Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-28 @ 5:03 PM
Study NCT ID:
NCT00687804
Status:
COMPLETED
Last Update Posted:
2013-04-01
First Post:
2008-05-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A 12 Month Core Study to Assess the Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema and a 24 Month Open-label Extension Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}, {'id': 'D007834', 'term': 'Lasers'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862 778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Safety Population included all randomized treated participants. Participants are grouped according to the treatment actually received in the Core Study.', 'eventGroups': [{'id': 'EG000', 'title': 'Ranibizumab 0.5 mg', 'description': "Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy.", 'otherNumAtRisk': 115, 'otherNumAffected': 79, 'seriousNumAtRisk': 115, 'seriousNumAffected': 41}, {'id': 'EG001', 'title': 'Ranibizumab 0.5 mg + Laser', 'description': "Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy", 'otherNumAtRisk': 120, 'otherNumAffected': 83, 'seriousNumAtRisk': 120, 'seriousNumAffected': 43}, {'id': 'EG002', 'title': 'Laser With Ranibizumab in Extension', 'description': "Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy.", 'otherNumAtRisk': 59, 'otherNumAffected': 50, 'seriousNumAtRisk': 59, 'seriousNumAffected': 28}, {'id': 'EG003', 'title': 'Laser Without Ranibizumab in Extension', 'description': "Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy.", 'otherNumAtRisk': 51, 'otherNumAffected': 31, 'seriousNumAtRisk': 51, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blepharitis (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cataract (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cataract (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Conjunctival haemorrhage (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Conjunctival hyperaemia (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Conjunctivitis (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetic retinal oedema (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetic retinal oedema (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetic retinopathy (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetic retinopathy (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dry eye (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dry eye (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye discharge (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye haemorrhage (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye haemorrhage (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye irritation (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye pain (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye pruritus (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Foreign body sensation in eyes (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lacrimation increased (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Macular fibrosis (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Punctate keratitis (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retinal aneurysm (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retinal exudates (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retinal exudates (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retinal haemorrhage (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vision blurred (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Visual acuity reduced (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Visual acuity reduced (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vitreous haemorrhage (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 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0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasal septum deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute febrile neutrophilic dermatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skin hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arterial thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 115, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Core Study: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg', 'description': 'Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.'}, {'id': 'OG001', 'title': 'Ranibizumab 0.5 mg + Laser', 'description': 'Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.'}, {'id': 'OG002', 'title': 'Laser', 'description': 'Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '64.7', 'spread': '10.07', 'groupId': 'OG000'}, {'value': '63.4', 'spread': '9.99', 'groupId': 'OG001'}, {'value': '62.6', 'spread': '11.01', 'groupId': 'OG002'}]}]}, {'title': 'Average Month 1 to month 12', 'categories': [{'measurements': [{'value': '70.8', 'spread': '10.53', 'groupId': 'OG000'}, {'value': '69.2', 'spread': '11.44', 'groupId': 'OG001'}, {'value': '63.4', 'spread': '12.26', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '6.1', 'spread': '6.43', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '7.92', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '8.56', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline through the end of study (Month 12)', 'description': 'Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set consists of all patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent to treat principle, patients were analyzed according to the treatment assigned. Last Observation Carried Forward (LOCF) imputation was utilized.'}, {'type': 'SECONDARY', 'title': 'Core Study: Categorized Change in Visual Acuity (Letters) of the Study Eye From Baseline at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg', 'description': 'Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.'