6.9', 'spread': '2.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 12', 'unitOfMeasure': 'Injections', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated patients. Observed data were used with no imputation.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) From Baseline at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}, {'value': '273', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg Monthly', 'description': 'Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.'}, {'id': 'OG001', 'title': 'Ranibizumab 2.0 mg Monthly', 'description': 'Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.'}, {'id': 'OG002', 'title': 'Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])', 'description': "Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally."}, {'id': 'OG003', 'title': 'Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])', 'description': "Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally."}], 'classes': [{'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000', 'lowerLimit': '28.9', 'upperLimit': '40.2'}, {'value': '36.1', 'groupId': 'OG001', 'lowerLimit': '30.4', 'upperLimit': '41.8'}, {'value': '30.2', 'groupId': 'OG002', 'lowerLimit': '24.8', 'upperLimit': '35.6'}, {'value': '33.0', 'groupId': 'OG003', 'lowerLimit': '27.4', 'upperLimit': '38.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 12', 'description': 'BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}, {'value': '273', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg Monthly', 'description': 'Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.'}, {'id': 'OG001', 'title': 'Ranibizumab 2.0 mg Monthly', 'description': 'Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.'}, {'id': 'OG002', 'title': 'Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])', 'description': "Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally."}, {'id': 'OG003', 'title': 'Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])', 'description': "Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally."}], 'classes': [{'categories': [{'measurements': [{'value': '52.4', 'groupId': 'OG000', 'lowerLimit': '46.5', 'upperLimit': '58.3'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '44.1', 'upperLimit': '55.9'}, {'value': '46.2', 'groupId': 'OG002', 'lowerLimit': '40.3', 'upperLimit': '52.1'}, {'value': '43.6', 'groupId': 'OG003', 'lowerLimit': '37.7', 'upperLimit': '49.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'VA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 is 14 lines correctly read in the EDTRS chart.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With no Evidence of Fluid From Choroidal Neovascularization (CNV) at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}, {'value': '273', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg Monthly', 'description': 'Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.'}, {'id': 'OG001', 'title': 'Ranibizumab 2.0 mg Monthly', 'description': 'Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.'}, {'id': 'OG002', 'title': 'Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])', 'description': "Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally."}, {'id': 'OG003', 'title': 'Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])', 'description': "Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally."}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '7.7'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '8.6'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '0.9', 'upperLimit': '4.9'}, {'value': '4.8', 'groupId': 'OG003', 'lowerLimit': '2.2', 'upperLimit': '7.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'The presence of fluid from choroidal neovascularization (CNV) was assessed by spectral domain optical coherence tomography (SD-OCT). No evidence of fluid was defined as no subretinal fluid thickness, no cystoid spaces, no intraretinal fluid, no pigment epithelial defect thickness, and average central subfield thickness \\< 270 µm.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Central Foveal Thickness at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}, {'value': '273', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg Monthly', 'description': 'Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.'