Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-28 @ 7:48 AM
Study NCT ID:
NCT01396057
Status:
COMPLETED
Last Update Posted:
2014-08-07
First Post:
2011-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Branch Retinal Vein Occlusion (BRVO)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D008269', 'term': 'Macular Edema'}, {'id': 'D012170', 'term': 'Retinal Vein Occlusion'}], 'ancestors': [{'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialandresults.registries@novartis.com', '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 or disclosure of trial results in their entirety", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ranibizumab', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally', 'otherNumAtRisk': 126, 'otherNumAffected': 71, 'seriousNumAtRisk': 126, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Dexamethasone', 'description': 'Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months', 'otherNumAtRisk': 118, 'otherNumAffected': 89, 'seriousNumAtRisk': 118, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'ABNORMAL SENSATION IN EYE (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'BLEPHARITIS (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'BLEPHARITIS (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CATARACT (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CONJUNCTIVAL HAEMORRHAGE (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CONJUNCTIVAL IRRITATION (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CONJUNCTIVITIS (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'EYE DISCHARGE (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'EYE IRRITATION (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'EYE IRRITATION (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'EYE PAIN (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 13}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'EYELID OEDEMA (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'FOREIGN BODY SENSATION IN EYES (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'GLAUCOMA (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'LACRIMATION INCREASED (Fellow eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'LACRIMATION INCREASED (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'MACULAR OEDEMA (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'OCULAR DISCOMFORT (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'OCULAR HYPERAEMIA (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 21}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'OCULAR HYPERTENSION (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'RETINAL EXUDATES (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'VISION BLURRED (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'VISUAL ACUITY REDUCED (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'VITREOUS DETACHMENT (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'VITREOUS FLOATERS (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CYSTITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'LOWER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'BLOOD GLUCOSE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'INTRAOCULAR PRESSURE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'INTRAOCULAR PRESSURE INCREASED (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'OROPHARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'VASCULAR SHUNT (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'ATRIOVENTRICULAR BLOCK SECOND DEGREE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'BRADYARRHYTHMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CONJUNCTIVITIS (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'OCULAR HYPERTENSION (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ABDOMINAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'INGUINAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'LARGE INTESTINE POLYP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'RECTAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'UMBILICAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'APPENDICITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CELLULITIS (Study eye)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'FOOT FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'KIDNEY RUPTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PERIRENAL HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ROAD TRAFFIC ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'SPLENIC INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'TYPE 2 DIABETES MELLITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'INTERVERTEBRAL DISC PROTRUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'RHEUMATIC DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PROSTATE CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'RENAL CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'DIABETIC NEPHROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'NEPHROLITHIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'RENAL FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'URETHRAL PROLAPSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'SLEEP APNOEA SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'CIRCULATORY COLLAPSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '2.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Average Best Corrected Visual Acuity (BCVA) Change From Month 1 Through Month 6 to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG001', 'title': 'Dexamethasone', 'description': 'Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '9.