}, {'id': 'OG001', 'title': 'Ranibizumab 0.5 mg + Laser', 'description': 'Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.'}, {'id': 'OG002', 'title': 'Laser', 'description': 'Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.'}], 'classes': [{'title': 'Gain of ≥ 10 letters', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Loss of ≥ 10 letters', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Gain of ≥ 15 letters', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Loss of ≥ 15 letters', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 12', 'description': 'Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set consists of all patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent to treat principle, patients were analyzed according to the treatment assigned. Last Observation Carried Forward (LOCF) imputation was utilized.'}, {'type': 'SECONDARY', 'title': 'Core Study: Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg', 'description': 'Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.'}, {'id': 'OG001', 'title': 'Ranibizumab 0.5 mg + Laser', 'description': 'Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.'}, {'id': 'OG002', 'title': 'Laser', 'description': 'Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.'}], 'classes': [{'title': 'Month 1', 'categories': [{'measurements': [{'value': '2.9', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.56', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.64', 'groupId': 'OG002'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '0.56', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.84', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '5.9', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '0.65', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.92', 'groupId': 'OG002'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '5.3', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '0.69', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.92', 'groupId': 'OG002'}]}]}, {'title': 'Month 5', 'categories': [{'measurements': [{'value': '5.9', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '0.88', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '6.7', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '0.78', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '0.94', 'groupId': 'OG002'}]}]}, {'title': 'Month 7', 'categories': [{'measurements': [{'value': '7.0', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '0.84', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '0.98', 'groupId': 'OG002'}]}]}, {'title': 'Month 8', 'categories': [{'measurements': [{'value': '7.1', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '1.06', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '0.96', 'groupId': 'OG002'}]}]}, {'title': 'Month 9', 'categories': [{'measurements': [{'value': '6.8', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '1.05', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '0.90', 'groupId': 'OG002'}]}]}, {'title': 'Month 10', 'categories': [{'measurements': [{'value': '7.3', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '1.04', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '1.00', 'groupId': 'OG002'}]}]}, {'title': 'Month 11', 'categories': [{'measurements': [{'value': '6.9', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '1.10', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '0.95', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '6.8', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '1.08', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.09', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 12', 'description': 'Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, utilizing last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Core Study: Mean Change From Baseline at Month 12 in Central Retinal Thickness of the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg', 'description': 'Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.'}, {'id': 'OG001', 'title': 'Ranibizumab 0.5 mg + Laser', 'description': 'Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.'}, {'id': 'OG002', 'title': 'Laser', 'description': 'Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '427.1', 'spread': '118.42', 'groupId': 'OG000'}, {'value': '416.4', 'spread': '119.91', 'groupId': 'OG001'}, {'value': '412.4', 'spread': '124.53', 'groupId': 'OG002'}]}]}, {'title': 'Value at Month 12', 'categories': [{'measurements': [{'value': '308.4', 'spread': '112.26', 'groupId': 'OG000'}, {'value': '288.2', 'spread': '90.11', 'groupId': 'OG001'}, {'value': '351.1', 'spread': '139.91', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '-118.7', 'spread': '115.07', 'groupId': 'OG000'}, {'value': '-128.3', 'spread': '114.34', 'groupId': 'OG001'}, {'value': '-61.3', 'spread': '132.29', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 12', 'description': 'Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation.', 'unitOfMeasure': 'Micrometers', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed is the Full Analysis Set, including patients with a value at both baseline and the Month 12 visit. Last Observation Carried Forward imputation was utilized.'}, {'type': 'SECONDARY', 'title': 'Core Study: Mean Change From Baseline in Patient-reported Visual Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg', 'description': 'Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.'}, {'id': 'OG001', 'title': 'Ranibizumab 0.5 mg + Laser', 'description': 'Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.'