}, {'id': 'OG001', 'title': 'Ranibizumab 2.0 mg Monthly', 'description': 'Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.'}, {'id': 'OG002', 'title': 'Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])', 'description': "Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally."}, {'id': 'OG003', 'title': 'Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])', 'description': "Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally."}], 'classes': [{'title': 'Day 7', 'categories': [{'measurements': [{'value': '-104.9', 'spread': '130.3', 'groupId': 'OG000'}, {'value': '-84.9', 'spread': '111.3', 'groupId': 'OG001'}, {'value': '-103.5', 'spread': '141.3', 'groupId': 'OG002'}, {'value': '-100.6', 'spread': '123.4', 'groupId': 'OG003'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '-141.5', 'spread': '137.5', 'groupId': 'OG000'}, {'value': '-128.6', 'spread': '133.3', 'groupId': 'OG001'}, {'value': '-132.6', 'spread': '148.2', 'groupId': 'OG002'}, {'value': '-146.0', 'spread': '144.3', 'groupId': 'OG003'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '-152.5', 'spread': '142.4', 'groupId': 'OG000'}, {'value': '-140.3', 'spread': '131.1', 'groupId': 'OG001'}, {'value': '-142.9', 'spread': '141.6', 'groupId': 'OG002'}, {'value': '-156.9', 'spread': '145.0', 'groupId': 'OG003'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '-157.0', 'spread': '143.8', 'groupId': 'OG000'}, {'value': '-147.9', 'spread': '134.3', 'groupId': 'OG001'}, {'value': '-154.5', 'spread': '147.9', 'groupId': 'OG002'}, {'value': '-164.9', 'spread': '144.5', 'groupId': 'OG003'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '-164.0', 'spread': '146.6', 'groupId': 'OG000'}, {'value': '-151.8', 'spread': '143.3', 'groupId': 'OG001'}, {'value': '-142.7', 'spread': '153.6', 'groupId': 'OG002'}, {'value': '-159.7', 'spread': '148.8', 'groupId': 'OG003'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '-162.0', 'spread': '150.0', 'groupId': 'OG000'}, {'value': '-149.2', 'spread': '144.0', 'groupId': 'OG001'}, {'value': '-147.5', 'spread': '151.9', 'groupId': 'OG002'}, {'value': '-159.1', 'spread': '149.6', 'groupId': 'OG003'}]}]}, {'title': 'Month 9', 'categories': [{'measurements': [{'value': '-164.5', 'spread': '151.8', 'groupId': 'OG000'}, {'value': '-153.1', 'spread': '144.8', 'groupId': 'OG001'}, {'value': '-153.5', 'spread': '147.1', 'groupId': 'OG002'}, {'value': '-157.8', 'spread': '155.6', 'groupId': 'OG003'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '-172.0', 'spread': '150.5', 'groupId': 'OG000'}, {'value': '-163.3', 'spread': '142.6', 'groupId': 'OG001'}, {'value': '-161.2', 'spread': '152.3', 'groupId': 'OG002'}, {'value': '-172.4', 'spread': '148.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12', 'description': 'Central foveal thickness was assessed by spectral domain optical coherence tomography (SD-OCT).', 'unitOfMeasure': 'µm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Macular Volume at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}, {'value': '273', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg Monthly', 'description': 'Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.'}, {'id': 'OG001', 'title': 'Ranibizumab 2.0 mg Monthly', 'description': 'Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.'}, {'id': 'OG002', 'title': 'Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])', 'description': "Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally."}, {'id': 'OG003', 'title': 'Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])', 'description': "Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally."