Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:42 PM
Study NCT ID:
NCT01427751
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2011-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012170', 'term': 'Retinal Vein Occlusion'}, {'id': 'D008269', 'term': 'Macular Edema'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D000069579', 'term': 'Ranibizumab'}], 'ancestors': [{'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'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'title': 'Allergan Inc.,', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to release and can embargo communications regarding trial results for a period that is less than or equal to 120 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 60 Weeks', 'description': 'Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.', 'eventGroups': [{'id': 'EG000', 'title': 'Ozurdex®', 'description': 'Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.', 'otherNumAtRisk': 153, 'otherNumAffected': 127, 'seriousNumAtRisk': 153, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Lucentis®', 'description': 'Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.', 'otherNumAtRisk': 150, 'otherNumAffected': 104, 'seriousNumAtRisk': 150, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 17}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Macular oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lenticular opacities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ocular hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bradyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Agitated depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Catheter site related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ocular hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Endophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Subdural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Best Corrected Visual Acuity (BCVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex®', 'description': 'Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.'}, {'id': 'OG001', 'title': 'Lucentis®', 'description': 'Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.'}], 'classes': [{'title': 'Baseline (n=153,153)', 'categories': [{'measurements': [{'value': '56.6', 'spread': '10.89', 'groupId': 'OG000'}, {'value': '59.2', 'spread': '10.92', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Month 12 (n=153,151)', 'categories': [{'measurements': [{'value': '7.9', 'spread': '14.42', 'groupId': 'OG000'}, {'value': '16.9', 'spread': '12.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity) A positive change from Baseline (more letters read correctly) indicates improvement.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the intent-to-treat population, all randomized participants, with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex®', 'description': 'Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.'}, {'id': 'OG001', 'title': 'Lucentis®', 'description': 'Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.'}], 'classes': [{'title': 'Baseline (n=149, 149)', 'categories': [{'measurements': [{'value': '553.2', 'spread': '170.15', 'groupId': 'OG000'}, {'value': '561.0', 'spread': '188.93', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Month 12 (n=140,144)', 'categories': [{'measurements': [{'value': '-219.2', 'spread': '180.51', 'groupId': 'OG000'}, {'value': '-253.5', 'spread': '197.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at Baseline and Month 12. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'microns', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the intent-to-treat population, all randomized participants, with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With 15-or-More Letter Improvement in BCVA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex®', 'description': 'Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.'}, {'id': 'OG001', 'title': 'Lucentis®', 'description': 'Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.8', 'groupId': 'OG000'}, {'value': '59.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 12', 'description': 'BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the intent-to-treat population, all randomized participants, with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With a 15-or-More Letter Decrease in BCVA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex®', 'description': 'Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.'}, {'id': 'OG001', 'title': 'Lucentis®', 'description': 'Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 12', 'description': 'BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the intent-to-treat population, all randomized participants, with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Time to BCVA Improvement of 15-or-More Letters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex®', 'description': 'Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.'}, {'id': 'OG001', 'title': 'Lucentis®', 'description': 'Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.7', 'spread': '79.68', 'groupId': 'OG000'}, {'value': '82.0', 'spread': '93.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 Months', 'description': 'BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The time in days to BCVA improvement of 15-or-More letters.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the intent-to-treat population, all randomized participants, with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex®', 'description': 'Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.'}, {'id': 'OG001', 'title': 'Lucentis®', 'description': 'Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.'}], 'classes': [{'title': 'Baseline (n=143,139)', 'categories': [{'measurements': [{'value': '78.1', 'spread': '16.58', 'groupId': 'OG000'}, {'value': '80.7', 'spread': '14.34', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Month 12 (n=143, 139)', 'categories': [{'measurements': [{'value': '3.5', 'spread': '12.21', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '13.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'The VFQ-25 includes 25 vision-targeted questions plus one general health question which assess visual impairment on functioning and specific aspects of health-related quality of life for a total possible composite score of 0 (worst) to 100 (best functionality). A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the intent-to-treat population, all randomized participants, with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ozurdex®', 'description': 'Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.'