}, {'id': 'OG002', 'title': 'Laser', 'description': 'Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '72.8', 'spread': '16.91', 'groupId': 'OG000'}, {'value': '74.1', 'spread': '18.06', 'groupId': 'OG001'}, {'value': '73.5', 'spread': '18.18', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '77.8', 'spread': '19.19', 'groupId': 'OG000'}, {'value': '79.5', 'spread': '17.29', 'groupId': 'OG001'}, {'value': '74.1', 'spread': '18.80', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '5.0', 'spread': '12.97', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '11.14', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '12.56', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 12', 'description': "The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure a patient's subjective assessment of vision-related quality of life. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed is the Full Analysis Set, including the number of patients with a value at both baseline and the Month 12 visit. Last Observation Carried Forward imputation was utilized.'}, {'type': 'PRIMARY', 'title': 'Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 24 Month Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg', 'description': "Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}, {'id': 'OG001', 'title': 'Ranibizumab 0.5 mg + Laser', 'description': "Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}, {'id': 'OG002', 'title': 'Laser With Ranibizumab in Extension', 'description': "Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}, {'id': 'OG003', 'title': 'Laser Without Ranibizumab in Extension', 'description': "Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '56.6', 'groupId': 'OG000'}, {'value': '56.6', 'groupId': 'OG001'}, {'value': '52.5', 'groupId': 'OG002'}, {'value': '40.0', 'groupId': 'OG003'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '1.7', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months]', 'description': 'Participants with ocular (occurring in the eye) serious adverse events (SAEs) and non-serious AEs in the study eye. The study eye is the eye that received the treatment. AEs are the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.\n\nAdditional information about adverse events can be found in the Adverse Event section.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.'}, {'type': 'SECONDARY', 'title': 'Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 36 Months of the Core and Extension Studies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg', 'description': "Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}, {'id': 'OG001', 'title': 'Ranibizumab 0.5 mg + Laser', 'description': "Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}, {'id': 'OG002', 'title': 'Laser With Ranibizumab in Extension', 'description': "Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}, {'id': 'OG003', 'title': 'Laser Without Ranibizumab in Extension', 'description': "Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '66.3', 'groupId': 'OG000'}, {'value': '67.5', 'groupId': 'OG001'}, {'value': '64.4', 'groupId': 'OG002'}, {'value': '46.7', 'groupId': 'OG003'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}, {'value': '5.1', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Core baseline (Day 1 of the core study) to Month 36 (end of extension study) [36 months]', 'description': 'Participants with ocular (occurring in the eye) serious adverse events (SAEs) and non-serious AEs in the study eye. The study eye is the eye that received the treatment. AEs are the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.\n\nAdditional information about adverse events can be found in the Adverse Event section.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.'}, {'type': 'SECONDARY', 'title': 'Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 36 Months of the Core and Extension Studies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg', 'description': "Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}, {'id': 'OG001', 'title': 'Ranibizumab 0.5 mg + Laser', 'description': "Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}, {'id': 'OG002', 'title': 'Laser With Ranibizumab in Extension', 'description': "Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}, {'id': 'OG003', 'title': 'Laser Without Ranibizumab in Extension', 'description': "Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '83.1', 'groupId': 'OG000'}, {'value': '81.9', 'groupId': 'OG001'}, {'value': '84.7', 'groupId': 'OG002'}, {'value': '73.3', 'groupId': 'OG003'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '36.1', 'groupId': 'OG000'}, {'value': '37.3', 'groupId': 'OG001'}, {'value': '42.4', 'groupId': 'OG002'}, {'value': '13.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Core baseline (Day 1 of the core study) to Month 36 (end of extension study) [36 Months]', 'description': 'Participants with non-ocular (not occurring in the eye) serious adverse events (SAEs) and non-serious AEs. AEs are the appearance or worsening of of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.\n\nAdditional information about Adverse Events can be found in the Adverse Event section.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.'}, {'type': 'PRIMARY', 'title': 'Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 24 Month Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg', 'description': "Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}, {'id': 'OG001', 'title': 'Ranibizumab 0.5 mg + Laser', 'description': "Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}, {'id': 'OG002', 'title': 'Laser With Ranibizumab in Extension', 'description': "Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}, {'id': 'OG003', 'title': 'Laser Without Ranibizumab in Extension', 'description': "Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}], 'classes': [{'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '73.5', 'groupId': 'OG000'}, {'value': '73.5', 'groupId': 'OG001'}, {'value': '71.2', 'groupId': 'OG002'}, {'value': '73.3', 'groupId': 'OG003'}]}]}, {'title': 'Serious Adverse Events', 'categories': [{'measurements': [{'value': '27.7', 'groupId': 'OG000'}, {'value': '30.1', 'groupId': 'OG001'}, {'value': '37.3', 'groupId': 'OG002'}, {'value': '13.