}], 'classes': [{'title': 'Day 7', 'categories': [{'measurements': [{'value': '-0.79', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '-0.80', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '-0.72', 'spread': '0.87', 'groupId': 'OG002'}, {'value': '-0.81', 'spread': '0.76', 'groupId': 'OG003'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '-1.26', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '-1.30', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '-1.16', 'spread': '1.03', 'groupId': 'OG002'}, {'value': '-1.38', 'spread': '1.18', 'groupId': 'OG003'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '-1.34', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '-1.49', 'spread': '1.31', 'groupId': 'OG001'}, {'value': '-1.30', 'spread': '1.13', 'groupId': 'OG002'}, {'value': '-1.47', 'spread': '1.25', 'groupId': 'OG003'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '-1.42', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '-1.51', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '-1.43', 'spread': '1.33', 'groupId': 'OG002'}, {'value': '-1.55', 'spread': '1.28', 'groupId': 'OG003'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '-1.42', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '-1.56', 'spread': '1.31', 'groupId': 'OG001'}, {'value': '-1.31', 'spread': '1.24', 'groupId': 'OG002'}, {'value': '-1.48', 'spread': '1.27', 'groupId': 'OG003'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '-1.47', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '-1.61', 'spread': '1.34', 'groupId': 'OG001'}, {'value': '-1.35', 'spread': '1.33', 'groupId': 'OG002'}, {'value': '-1.48', 'spread': '1.36', 'groupId': 'OG003'}]}]}, {'title': 'Month 9', 'categories': [{'measurements': [{'value': '-1.55', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '-1.67', 'spread': '1.34', 'groupId': 'OG001'}, {'value': '-1.35', 'spread': '1.31', 'groupId': 'OG002'}, {'value': '-1.48', 'spread': '1.33', 'groupId': 'OG003'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '-1.54', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '-1.66', 'spread': '1.37', 'groupId': 'OG001'}, {'value': '-1.41', 'spread': '1.36', 'groupId': 'OG002'}, {'value': '-1.49', 'spread': '1.35', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12', 'description': 'Macular volume was assessed by spectral domain optical coherence tomography (SD-OCT).', 'unitOfMeasure': 'mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Total Area of Choroidal Neovascularization (CNV) and Choroidal Neovascular Leakage at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}, {'value': '273', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg Monthly', 'description': 'Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.'}, {'id': 'OG001', 'title': 'Ranibizumab 2.0 mg Monthly', 'description': 'Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.'}, {'id': 'OG002', 'title': 'Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])', 'description': "Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally."}, {'id': 'OG003', 'title': 'Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])', 'description': "Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally."}], 'classes': [{'title': 'Change in the total area of CNV', 'categories': [{'measurements': [{'value': '-2.14', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '-2.42', 'spread': '2.38', 'groupId': 'OG001'}, {'value': '-1.74', 'spread': '2.22', 'groupId': 'OG002'}, {'value': '-1.98', 'spread': '2.39', 'groupId': 'OG003'}]}]}, {'title': 'Change in the total area of CNV leakage', 'categories': [{'measurements': [{'value': '-2.35', 'spread': '2.39', 'groupId': 'OG000'}, {'value': '-2.63', 'spread': '2.34', 'groupId': 'OG001'}, {'value': '-2.01', 'spread': '2.28', 'groupId': 'OG002'}, {'value': '-2.22', 'spread': '2.48', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 12', 'description': 'The total area of choroidal neovascularization (CNV) and choroidal neovascular leakage was assessed with fluorescein angiography (FA). Area was measured in disc area units; 1 disc area unit = 2.54 mm\\^2.', 'unitOfMeasure': 'Disc area units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized patients. Missing data were imputed using the last observation carried forward method.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ranibizumab 0.5 mg Monthly', 'description': 'Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.'}, {'id': 'FG001', 'title': 'Ranibizumab 2.0 mg Monthly', 'description': 'Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.'}, {'id': 'FG002', 'title': 'Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])', 'description': "Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally."