Ignite Creation Date:
2025-12-24 @ 1:47 PM
Ignite Modification Date:
2026-01-02 @ 1:00 AM
Study NCT ID:
NCT00379795
Status:
COMPLETED
Last Update Posted:
2017-05-11
First Post:
2006-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects With Choroidal Neovascularization Secondary to AMD or Macular Edema Secondary to RVO
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020256', 'term': 'Choroidal Neovascularization'}, {'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal 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': {'email': 'ctg-post-d@gene.com', 'title': 'Genentech', 'organization': 'Genentech'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The summary includes adverse events that occurred from enrollment in this extension study through 36 months (+/- 7 days).', 'description': 'Safety Population includes all participants who received at least one dose of study drug in one of the initial studies or this extension study. As per the protocol participants who did not receive study drug were excluded from the analyses.\n\nOnly adverse events that occurred during this extension study are reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Ranibizumab Treated Initial Mono', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.', 'otherNumAtRisk': 526, 'otherNumAffected': 491, 'seriousNumAtRisk': 526, 'seriousNumAffected': 213}, {'id': 'EG001', 'title': 'Ranibizumab Treated Initial + PDT', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.', 'otherNumAtRisk': 74, 'otherNumAffected': 70, 'seriousNumAtRisk': 74, 'seriousNumAffected': 26}, {'id': 'EG002', 'title': 'Ranibizumab Treated Sham XO', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g or this extension study.', 'otherNumAtRisk': 116, 'otherNumAffected': 110, 'seriousNumAtRisk': 116, 'seriousNumAffected': 43}, {'id': 'EG003', 'title': 'Ranibizumab Treated PDT XO', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.', 'otherNumAtRisk': 74, 'otherNumAffected': 71, 'seriousNumAtRisk': 74, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'MACULAR DEGENERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 236}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 53}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 22}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'RETINAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 197}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 47}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 31}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'CONJUNCTIVAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 124}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 17}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'CHOROIDAL NEOVASCULARISATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'MACULAR OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'CATARACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'EYE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'MYODESOPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'VISUAL ACUITY REDUCED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'DETACHMENT OF RETINAL PIGMENT EPITHELIUM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'MACULOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'VISION BLURRED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'EYE IRRITATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'POSTERIOR CAPSULE OPACIFICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'FOREIGN BODY SENSATION IN EYES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'BLEPHARITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'EYE PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'RETINAL DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'RETINAL DEGENERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'DRY EYE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'PHOTOPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'EAR INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'CONTUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'INTRAOCULAR PRESSURE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'BASAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}], 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{'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'ACUTE CORONARY SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'ANGINA UNSTABLE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'ARRHYTHMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'CARDIAC ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Ocular Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab Treated Initial Mono', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.'}, {'id': 'OG001', 'title': 'Ranibizumab Treated Initial + PDT', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.'}, {'id': 'OG002', 'title': 'Ranibizumab Treated Sham XO', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.'}, {'id': 'OG003', 'title': 'Ranibizumab Treated PDT XO', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.'}], 'classes': [{'title': 'Any adverse event in study eye', 'categories': [{'measurements': [{'value': '418', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}]}, {'title': 'Serious adverse events in study eye', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Adverse events led to discontinuation, study eye', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Endophthalmitis in study eye', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Intraocular inflammation in study eye, total', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Serious Intraocular inflammation in study eye', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any adverse event in fellow eye', 'categories': [{'measurements': [{'value': '304', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}]}, {'title': 'Serious adverse events in fellow eye', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Adverse events led to discontinuation, fellow eye', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Endophthalmitis in fellow eye', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Intraocular inflammation in fellow eye, total', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Serious intraocular inflammation in fellow eye', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '36 months', 'description': 'Number of participants with ocular adverse events in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation, endophthalmitis and intraocular inflammation that occurred in the study eye (the eye that received all study drug injections) and the fellow eye (other eye).\n\nOnly adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants treated with Ranibizumab in this extension study or in one of the previous studies.