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months]', 'description': 'Participants with non-ocular (not occurring in the eye) serious adverse events (SAEs) and non-serious AEs. AEs are the appearance or worsening of of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.\n\nAdditional information about adverse events can be found in the Adverse Event section.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.'}, {'type': 'SECONDARY', 'title': 'Extension Study: Mean Change From Extension Study Baseline in Best Corrected Visual Acuity (BCVA) at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg', 'description': "Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}, {'id': 'OG001', 'title': 'Ranibizumab 0.5 mg + Laser', 'description': "Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}, {'id': 'OG002', 'title': 'Active Laser', 'description': "Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '9.10', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '9.19', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '6.88', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Extension baseline (Month12 -end of core study), Month 36 (end of extension study)', 'description': 'Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. An increase in the number of letters read correctly indicates improvement.', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Safety Population that included all participants who entered the extension and who had at least one safety assessment in the extension study with data available for analyses. Participants were grouped according to the treatment assigned in the Core study.'}, {'type': 'SECONDARY', 'title': 'Extension Study: Mean Change From Core Study Baseline in Best Corrected Visual Acuity (BCVA) at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab 0.5 mg', 'description': "Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}, {'id': 'OG001', 'title': 'Ranibizumab 0.5 mg + Laser', 'description': "Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}, {'id': 'OG002', 'title': 'Active Laser', 'description': "Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'spread': '10.09', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '9.59', 'groupId': 'OG001'}, {'value': '6.0', 'spread': '9.35', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Core baseline (Day 1 of the core study), Month 36 (end of extension study)', 'description': 'Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. An increase in the number of letters read correctly indicates improvement.', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who entered the extension and who had at least one safety assessment in the extension study. Participants were grouped according to the treatment assigned in the Core study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ranibizumab 0.5 mg', 'description': "Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}, {'id': 'FG001', 'title': 'Ranibizumab 0.5 mg + Laser', 'description': "Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}, {'id': 'FG002', 'title': 'Laser', 'description': "Active laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy."}], 'periods': [{'title': 'Core Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}, {'groupId': 'FG001', 'numSubjects': '118'}, {'groupId': 'FG002', 'numSubjects': '111'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '103'}, {'groupId': 'FG002', 'numSubjects': '98'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Abnormal laboratory value(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Open-Label Extension Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '83'}, {'groupId': 'FG002', 'numSubjects': '74'}]}, {'type': 'Did Not Receive Ranibizumab in Extension', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Subject withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'Participants who completed the 12 month randomized core study CRFB002D2301 were eligible to participate in the 24 month open-label extension study CRFB002D2301E1. The reporting groups for the participants in the extension study are according to their assigned treatment groups in the core study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Ranibizumab 0.5 mg', 'description': 'Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.'}, {'id': 'BG001', 'title': 'Ranibizumab 0.5 mg + Laser', 'description': 'Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.'}, {'id': 'BG002', 'title': 'Laser', 'description': 'Laser photocoagulation treatment was administered on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.9', 'spread': '9.29', 'groupId': 'BG000'}, {'value': '64.0', 'spread': '8.15', 'groupId': 'BG001'}, {'value': '63.5', 'spread': '8.81', 'groupId': 'BG002'}, {'value': '63.5', 'spread': '8.75', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 55 years', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}]}, {'title': '55 - <65 years', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}]}, {'title': '65 - <75 years', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}]}]}, {'title': '>=75 years', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '201', 'groupId': 'BG003'}]}]}], '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': 345}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-26', 'studyFirstSubmitDate': '2008-05-27', 'resultsFirstSubmitDate': '2011-01-19', 'studyFirstSubmitQcDate': '2008-05-30', 'lastUpdatePostDateStruct': {'date': '2013-04-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-23', 'studyFirstPostDateStruct': {'date': '2008-06-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Core Study: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12', 'timeFrame': 'Baseline through the end of study (Month 12)', 'description': 'Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.'