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, month 6', 'description': 'the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6', 'unitOfMeasure': 'Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had 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'}, {'type': 'SECONDARY', 'title': 'Mean BCVA Change From Baseline to Endpoints Month 1 to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG001', 'title': 'Dexamethasone', 'description': 'Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '16.18', 'groupId': 'OG000', 'lowerLimit': '14.04', 'upperLimit': '18.32'}, {'value': '8.10', 'groupId': 'OG001', 'lowerLimit': '5.79', 'upperLimit': '10.40'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, month 6', 'description': 'The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors', 'unitOfMeasure': 'Letters (EDTRS)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had 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'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters After 6 Month Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG001', 'title': 'Dexamethasone', 'description': 'Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months'}], 'classes': [{'title': 'Gain≥15 letters', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Loss of ≥15 letters', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Gain ≥10 letters', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Loss of ≥10 letters', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Gain ≥5 letters', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'Loss of ≥5 letters', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 6 month', 'description': 'BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 15, 10 or 5 more letters of visual acuity at month 6 as compared with baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had 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'}, {'type': 'SECONDARY', 'title': 'Time to Achieve a Significant Improvement ≥ 15 Letters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG001', 'title': 'Dexamethasone', 'description': 'Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '84'}, {'value': '64', 'groupId': 'OG001', 'lowerLimit': '59', 'upperLimit': '126'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, month 6', 'description': 'The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts', 'unitOfMeasure': 'Time to event (Days)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had 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'}, {'type': 'SECONDARY', 'title': 'Change Over Time in BCVA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG001', 'title': 'Dexamethasone', 'description': 'Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months'}], 'classes': [{'title': 'Month 1', 'categories': [{'measurements': [{'value': '10.35', 'groupId': 'OG000', 'lowerLimit': '8.53', 'upperLimit': '12.17'}, {'value': '10.44', 'groupId': 'OG001', 'lowerLimit': '8.48', 'upperLimit': '12.40'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '13.84', 'groupId': 'OG000', 'lowerLimit': '12.04', 'upperLimit': '15.64'}, {'value': '12.62', 'groupId': 'OG001', 'lowerLimit': '10.69', 'upperLimit': '14.56'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '15.52', 'groupId': 'OG000', 'lowerLimit': '13.44', 'upperLimit': '17.59'}, {'value': '9.16', 'groupId': 'OG001', 'lowerLimit': '6.92', 'upperLimit': '11.39'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '14.39', 'groupId': 'OG000', 'lowerLimit': '12.38', 'upperLimit': '16.41'}, {'value': '8.59', 'groupId': 'OG001', 'lowerLimit': '6.42', 'upperLimit': '10.76'}]}]}, {'title': 'Month 5', 'categories': [{'measurements': [{'value': '14.65', 'groupId': 'OG000', 'lowerLimit': '12.52', 'upperLimit': '16.78'}, {'value': '9.08', 'groupId': 'OG001', 'lowerLimit': '6.79', 'upperLimit': '11.37'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '16.18', 'groupId': 'OG000', 'lowerLimit': '14.04', 'upperLimit': '18.32'}, {'value': '8.10', 'groupId': 'OG001', 'lowerLimit': '5.79', 'upperLimit': '10.40'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, month 6', 'description': 'The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors', 'unitOfMeasure': 'Letters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had 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'}, {'type': 'SECONDARY', 'title': 'Change Over Time of the Central Retinal Thickness (CRT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG001', 'title': 'Dexamethasone', 'description': 'Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-230.6', 'spread': '169.3', 'groupId': 'OG000'}, {'value': '-112.3', 'spread': '172.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, month 6', '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': 'µm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had 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'}, {'type': 'SECONDARY', 'title': 'Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG001', 'title': 'Dexamethasone', 'description': 'Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '12.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, month 6', 'description': 'The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. 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': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had 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'}, {'type': 'SECONDARY', 'title': 'Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG001', 'title': 'Dexamethasone', 'description': 'Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months'}], 'classes': [{'title': 'SF-36 physical component (n=121,114)', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '5.7', 'groupId': 'OG001'}]}]}, {'title': 'SF-36 mental component (n=121,114)', 'categories': [{'measurements': [{'value': '3.3', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '9.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, month 6', 'description': 'SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. observed is only described in this analysis.'}, {'type': 'SECONDARY', 'title': 'Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG001', 'title': 'Dexamethasone', 'description': 'Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '15.2', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '15.