}, {'id': 'FG003', 'title': 'Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])', 'description': "Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '275'}, {'groupId': 'FG001', 'numSubjects': '274'}, {'groupId': 'FG002', 'numSubjects': '275'}, {'groupId': 'FG003', 'numSubjects': '273'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '258'}, {'groupId': 'FG001', 'numSubjects': '258'}, {'groupId': 'FG002', 'numSubjects': '263'}, {'groupId': 'FG003', 'numSubjects': '258'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': "Physician's decision to withdraw patient", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': "Patient's decision to withdraw", 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '275', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}, {'value': '273', 'groupId': 'BG003'}, {'value': '1097', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Ranibizumab 0.5 mg Monthly', 'description': 'Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.'}, {'id': 'BG001', 'title': 'Ranibizumab 2.0 mg Monthly', 'description': 'Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.'}, {'id': 'BG002', 'title': 'Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])', 'description': "Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally."}, {'id': 'BG003', 'title': 'Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])', 'description': "Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally."}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '78.8', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '79.3', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '78.5', 'spread': '8.3', 'groupId': 'BG002'}, {'value': '78.3', 'spread': '8.3', 'groupId': 'BG003'}, {'value': '78.7', 'spread': '8.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}, {'value': '651', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}, {'value': '446', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1097}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-11', 'studyFirstSubmitDate': '2009-04-29', 'resultsFirstSubmitDate': '2012-09-18', 'studyFirstSubmitQcDate': '2009-04-29', 'lastUpdatePostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-11', 'studyFirstPostDateStruct': {'date': '2009-05-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12', 'timeFrame': 'Baseline to Month 12', 'description': 'BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. A decrease in the BCVA score indicates a worsening of vision. A positive change score indicates improvement.'}], 'secondaryOutcomes': [{'measure': 'Number of Ranibizumab Injections up to But Not Including Month 12', 'timeFrame': 'Baseline to Month 12'}, {'measure': 'Percentage of Patients Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) From Baseline at Month 12', 'timeFrame': 'Baseline to Month 12', 'description': 'BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.'}, {'measure': 'Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Month 12', 'timeFrame': 'Month 12', 'description': 'VA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 is 14 lines correctly read in the EDTRS chart.'}, {'measure': 'Percentage of Patients With no Evidence of Fluid From Choroidal Neovascularization (CNV) at Month 12', 'timeFrame': 'Month 12', 'description': 'The presence of fluid from choroidal neovascularization (CNV) was assessed by spectral domain optical coherence tomography (SD-OCT). No evidence of fluid was defined as no subretinal fluid thickness, no cystoid spaces, no intraretinal fluid, no pigment epithelial defect thickness, and average central subfield thickness \\< 270 µm.'}, {'measure': 'Change From Baseline in Central Foveal Thickness at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12', 'timeFrame': 'Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12', 'description': 'Central foveal thickness was assessed by spectral domain optical coherence tomography (SD-OCT).'}, {'measure': 'Change From Baseline in Macular Volume at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12', 'timeFrame': 'Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12', 'description': 'Macular volume was assessed by spectral domain optical coherence tomography (SD-OCT).'