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Non-ocular Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab Treated Initial Mono', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.'}, {'id': 'OG001', 'title': 'Ranibizumab Treated Initial + PDT', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.'}, {'id': 'OG002', 'title': 'Ranibizumab Treated Sham XO', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.'}, {'id': 'OG003', 'title': 'Ranibizumab Treated PDT XO', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.'}], 'classes': [{'title': 'Any non ocular adverse event', 'categories': [{'measurements': [{'value': '427', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}]}, {'title': 'Serious non ocular adverse event', 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}]}, {'title': 'Non ocular adverse events led to discontinuation', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '36 months', 'description': 'Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death.\n\nOnly adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.\n\nAdditional information about adverse events can be found in the adverse events section.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants treated with Ranibizumab in this extension study or in one of the previous studies.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '600', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '853', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab Initial Group', 'description': 'In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were initially enrolled and received treatment with Ranibizumab in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823).'}, {'id': 'OG001', 'title': 'Ranibizumab Crossover Group', 'description': 'In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were enrolled but did not initially receive Ranibizumab in Study FVF2428g (NCT00056823), Study FVF2587g (NCT00061594) or Study FVF2598g (NCT00056836) and then crossed over to receive Ranibizumab either in that initial study or this extension study.'}, {'id': 'OG002', 'title': 'Ranibizumab Untreated Group', 'description': 'In this extension study participants did not receive Ranibizumab. Participants in this group were enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823) but did not receive treatment with Ranibizumab in that study or this extension study.'}, {'id': 'OG003', 'title': 'Total', 'description': 'All enrolled subjects'}], 'classes': [{'title': 'Change from Baseline at Month 3 (n=284, 84, 25)', 'categories': [{'measurements': [{'value': '-2.9', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '11.0', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '6.6', 'groupId': 'OG002'}, {'value': '-2.7', 'spread': '9.3', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Month 6 (n=519, 149, 46)', 'categories': [{'measurements': [{'value': '-3.4', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '10.5', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '7.0', 'groupId': 'OG002'}, {'value': '-2.8', 'spread': '9.1', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Month 9 (n=490, 149, 38)', 'categories': [{'measurements': [{'value': '-4.4', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '11.3', 'groupId': 'OG001'}, {'value': '-2.2', 'spread': '7.5', 'groupId': 'OG002'}, {'value': '-3.7', 'spread': '10.8', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Month 12 (n=481, 142, 38)', 'categories': [{'measurements': [{'value': '-5.2', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '11.5', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '8.0', 'groupId': 'OG002'}, {'value': '-4.5', 'spread': '11.1', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Month 15 (n=447, 138, 31)', 'categories': [{'measurements': [{'value': '-5.6', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '12.4', 'groupId': 'OG001'}, {'value': '-3.0', 'spread': '8.9', 'groupId': 'OG002'}, {'value': '-4.7', 'spread': '11.2', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Month 18 (n=420, 135, 28)', 'categories': [{'measurements': [{'value': '-6.4', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '12.5', 'groupId': 'OG001'}, {'value': '-4.4', 'spread': '9.5', 'groupId': 'OG002'}, {'value': '-5.3', 'spread': '12.1', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Month 21 (n=405, 129, 28)', 'categories': [{'measurements': [{'value': '-7.9', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '13.3', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '10.8', 'groupId': 'OG002'}, {'value': '-6.3', 'spread': '13.2', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Month 24 (n=388, 127, 27)', 'categories': [{'measurements': [{'value': '-8.1', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '13.5', 'groupId': 'OG001'}, {'value': '-2.9', 'spread': '8.5', 'groupId': 'OG002'}, {'value': '-6.4', 'spread': '13.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Extension study baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24', 'description': 'Change from baseline in Best corrected visual acuity (BCVA) was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a starting test distance of 2 meters. An increase in the number of letters read indicates improvement in visual acuity.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by "n".'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '600', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '853', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab Initial Group', 'description': 'In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were initially enrolled and received treatment with Ranibizumab in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823).'}, {'id': 'OG001', 'title': 'Ranibizumab Crossover Group', 'description': 'In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were enrolled but did not initially receive Ranibizumab in Study FVF2428g (NCT00056823), Study FVF2587g (NCT00061594) or Study FVF2598g (NCT00056836) and then crossed over to receive Ranibizumab either in the initial study or this extension study.'}, {'id': 'OG002', 'title': 'Ranibizumab Untreated Group', 'description': 'In this extension study participants did not receive Ranibizumab. Participants in this group were enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823) but did not receive treatment with Ranibizumab in that study or this extension study.'}, {'id': 'OG003', 'title': 'Total', 'description': 'All enrolled subjects'}], 'classes': [{'title': 'Change from Baseline at Month 12 (n=446,133,35)', 'categories': [{'measurements': [{'value': '-5.4', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '11.8', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '7.2', 'groupId': 'OG002'}, {'value': '-4.4', 'spread': '11.7', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline at Month 24 (n=352,122,25)', 'categories': [{'measurements': [{'value': '-7.5', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '13.0', 'groupId': 'OG001'}, {'value': '-3.1', 'spread': '8.2', 'groupId': 'OG002'}, {'value': '-5.7', 'spread': '12.