}, {'measure': 'Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 24 Month Extension Study', 'timeFrame': 'Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months]', 'description': 'Participants with ocular (occurring in the eye) serious adverse events (SAEs) and non-serious AEs in the study eye. The study eye is the eye that received the treatment. AEs are the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.\n\nAdditional information about adverse events can be found in the Adverse Event section.'}, {'measure': 'Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 24 Month Extension Study', 'timeFrame': 'Extension baseline (Month 12 -end of core study) to Month 36 (end of extension study) [24 Months]', 'description': 'Participants with non-ocular (not occurring in the eye) serious adverse events (SAEs) and non-serious AEs. AEs are the appearance or worsening of of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.\n\nAdditional information about adverse events can be found in the Adverse Event section.'}], 'secondaryOutcomes': [{'measure': 'Core Study: Categorized Change in Visual Acuity (Letters) of the Study Eye From Baseline at Month 12', 'timeFrame': 'Baseline to Month 12', 'description': 'Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.'}, {'measure': 'Core Study: Mean Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time', 'timeFrame': 'Baseline to Month 12', 'description': 'Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters.'}, {'measure': 'Core Study: Mean Change From Baseline at Month 12 in Central Retinal Thickness of the Study Eye', 'timeFrame': 'Baseline to Month 12', 'description': 'Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation.'}, {'measure': 'Core Study: Mean Change From Baseline in Patient-reported Visual Functioning', 'timeFrame': 'Baseline to Month 12', 'description': "The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure a patient's subjective assessment of vision-related quality of life. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function."}, {'measure': 'Extension Study: Percentage of Participants With Ocular Adverse Events (AEs) in the Study Eye in the 36 Months of the Core and Extension Studies', 'timeFrame': 'Core baseline (Day 1 of the core study) to Month 36 (end of extension study) [36 months]', 'description': 'Participants with ocular (occurring in the eye) serious adverse events (SAEs) and non-serious AEs in the study eye. The study eye is the eye that received the treatment. AEs are the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.\n\nAdditional information about adverse events can be found in the Adverse Event section.'}, {'measure': 'Extension Study: Percentage of Participants With Non-Ocular Adverse Events (AEs) in the 36 Months of the Core and Extension Studies', 'timeFrame': 'Core baseline (Day 1 of the core study) to Month 36 (end of extension study) [36 Months]', 'description': 'Participants with non-ocular (not occurring in the eye) serious adverse events (SAEs) and non-serious AEs. AEs are the appearance or worsening of of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. A serious adverse event is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.\n\nAdditional information about Adverse Events can be found in the Adverse Event section.'}, {'measure': 'Extension Study: Mean Change From Extension Study Baseline in Best Corrected Visual Acuity (BCVA) at Month 36', 'timeFrame': 'Extension baseline (Month12 -end of core study), Month 36 (end of extension study)', 'description': 'Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. An increase in the number of letters read correctly indicates improvement.'}, {'measure': 'Extension Study: Mean Change From Core Study Baseline in Best Corrected Visual Acuity (BCVA) at Month 36', 'timeFrame': 'Core baseline (Day 1 of the core study), Month 36 (end of extension study)', 'description': 'Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. An increase in the number of letters read correctly indicates improvement.'}]}, 'conditionsModule': {'keywords': ['DME', 'Diabetic', 'macula', 'edema', 'ranibizumab', 'RESTORE'], 'conditions': ['Diabetic Macular Edema']}, 'referencesModule': {'references': [{'pmid': '26584450', 'type': 'DERIVED', 'citation': 'Bressler NM, Varma R, Mitchell P, Suner IJ, Dolan C, Ward J, Ferreira A, Ehrlich JS, Turpcu A. Effect of Ranibizumab on the Decision to Drive and Vision Function Relevant to Driving in Patients With Diabetic Macular Edema: Report From RESTORE, RIDE, and RISE Trials. JAMA Ophthalmol. 2016 Feb;134(2):160-6. doi: 10.1001/jamaophthalmol.2015.4636.'}, {'pmid': '26327116', 'type': 'DERIVED', 'citation': 'Mitchell P, Massin P, Bressler S, Coon CD, Petrillo J, Ferreira A, Bressler NM. Three-year patient-reported visual function outcomes in diabetic macular edema managed with ranibizumab: the RESTORE extension study. Curr Med Res Opin. 2015 Nov;31(11):1967-75. doi: 10.1185/03007995.2015.1081880. Epub 2015 Oct 6.'}, {'pmid': '25148789', 'type': 'DERIVED', 'citation': 'Bressler NM, Varma R, Suner IJ, Dolan CM, Ward J, Ehrlich JS, Colman S, Turpcu A; RIDE and RISE Research Groups. Vision-related function after ranibizumab treatment for diabetic macular edema: results from RIDE and RISE. Ophthalmology. 2014 Dec;121(12):2461-72. doi: 10.1016/j.ophtha.2014.07.008. Epub 2014 Aug 20.'