}, {'measure': 'Change From Baseline in the Total Area of Choroidal Neovascularization (CNV) and Choroidal Neovascular Leakage at Month 12', 'timeFrame': 'Baseline to Month 12', 'description': 'The total area of choroidal neovascularization (CNV) and choroidal neovascular leakage was assessed with fluorescein angiography (FA). Area was measured in disc area units; 1 disc area unit = 2.54 mm\\^2.'}]}, 'conditionsModule': {'keywords': ['Lucentis', 'AMD', 'Age-related macular degeneration', 'Subfoveal neovascular age-related macular degeneration', 'Wet AMD', 'Macular degeneration', 'Ranibizumab'], 'conditions': ['Age-related Macular Degeneration']}, 'referencesModule': {'references': [{'pmid': '39287532', 'type': 'DERIVED', 'citation': 'Tong N, Fan W, Su L, Ebraheem A, Uji A, Marion K, Sadda S. RELATIONSHIP BETWEEN OPTICAL COHERENCE TOMOGRAPHY BIOMARKERS AND NUMBER OF INTRAVITREAL RANIBIZUMAB INJECTIONS IN EYES WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION IN THE HARBOR STUDY. Retina. 2024 Oct 1;44(10):1696-1703. doi: 10.1097/IAE.0000000000004171.'}, {'pmid': '37079518', 'type': 'DERIVED', 'citation': 'Kim S, Stockwell A, Qin H, Gao SS, Sagolla M, Stoilov I, Wuster A, Lai P, Yaspan BL, Jeanne M. Rare CIDEC coding variants enriched in age-related macular degeneration patients with small low-luminance deficit cause lipid droplet and fat storage defects. PLoS One. 2023 Apr 20;18(4):e0280484. doi: 10.1371/journal.pone.0280484. eCollection 2023.'}, {'pmid': '36729084', 'type': 'DERIVED', 'citation': 'Adrean SD, Chaili S, Hill L, Amador-Patarroyo MJ. PATTERNS OF SUBRETINAL AND/OR INTRARETINAL FLUID RECURRENCE IN PATIENTS WHO RECEIVED AS-NEEDED RANIBIZUMAB THERAPY IN THE HARBOR TRIAL. Retina. 2023 Apr 1;43(4):624-631. doi: 10.1097/IAE.0000000000003708. Epub 2022 Dec 21.'}, {'pmid': '36372347', 'type': 'DERIVED', 'citation': 'Staurenghi G, Cozzi M, Sadda S, Hill L, Gune S. Characteristics that Correlate with Macular Atrophy in Ranibizumab-Treated Patients with Neovascular Age-Related Macular Degeneration. Ophthalmol Retina. 2023 Apr;7(4):300-306. doi: 10.1016/j.oret.2022.11.002. Epub 2022 Nov 11.'}, {'pmid': '35654363', 'type': 'DERIVED', 'citation': 'Lally DR, Hill L, Amador-Patarroyo MJ. Subretinal Fluid Resolution and Visual Acuity in Patients with Neovascular Age-Related Macular Degeneration: A HARBOR Post Hoc Analysis. Ophthalmol Retina. 2022 Nov;6(11):1054-1060. doi: 10.1016/j.oret.2022.05.026. Epub 2022 May 30.'}, {'pmid': '35342822', 'type': 'DERIVED', 'citation': "Sheth V, D'Rozario M, Gune S, Blotner S. Fluctuations in central foveal thickness and association with vision outcomes with anti-VEGF therapy for nAMD: HARBOR post hoc analysis. BMJ Open Ophthalmol. 2022 Mar 9;7(1):e000957. doi: 10.1136/bmjophth-2021-000957. eCollection 2022."}, {'pmid': '35239009', 'type': 'DERIVED', 'citation': 'Freund KB, Staurenghi G, Jung JJ, Zweifel SA, Cozzi M, Hill L, Blotner S, Tsuboi M, Gune S. Macular neovascularization lesion type and vision outcomes in neovascular age-related macular degeneration: post hoc analysis of HARBOR. Graefes Arch Clin Exp Ophthalmol. 2022 Aug;260(8):2437-2447. doi: 10.1007/s00417-022-05586-w. Epub 2022 Mar 3.'}, {'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': '34289338', 'type': 'DERIVED', 'citation': 'Holekamp NM, Sadda S, Sarraf D, Guymer R, Hill L, Blotner S, Spicer G, Gune S. Effect of Residual Retinal Fluid on Visual Function in Ranibizumab-Treated Neovascular Age-Related Macular Degeneration. Am J Ophthalmol. 2022 Jan;233:8-17. doi: 10.1016/j.ajo.2021.06.029. Epub 2021 Jul 18.'}, {'pmid': '33331859', 'type': 'DERIVED', 'citation': 'Javaheri M, Hill L, Ghanekar A, Stoilov I. Changes in Treatment-Naive Pigment Epithelial Detachments Associated With the Initial Anti-Vascular Endothelial Growth Factor Injection: A Post Hoc Analysis From the HARBOR Trial. JAMA Ophthalmol. 2021 Feb 1;139(2):219-223. doi: 10.1001/jamaophthalmol.2020.5130.'}, {'pmid': '32402555', 'type': 'DERIVED', 'citation': 'Sadda SR, Abdelfattah NS, Lei J, Shi Y, Marion KM, Morgenthien E, Gune S, Balasubramanian S. Spectral-Domain OCT Analysis of Risk Factors for Macular Atrophy Development in the HARBOR Study for Neovascular Age-Related Macular Degeneration. Ophthalmology. 