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, month 6', 'description': 'The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Observed participants are only described in this analysis'}, {'type': 'SECONDARY', 'title': 'Rate of the Internal Ocular Pressure (IOP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranibizumab', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'OG001', 'title': 'Dexamethasone', 'description': 'Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, month 6', 'description': 'The proportion of patients with ≥ 10% increase in IOP compared to baseline at any post-baseline visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set consisted of all patients from the RS who had received at least one application of study treatment and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no adverse events also constituted a safety assessment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ranibizumab', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'FG001', 'title': 'Dexamethasone', 'description': 'Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '118'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Consent withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ranibizumab', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally'}, {'id': 'BG001', 'title': 'Dexamethasone', 'description': 'Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.7', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '65.6', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '65.6', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 244}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-04', 'studyFirstSubmitDate': '2011-07-14', 'resultsFirstSubmitDate': '2014-06-13', 'studyFirstSubmitQcDate': '2011-07-15', 'lastUpdatePostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-13', 'studyFirstPostDateStruct': {'date': '2011-07-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Average Best Corrected Visual Acuity (BCVA) Change From Month 1 Through Month 6 to Baseline', 'timeFrame': 'Baseline, month 6', 'description': 'the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6'}], 'secondaryOutcomes': [{'measure': 'Mean BCVA Change From Baseline to Endpoints Month 1 to Month 6', 'timeFrame': 'Baseline, month 6', 'description': 'The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors'}, {'measure': 'Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters After 6 Month Treatment', 'timeFrame': 'Baseline, 6 month', 'description': 'BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 15, 10 or 5 more letters of visual acuity at month 6 as compared with baseline'}, {'measure': 'Time to Achieve a Significant Improvement ≥ 15 Letters', 'timeFrame': 'Baseline, month 6', 'description': 'The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts'}, {'measure': 'Change Over Time in BCVA', 'timeFrame': 'baseline, month 6', 'description': 'The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors'}, {'measure': 'Change Over Time of the Central Retinal Thickness (CRT)', 'timeFrame': 'Baseline, month 6', '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': 'Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires', 'timeFrame': 'Baseline, month 6', 'description': 'The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. 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': 'Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires', 'timeFrame': 'Baseline, month 6', 'description': 'SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health'}, {'measure': 'Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires', 'timeFrame': 'Baseline, month 6', 'description': 'The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state.'}, {'measure': 'Rate of the Internal Ocular Pressure (IOP)', 'timeFrame': 'Baseline, month 6', 'description': 'The proportion of patients with ≥ 10% increase in IOP compared to baseline at any post-baseline visit.'}]}, 'conditionsModule': {'keywords': ['Visual impairment', 'macular edema', 'branch retinal vein occlusion', 'Dexamethasone implant', 'Ranibizumab'], 'conditions': ['Visual Impairment', 'Macular Edema', 'Branch Retinal Vein Occlusion']}, 'referencesModule': {'references': [{'pmid': '32633861', 'type': 'DERIVED', 'citation': 'Shalchi Z, Mahroo O, Bunce C, Mitry D. Anti-vascular endothelial growth factor for macular oedema secondary to branch retinal vein occlusion. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD009510. doi: 10.1002/14651858.CD009510.pub3.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant after 6 months of treatment. In the study arm Ranibizumab will be given monthly in a pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with sham injections PRN afterwards.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with visual impairment due to macular edema following BRVO\n* Diagnosis of BRVO at maximum 6 months prior to Screening\n* BCVA using ETDRS charts of 20/40 to 20/400 in the study eye\n\nExclusion Criteria:\n\n* Media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs\n* Central retinal thickness (CRT) \\< 250 µm in the study eye\n* Prior episode of RVO in the study eye\n* Active formation of new vessels in the study eye\n* Anti-VEGF-treatment in the study or the fellow eye 3 months prior to Baseline\n* IOP ≥ 30mmHg or uncontrolled glaucoma; patients may be re-screened after 1 month if they have undergone glaucoma treatment\n* Improvement of \\> 10 letters on BCVA between Screening and Baseline\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01396057', 'acronym': 'COMRADE-B', 'briefTitle': 'Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Branch Retinal Vein Occlusion (BRVO)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 6-month Multicenter, Randomized, Double-masked Phase IIIb-study Comparing the Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Visual Impairment Due to Macular Edema Following Branch Retinal Vein Occlusion (BRVO)', 'orgStudyIdInfo': {'id': 'CRFB002EDE17'}, 'secondaryIdInfos': [{'id': '2011-001019-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ranibizumab', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally', 'interventionNames': ['Drug: Ranibizumab']}, {'type': 'SHAM_COMPARATOR', 'label': 'Dexamethasone', 'description': 'Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months', 'interventionNames': ['Other: Dexamethasone Implant', 'Other: Sham injection']}], 'interventions': [{'name': 'Ranibizumab', 'type': 'DRUG', 'description': 'Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally. 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