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Extension study baseline, Months 12 and 24', 'description': 'Change from baseline in Best corrected visual acuity (BCVA) was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a starting test distance of 4 meters. An increase in the number of letters read indicates improvement in visual acuity.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled participants. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by "n".'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab Treated Initial Mono', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.'}, {'id': 'OG001', 'title': 'Ranibizumab Treated Initial + PDT', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.'}, {'id': 'OG002', 'title': 'Ranibizumab Treated Sham XO', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.'}, {'id': 'OG003', 'title': 'Ranibizumab Treated PDT XO', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.'}], 'classes': [{'title': 'Month 12 (n=393,55,72,50)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Month 24 (n=316,45,78,42)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12 and 24', 'description': 'Serum samples for the evaluation of antibodies to Ranibizumab were collected at Month 12 and Month 24 and were sent to a reference laboratory for analysis. If an injection of Ranibizumab was required at the visit, the samples were collected prior to the injection.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population included all enrolled participants treated with Ranibizumab in the extension study or in one of the initial studies. The number of participants for whom data was available at Month 12 and Month 24 are represented by "n"'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RanibizumabTreated Initial Mono', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group received ranibizumab monotherapy (Mono) in previous studies, that is, ranibizumab alone in study FVF2598g or ranibizumab in combination with sham photodynamic therapy (PDT) in study FVF2587g.'}, {'id': 'FG001', 'title': 'RanibizumabTreated Initial + PDT', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab in combination with photodynamic therapy in Study FVF2428g'}, {'id': 'FG002', 'title': 'RanibizumabTreated Sham XO', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab intravitreal injections in study FVF2598g or this extension study.'}, {'id': 'FG003', 'title': 'Ranibizumab Treated PDT XO', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in study FVF2428g or study FVF2587g before crossing over to receive ranibizumab intravitreal injections in study FVF2428g, study FVF2587g or this study.'}, {'id': 'FG004', 'title': 'Ranibizumab Untreated Group', 'description': 'In this extension study participants did not receive Ranibizumab. Participants in this group were enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) FVF2598g (NCT0056823) but did not receive Ranibizumab intravitreal injections in that study or in this extension study (FVF3426g).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '526'}, {'groupId': 'FG001', 'numSubjects': '74'}, {'groupId': 'FG002', 'numSubjects': '116'}, {'groupId': 'FG003', 'numSubjects': '74'}, {'groupId': 'FG004', 'numSubjects': '63'}]}, {'type': 'Received Ranibizumab in Extension Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '377'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '113'}, {'groupId': 'FG003', 'numSubjects': '55'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '476'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '93'}, {'groupId': 'FG003', 'numSubjects': '68'}, {'groupId': 'FG004', 'numSubjects': '49'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '7'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '14'}]}, {'type': 'Subject non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Verteporfin photodynamic therapy in eye', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Subjects condition mandated intervention', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '7'}]}, {'type': "Sponsor's decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '257'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '47'}, {'groupId': 'FG004', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'This is an open label multicenter extension study for participants who have completed one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823). Cohort 1 includes patients with Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD).', 'preAssignmentDetails': 'Participants were classified according to ranibizumab exposure in the previous study and in the extension study. 63 participants (Untreated Group) did not receive study drug in this extension study or in the previous studies and are not included in the safety analyses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '526', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}, {'value': '853', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'RanibizumabTreated Initial Mono', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group received ranibizumab 0.5 mg monotherapy, that is, ranibizumab alone in study FVF2598g or ranibizumab in combination with sham photodynamic therapy (PDT) in study FVF2587g.'}, {'id': 'BG001', 'title': 'RanibizumabTreated Initial + PDT', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injections in combination with photodynamic therapy in Study FVF2428g.'}, {'id': 'BG002', 'title': 'RanibizumabTreated Sham XO', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5mg intravitreal injections in previous study FVF2598g or in this extension study.'}, {'id': 'BG003', 'title': 'Ranibizumab Treated PDT XO', 'description': 'In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in study FVF2428g or study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injections in previous studies FVF2428g, study FVF2587g or this extension study.'}, {'id': 'BG004', 'title': 'Ranibizumab Untreated Group', 'description': 'In this extension study participants did not receive Ranibizumab. Participants in this group were previously enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594), FVF2598g (NCT0056823) but did not receive treatment with Ranibizumab in that study or in this extension study (FVF3426g).'