}, {'pmid': '24491642', 'type': 'DERIVED', 'citation': 'Schmidt-Erfurth U, Lang GE, Holz FG, Schlingemann RO, Lanzetta P, Massin P, Gerstner O, Bouazza AS, Shen H, Osborne A, Mitchell P; RESTORE Extension Study Group. Three-year outcomes of individualized ranibizumab treatment in patients with diabetic macular edema: the RESTORE extension study. Ophthalmology. 2014 May;121(5):1045-53. doi: 10.1016/j.ophtha.2013.11.041. Epub 2014 Feb 1.'}, {'pmid': '23974915', 'type': 'DERIVED', 'citation': 'Mitchell P, Bressler N, Tolley K, Gallagher M, Petrillo J, Ferreira A, Wood R, Bandello F; RESTORE Study Group. Patient-reported visual function outcomes improve after ranibizumab treatment in patients with vision impairment due to diabetic macular edema: randomized clinical trial. JAMA Ophthalmol. 2013 Oct;131(10):1339-47. doi: 10.1001/jamaophthalmol.2013.4592.'}, {'pmid': '21459215', 'type': 'DERIVED', 'citation': 'Mitchell P, Bandello F, Schmidt-Erfurth U, Lang GE, Massin P, Schlingemann RO, Sutter F, Simader C, Burian G, Gerstner O, Weichselberger A; RESTORE study group. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology. 2011 Apr;118(4):615-25. doi: 10.1016/j.ophtha.2011.01.031.'}]}, 'descriptionModule': {'briefSummary': 'CRFB002D2301: The core study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or mono-therapy in patients with visual impairment due to diabetic macular edema.\n\nCRFB002D2301E1: A 24 month open-label extension study for participants who completed the 12 month core study evaluated the long-term safety and efficacy of ranibizumab (0.5 mg) as symptomatic treatment for visual impairment due to diabetic macular edema.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Visual acuity impairment\n* Diabetic macular edema in at least one eye\n* Type 1 or type 2 diabetes mellitus\n* Medication for the diabetes treatment must be stable for the last 3 months\n\nExclusion Criteria:\n\n* Patients with uncontrolled systemic or ocular diseases\n* Laser photocoagulation in the study eye for the last 3 months\n* Any history of any intraocular surgery in the study eye within the past 3 months\n* Blood pressure \\> 160/100 mmHg\n\nExtension Inclusion Criteria:\n\n-Completion of the Core Study'}, 'identificationModule': {'nctId': 'NCT00687804', 'acronym': 'RESTORE', 'briefTitle': 'A 12 Month Core Study to Assess the Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema and a 24 Month Open-label Extension Study', 'nctIdAliases': ['NCT00906464'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-masked, Multicenter, Laser-controlled Phase III Study Assessing the Efficacy and Safety of Ranibizumab (Intravitreal Injections) as Adjunctive and Mono-therapy in Patients With Visual Impairment Due to Diabetic Macular Edema', 'orgStudyIdInfo': {'id': 'CRFB002D2301'}, 'secondaryIdInfos': [{'id': 'EUDRACT: 2007-004877-24'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ranibizumab 0.5 mg', 'description': "Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received sham laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy.", 'interventionNames': ['Drug: Ranibizumab', 'Procedure: Laser', 'Procedure: Sham laser']}, {'type': 'EXPERIMENTAL', 'label': 'Ranibizumab 0.5 mg + laser', 'description': "Ranibizumab 0.5 mg was administered monthly by intravitreal injection in the study eye for 3 months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nPatients also received active laser treatment on Day 1 and subsequently at intervals of at least 3 months, if deemed necessary by the evaluating physician.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy.", 'interventionNames': ['Drug: Ranibizumab', 'Procedure: Laser']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laser', 'description': "Laser photocoagulation treatment was administered on Day 1 and at intervals of at least 3 months, if deemed necessary by the physician. Patients also received monthly sham intravitreal injection in the study eye for 3 consecutive months. After the third injection, treatment was suspended if either one of the following criteria was met:\n\nImprovement in best corrected visual acuity (BCVA) could not be attributed to treatment at the last 2 visits, in the opinion of the investigator, or BCVA \\> 84 letters (approximate Snellen equivalent of 20/20) was observed at the last 2 last visits.\n\nActive/sham laser treatment was always administered before (sham) intravitreal injections. The minimum interval between the 2 treatments was 30 minutes.\n\nIn the extension study at the investigator's discretion, patients received open-label ranibizumab 0.5 mg intravitreal injections once a month until stable vision was reached (a maximum of 24 injections) and could receive laser therapy.", 'interventionNames': ['Drug: Ranibizumab', 'Procedure: Laser', 'Drug: Sham to ranibizumab']}], 'interventions': [{'name': 'Ranibizumab', 'type': 'DRUG', 'description': '0.5 mg ranibizumab administered by intravitreal injection.', 'armGroupLabels': ['Laser', 'Ranibizumab 0.5 mg', 'Ranibizumab 0.5 mg + laser']}, {'name': 'Laser', 'type': 'PROCEDURE', 'description': 'Laser photocoagulation treatment', 'armGroupLabels': ['Laser', 'Ranibizumab 0.5 mg', 'Ranibizumab 0.5 mg + laser']}, {'name': 'Sham laser', 'type': 'PROCEDURE', 'description': 'Sham to laser procedure.', 'armGroupLabels': ['Ranibizumab 0.5 mg']}, {'name': 'Sham to ranibizumab', 'type': 'DRUG', 'description': 'Sham to ranibizumab administered as an intravitreal injection.', 'armGroupLabels': ['Laser']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Melbourne', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site'}, {'city': 'Paris', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Florence', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Novartis Investigational Site', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Upton', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.61466, 'lon': -1.28677}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}