2020 Oct;127(10):1360-1370. doi: 10.1016/j.ophtha.2020.03.031. Epub 2020 Apr 2.'}, {'pmid': '32387055', 'type': 'DERIVED', 'citation': 'Khurana RN, Chang L, Day BM, Ghanekar A, Stoilov I. Timing of Peak Vision Gains in Patients with Neovascular Age-Related Macular Degeneration Treated with Ranibizumab. Ophthalmol Retina. 2020 Aug;4(8):760-766. doi: 10.1016/j.oret.2020.02.011. Epub 2020 Feb 27.'}, {'pmid': '32374423', 'type': 'DERIVED', 'citation': 'Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 May 5;5(5):CD012208. doi: 10.1002/14651858.CD012208.pub2.'}, {'pmid': '32353536', 'type': 'DERIVED', 'citation': 'Khurana RN, Hill L, Ghanekar A, Gune S. Agreement of Spectral-Domain OCT with Fluorescein Leakage in Neovascular Age-Related Macular Degeneration: Post Hoc Analysis of the HARBOR Study. Ophthalmol Retina. 2020 Nov;4(11):1054-1058. doi: 10.1016/j.oret.2020.04.016. Epub 2020 Apr 28.'}, {'pmid': '31735634', 'type': 'DERIVED', 'citation': 'Patel Y, Miller DM, Fung AE, Hill LF, Rosenfeld PJ. Are Dilated Fundus Examinations Needed for OCT-Guided Retreatment of Exudative Age-Related Macular Degeneration? Ophthalmol Retina. 2020 Feb;4(2):141-147. doi: 10.1016/j.oret.2019.09.006. Epub 2019 Sep 18.'}, {'pmid': '31416763', 'type': 'DERIVED', 'citation': 'Khurana RN, Chang LK, Hill LF, Ghanekar A, Stoilov I. The Value of Prior Response to Anti-Vascular Endothelial Growth Factor for Age-Related Macular Degeneration: A HARBOR Subanalysis. Ophthalmol Retina. 2020 Jan;4(1):13-18. doi: 10.1016/j.oret.2019.06.008. Epub 2019 Jul 5.'}, {'pmid': '31281056', 'type': 'DERIVED', 'citation': 'Nassisi M, Lei J, Abdelfattah NS, Karamat A, Balasubramanian S, Fan W, Uji A, Marion KM, Baker K, Huang X, Morgenthien E, Sadda SR. OCT Risk Factors for Development of Late Age-Related Macular Degeneration in the Fellow Eyes of Patients Enrolled in the HARBOR Study. Ophthalmology. 2019 Dec;126(12):1667-1674. doi: 10.1016/j.ophtha.2019.05.016. Epub 2019 May 29.'}, {'pmid': '31021381', 'type': 'DERIVED', 'citation': 'Hallak JA, de Sisternes L, Osborne A, Yaspan B, Rubin DL, Leng T. Imaging, Genetic, and Demographic Factors Associated With Conversion to Neovascular Age-Related Macular Degeneration: Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2019 Jul 1;137(7):738-744. doi: 10.1001/jamaophthalmol.2019.0868.'}, {'pmid': '27566855', 'type': 'DERIVED', 'citation': 'Sarraf D, London NJ, Khurana RN, Dugel PU, Gune S, Hill L, Tuomi L. Ranibizumab Treatment for Pigment Epithelial Detachment Secondary to Neovascular Age-Related Macular Degeneration: Post Hoc Analysis of the HARBOR Study. Ophthalmology. 2016 Oct;123(10):2213-24. doi: 10.1016/j.ophtha.2016.07.007. Epub 2016 Aug 23.'}, {'pmid': '26541435', 'type': 'DERIVED', 'citation': 'Frenkel RE, Shapiro H, Stoilov I. Predicting vision gains with anti-VEGF therapy in neovascular age-related macular degeneration patients by using low-luminance vision. Br J Ophthalmol. 2016 Aug;100(8):1052-7. doi: 10.1136/bjophthalmol-2015-307575. Epub 2015 Nov 5.'}, {'pmid': '23352196', 'type': 'DERIVED', 'citation': 'Busbee BG, Ho AC, Brown DM, Heier JS, Suner IJ, Li Z, Rubio RG, Lai P; HARBOR Study Group. Twelve-month efficacy and safety of 0.5 mg or 2.0 mg ranibizumab in patients with subfoveal neovascular age-related macular degeneration. Ophthalmology. 2013 May;120(5):1046-56. doi: 10.1016/j.ophtha.2012.10.014. Epub 2013 Jan 23.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase III, multicenter, randomized, double-masked, dose-comparison study of the efficacy and safety of ranibizumab injection administered intravitreally to patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Results are presented for the first 12 months of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study.\n\nOcular Inclusion Criteria (Study Eye)\n\n* Best corrected visual acuity (BCVA), using Early Treatment Diabetic Retinopathy Study (ETDRS) charts, of 20/40-20/320 (Snellen equivalent).\n* Choroidal neovascularization (CNV) lesions with classic CNV component, occult CNV, or with some classic CNV component were permissible.\n* Total area of lesion \\< 12 disc area or 30.48 mm\\^2.