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '50 to < 65', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '51', 'groupId': 'BG005'}]}]}, {'title': '65 to < 75', 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '194', 'groupId': 'BG005'}]}]}, {'title': '75 to < 85', 'categories': [{'measurements': [{'value': '277', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}, {'value': '444', 'groupId': 'BG005'}]}]}, {'title': '>= 85', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '164', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '304', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '499', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '222', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}, {'value': '354', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 853}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-05', 'studyFirstSubmitDate': '2006-09-21', 'resultsFirstSubmitDate': '2011-04-01', 'studyFirstSubmitQcDate': '2006-09-21', 'lastUpdatePostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-12-05', 'studyFirstPostDateStruct': {'date': '2006-09-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Ocular Adverse Events', 'timeFrame': '36 months', 'description': 'Number of participants with ocular adverse events in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation, endophthalmitis and intraocular inflammation that occurred in the study eye (the eye that received all study drug injections) and the fellow eye (other eye).\n\nOnly adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.'}, {'measure': 'Number of Participants With Non-ocular Adverse Events', 'timeFrame': '36 months', 'description': 'Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death.\n\nOnly adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.\n\nAdditional information about adverse events can be found in the adverse events section.'}, {'measure': 'Number of Participants With Positive Serum Antibodies to Ranibizumab at Month 12 and Month 24', 'timeFrame': 'Month 12 and 24', 'description': 'Serum samples for the evaluation of antibodies to Ranibizumab were collected at Month 12 and Month 24 and were sent to a reference laboratory for analysis. If an injection of Ranibizumab was required at the visit, the samples were collected prior to the injection.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Best Corrected Visual Acuity (BCVA) at a Starting Test Distance of 2 Meters', 'timeFrame': 'Extension study baseline, Months 3, 6, 9, 12, 15, 18, 21 and 24', 'description': 'Change from baseline in Best corrected visual acuity (BCVA) was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a starting test distance of 2 meters. An increase in the number of letters read indicates improvement in visual acuity.'}, {'measure': 'Change From Baseline in Best Corrected Visual Acuity at a Starting Test Distance of 4 Meters', 'timeFrame': 'Extension study baseline, Months 12 and 24', 'description': 'Change from baseline in Best corrected visual acuity (BCVA) was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a starting test distance of 4 meters. An increase in the number of letters read indicates improvement in visual acuity.'}]}, 'conditionsModule': {'keywords': ['CNV', 'Lucentis', 'AMD', 'Age-related macular degeneration', 'RVO'], 'conditions': ['Choroidal Neovascularization, Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'This was an open-label, multicenter, extension study of intravitreally administered ranibizumab in two cohorts. The first cohort (reported here) enrolled patients with primary or recurrent Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) who completed the treatment phase of a Genentech sponsored study (FVF2598g (NCT00056836), FVF2587g (NCT00061594), or FVF2428g (NCT00056823)). The second cohort enrolled patients with macular edema secondary to Retinal Vein Occlusion (RVO) who completed the 6-month treatment and 6-month observation phases (12 months total) of a Genentech sponsored study (FVF4165g (NCT00486018) or FVF4166g (NCT00485836)). The results of the second cohort are reported separately (NCT01442064). The first cohort of this study enrolled two subsets of patients: ranibizumab experienced and ranibizumab-naive. Patients were enrolled within 14 days of completion of the 24 month treatment phase of the previous study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent form.\n* Completion of the treatment phase (through Month 24) of a Genentech-sponsored ranibizumab study for AMD (FVF2598g, FVF2587g, or FVF2428g) (Cohort 1)\n* Expectation by the investigator that the subject may potentially benefit from intravitreal anti-vascular endothelial growth factor (VEGF) treatment\n\nExclusion Criteria:\n\n* Previous subfoveal focal laser photocoagulation in the study eye\n* Previous pegaptanib sodium injection in the study eye\n* Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0 of this extension study\n* History of submacular surgery or other surgical intervention for AMD in the study eye\n* History of glaucoma filtering surgery in the study eye\n* History of corneal transplant in the study eye\n* Concurrent use of systemic anti-EGF agents\n* Use of AMD treatments not approved by the FDA\n* Use of intravitreal Avastin(R) (bevacizumab) in the study eye and/or fellow eye\n* CNV in either eye due to other causes than AMD, such as ocular histoplasmosis, trauma, or pathologic myopia for Cohort 1\n* History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye\n* History of idiopathic or autoimmune-associated uveitis in either eye\n* Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 30 mmHg despite treatment with antiglaucoma medication)\n* Pregnancy or lactation\n* Premenopausal women not using adequate contraception\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 render the subject at high risk for treatment complications\n* Current treatment for active systemic infection\n* Inability to comply with study or follow-up procedures'}, 'identificationModule': {'nctId': 'NCT00379795', 'briefTitle': 'An Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects With Choroidal Neovascularization Secondary to AMD or Macular Edema Secondary to RVO', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD) or Macular Edema Secondary to Retinal Vein Occlusion (RVO) Who Have Completed a Genentech-Sponsored Ranibizumab Study', 'orgStudyIdInfo': {'id': 'FVF3426g (Cohort 1)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ranibizumad 0.5 mg', 'description': 'Ranibizumab 0.5 mg intravitreal injection 0.5 mg in the study eye on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment.', 'interventionNames': ['Drug: Ranibizumab 0.5 mg']}], 'interventions': [{'name': 'Ranibizumab 0.5 mg', 'type': 'DRUG', 'description': 'Ranibizumab intravitreal injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year)', 'armGroupLabels': ['Ranibizumad 0.5 mg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lisa Tuomi, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}