}, {'id': 'OG001', 'title': 'Lucentis®', 'description': 'Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'Treatment failure was defined as withdrawal of the participant from treatment or from the study by the investigator before the final visit because of a lack of efficacy.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population included all randomized participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ozurdex®', 'description': 'Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.'}, {'id': 'FG001', 'title': 'Lucentis®', 'description': 'Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '154'}, {'groupId': 'FG001', 'numSubjects': '153'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '139'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'No further treatment benefit expected', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal of consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other miscellaneous reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ozurdex®', 'description': 'Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.'}, {'id': 'BG001', 'title': 'Lucentis®', 'description': 'Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.4', 'spread': '10.58', 'groupId': 'BG000'}, {'value': '65.5', 'spread': '12.04', 'groupId': 'BG001'}, {'value': '67.0', 'spread': '11.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 307}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2014-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-09', 'studyFirstSubmitDate': '2011-08-31', 'resultsFirstSubmitDate': '2015-11-03', 'studyFirstSubmitQcDate': '2011-09-01', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-01-19', 'studyFirstPostDateStruct': {'date': '2011-09-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Best Corrected Visual Acuity (BCVA)', 'timeFrame': 'Baseline, Month 12', 'description': 'BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity) A positive change from Baseline (more letters read correctly) indicates improvement.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT)', 'timeFrame': 'Baseline, Month 12', 'description': 'Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at Baseline and Month 12. A negative change from Baseline indicates improvement.'}, {'measure': 'Percentage of Patients With 15-or-More Letter Improvement in BCVA', 'timeFrame': 'Baseline, Month 12', 'description': 'BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved.'}, {'measure': 'Percentage of Patients With a 15-or-More Letter Decrease in BCVA', 'timeFrame': 'Baseline, Month 12', 'description': 'BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).'}, {'measure': 'Time to BCVA Improvement of 15-or-More Letters', 'timeFrame': '12 Months', 'description': 'BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The time in days to BCVA improvement of 15-or-More letters.'}, {'measure': 'Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)', 'timeFrame': 'Baseline, Month 12', 'description': 'The VFQ-25 includes 25 vision-targeted questions plus one general health question which assess visual impairment on functioning and specific aspects of health-related quality of life for a total possible composite score of 0 (worst) to 100 (best functionality). A positive change from Baseline indicates improvement.'}, {'measure': 'Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure', 'timeFrame': '12 Months', 'description': 'Treatment failure was defined as withdrawal of the participant from treatment or from the study by the investigator before the final visit because of a lack of efficacy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Retinal Vein Occlusion', 'Macular Edema']}, 'referencesModule': {'references': [{'pmid': '29631435', 'type': 'BACKGROUND', 'citation': 'Bandello F, Augustin A, Tufail A, Leaback R. A 12-month, multicenter, parallel group comparison of dexamethasone intravitreal implant versus ranibizumab in branch retinal vein occlusion. Eur J Ophthalmol. 2018 Nov;28(6):697-705. doi: 10.1177/1120672117750058. Epub 2018 Apr 9.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex®) compared to ranibizumab (Lucentis®) in patients with branch retinal vein occlusion (BRVO).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of branch retinal vein occlusion in at least one eye\n* Visual acuity between 20/400 to 20/40\n\nExclusion Criteria:\n\n* Active eye infection\n* Ocular hypertension which is not controlled on monotherapy (one medication)\n* Anticipated need for eye surgery during the study\n* Cataract surgery in either eye within 3 months\n* Eye surgery including laser of any type within 6 months\n* Anti-VEGF treatment in either eye (eg, Lucentis®) within 3 months or systemic anti-VEGF treatment (eg, Avastin) within 6 months\n* Use of ocular steroids within 3 months\n* Use of steroids (except for inhaled or intranasal) within 1 month or anticipated use during the study'}, 'identificationModule': {'nctId': 'NCT01427751', 'briefTitle': 'Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'MAF-AGN-OPH-RET-004'}, 'secondaryIdInfos': [{'id': '2010-023900-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ozurdex®', 'description': 'Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter.', 'interventionNames': ['Drug: dexamethasone intravitreal implant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lucentis®', 'description': 'Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria.', 'interventionNames': ['Biological: ranibizumab']}], 'interventions': [{'name': 'dexamethasone intravitreal implant', 'type': 'DRUG', 'otherNames': ['Ozurdex®'], 'description': 'Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter.', 'armGroupLabels': ['Ozurdex®']}, {'name': 'ranibizumab', 'type': 'BIOLOGICAL', 'otherNames': ['Lucentis®'], 'description': 'Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria.', 'armGroupLabels': ['Lucentis®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Munich', 'country': 'Germany', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Tel Aviv', 'country': 'Israel', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Milan', 'country': 'Italy', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}