\n\nExclusion Criteria:\n\n* History of vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD) in the study eye.\n* Prior treatment with Visudyne(R), external-beam radiation therapy, or transpupillary thermotherapy (TTT) in the study eye.\n* Previous intravitreal drug delivery (eg, intravitreal corticosteroid injection, anti-angiogenic drugs, or device implantation) in the study eye.\n* Previous treatment or participation in a clinical trial involving anti-angiogenic drugs (Avastin(R), anecortave acetate, protein kinase C inhibitors, etc), in the non-study eye within 3 months of Day 0 (first day of treatment). The patient may not have received Lucentis(R) or Macugen(R) in the non-study eye within 7 days of Day 0.\n* Treatment with Visudyne(R) in the non-study eye \\< 7 days preceding Day 0.\n* Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either \\> 50% of the total area of the lesion or \\> 1 disc area (2.54 mm\\^2) in size.\n* Subfoveal fibrosis or atrophy in the study eye.\n* CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia.\n* Retinal pigment epithelial tear involving the macula in the study eye.\n* Any concurrent intraocular condition in the study eye (eg, cataract or diabetic retinopathy) that, in the opinion of the investigator, could either: Require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition; or if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity (BCVA) over the 24-month study period.\n* Uncontrolled blood pressure.\n* Atrial fibrillation not managed by patient's primary care physician or cardiologist within 3 months of screening visit.\n* History of stroke within the last 3 months of screening visit.\n* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications.\n* Current treatment for active systemic infection.\n* Active malignancy.\n* History of allergy to fluorescein, not amenable to treatment.\n* Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)."}, 'identificationModule': {'nctId': 'NCT00891735', 'acronym': 'HARBOR', 'briefTitle': 'A Study of Ranibizumab Administered Monthly or on an As-needed Basis in Patients With Subfoveal Neovascular Age-related Macular Degeneration (HARBOR)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase III, Double-masked, Multicenter, Randomized, Active Treatment-controlled Study of the Efficacy and Safety of 0.5 mg and 2.0 mg Ranibizumab Administered Monthly or on an As-needed Basis (PRN) in Patients With Subfoveal Neovascular Age-related Macular Degeneration', 'orgStudyIdInfo': {'id': 'FVF4579g'}, 'secondaryIdInfos': [{'id': 'GX01511', 'type': 'OTHER', 'domain': 'Hoffmann-La Roche'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ranibizumab 0.5 mg monthly', 'description': 'Patients received ranibizumab 0.5 mg monthly administered intravitreally for 24 months.', 'interventionNames': ['Drug: Ranibizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Ranibizumab 2.0 mg monthly', 'description': 'Patients received ranibizumab 2.0 mg monthly administered intravitreally for 24 months.', 'interventionNames': ['Drug: Ranibizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Ranibizumab 0.5 mg as-needed (pro re nata [PRN])', 'description': "Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 21 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.", 'interventionNames': ['Drug: Ranibizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Ranibizumab 2.0 mg as-needed (pro re nata [PRN])', 'description': "Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 21 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.", 'interventionNames': ['Drug: Ranibizumab']}], 'interventions': [{'name': 'Ranibizumab', 'type': 'DRUG', 'otherNames': ['Lucentis'], 'description': 'Sterile solution for intravitreal injection.', 'armGroupLabels': ['Ranibizumab 0.5 mg as-needed (pro re nata [PRN])', 'Ranibizumab 0.5 mg monthly', 'Ranibizumab 2.0 mg as-needed (pro re nata [PRN])', 'Ranibizumab 2.0 mg monthly']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91007', 'city': 'Arcadia', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.13973, 'lon': -118.03534}}, {'zip': '90211', 'city': 'Beverly Hills', 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