Viewing Study NCT00445003

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Ignite Creation Date: 2025-12-24 @ 7:18 PM
Ignite Modification Date: 2026-01-01 @ 7:09 PM
Study NCT ID: NCT00445003
Status: COMPLETED
Last Update Posted: 2016-08-26
First Post: 2007-03-06
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}, {'id': 'D014222', 'term': 'Triamcinolone Acetonide'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'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': 'D014221', 'term': 'Triamcinolone'}, {'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': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aglassman@jaeb.org', 'phone': '813-975-8690', 'title': 'Adam R. Glassman, Director DRCR.net Coordinating Center', 'organization': 'Jaeb Center for Health Research'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through 14-week Primary outcome visit', 'description': 'Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \\>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.', 'eventGroups': [{'id': 'EG000', 'title': 'Sham Injection', 'description': 'Sham injection at baseline and 4 weeks', 'otherNumAtRisk': 133, 'otherNumAffected': 57, 'seriousNumAtRisk': 133, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': '0.5mg Ranibizumab', 'description': 'Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks', 'otherNumAtRisk': 116, 'otherNumAffected': 50, 'seriousNumAtRisk': 116, 'seriousNumAffected': 15}, {'id': 'EG002', 'title': '4-mg Triamcinolone Acetonided', 'description': '4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks', 'otherNumAtRisk': 115, 'otherNumAffected': 66, 'seriousNumAtRisk': 115, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Intraocular pressure increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Myodesopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Coronary arterial stant insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Diabetic gastroparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Endophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Heart rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Transient ischaemic attach', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 133, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 115, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Injection', 'description': 'Sham injection at baseline and 4 weeks'}, {'id': 'OG001', 'title': '0.5mg Ranibizumab', 'description': 'Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks'}, {'id': 'OG002', 'title': '4-mg Triamcinolone Acetonided', 'description': '4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-4', 'spread': '14', 'groupId': 'OG000'}, {'value': '1', 'spread': '11', 'groupId': 'OG001'}, {'value': '2', 'spread': '11', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.6', 'ciLowerLimit': '2.2', 'ciUpperLimit': '9.0', 'pValueComment': 'adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between two study eyes', 'estimateComment': 'adjusted for multiple comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.7', 'ciLowerLimit': '3.2', 'ciUpperLimit': '10.1', 'pValueComment': 'adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between two study eyes', 'estimateComment': 'adjusted for multiple comparisons', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 14 weeks', 'description': 'Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.', 'unitOfMeasure': 'Letter Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with 2 study eyes enrolled each eye in a different arm. Each arm includes no more than 1 study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm. Analysis followed intention to treat principle; eyes without 14-week data, the Last Observation Carried Forward method was used.'}, {'type': 'SECONDARY', 'title': 'Additional Treatments for Diabetic Macular Edema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Injection', 'description': 'Sham injection at baseline and 4 weeks'}, {'id': 'OG001', 'title': '0.5mg Ranibizumab', 'description': 'Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks'}, {'id': 'OG002', 'title': '4-mg Triamcinolone Acetonided', 'description': '4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks'}], 'classes': [{'title': 'Bevacizumab', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Ranibizumab', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Triamcinolone', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Pegaptanib', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Laser', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Vitrectomy', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Bevacizumab plus Triamcinolone', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Ranibizumab plus Triamcinolone', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Bevacizumab plus laser', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Ranibizumab plus laser', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Triamcinolone plus laser', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Pegaptanib plus laser', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Triamcinolone plus vitrectomy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pegaptanib plus vitrectomy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Triamcinolone plus laser plus vitrectomy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Bevacizumab plus triamcinolone plus laser', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 weeks to 56-weeks', 'description': 'Each combination of treatment is only counted once per treatment eye. Participants could have 2 study eyes, with random assignments to different treatments.', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Optical Coherence Tomography Central Subfield Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Injection', 'description': 'Sham injection at baseline and 4 weeks'}, {'id': 'OG001', 'title': '0.5mg Ranibizumab', 'description': 'Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks'}, {'id': 'OG002', 'title': '4-mg Triamcinolone Acetonided', 'description': '4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '362', 'groupId': 'OG000', 'lowerLimit': '287', 'upperLimit': '484'}, {'value': '312', 'groupId': 'OG001', 'lowerLimit': '259', 'upperLimit': '453'}, {'value': '265', 'groupId': 'OG002', 'lowerLimit': '230', 'upperLimit': '304'}]}]}], 'analyses': [{'pValue': '<.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-35', 'ciLowerLimit': '-64', 'ciUpperLimit': '-6', 'pValueComment': 'Adjusted for baseline optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes', 'estimateComment': 'adjusted for multiple comparisons', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-100', 'ciLowerLimit': '-128', 'ciUpperLimit': '-71', 'pValueComment': 'adjusted for baseline optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes', 'estimateComment': 'adjusted for multiple comparisons', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 14 weeks', 'unitOfMeasure': 'Microns', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.'}, {'type': 'SECONDARY', 'title': 'Total Optical Coherence Tomography Retinal Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Injection', 'description': 'Sham injection at baseline and 4 weeks'}, {'id': 'OG001', 'title': '0.5mg Ranibizumab', 'description': 'Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks'}, {'id': 'OG002', 'title': '4-mg Triamcinolone Acetonided', 'description': '4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '9.7', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '7.9', 'spread': '1.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 14-weeks', 'description': 'Missing/ungradable as follows: Sham = 49, Ranibizumab = 37, Triamcinolone = 39. Visits occured between 70 days and 153 days from randomization adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes. Confidence intervals are adjusted for multiple comparisons.', 'unitOfMeasure': 'mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with 2 study eyes enrolled each eye in a different arm. Therefore, each arm includes no more than 1 eye for a given participant, and thus the numbers of eyes is equal to number of participants.'}, {'type': 'SECONDARY', 'title': 'Change in Visual Acuity From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Injection', 'description': 'Sham injection at baseline and 4 weeks'}, {'id': 'OG001', 'title': '0.5mg Ranibizumab', 'description': 'Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks'}, {'id': 'OG002', 'title': '4-mg Triamcinolone Acetonided', 'description': '4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-6', 'spread': '17', 'groupId': 'OG000'}, {'value': '-4', 'spread': '21', 'groupId': 'OG001'}, {'value': '-5', 'spread': '16', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '-3.7', 'ciUpperLimit': '7.5', 'pValueComment': 'Adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes', 'estimateComment': 'adjusted for multiple comparisons', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.63', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '-4.4', 'ciUpperLimit': '6.8', 'pValueComment': 'Adjusted for baseline visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes', 'estimateComment': 'adjusted for multiple comparisons', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 56-weeks', 'description': 'Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.', 'unitOfMeasure': 'Letter Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.'}, {'type': 'SECONDARY', 'title': 'Eyes With Anti-vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Injection', 'description': 'Sham injection at baseline and 4 weeks'}, {'id': 'OG001', 'title': '0.5mg Ranibizumab', 'description': 'Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks'}, {'id': 'OG002', 'title': '4-mg Triamcinolone Acetonided', 'description': '4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 weeks to 56-weeks', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.'}, {'type': 'SECONDARY', 'title': 'Number of Eyes With Additional Number of Treatments for Diabetic Macular Edema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Injection', 'description': 'Sham injection at baseline and 4 weeks'}, {'id': 'OG001', 'title': '0.5mg Ranibizumab', 'description': 'Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks'}, {'id': 'OG002', 'title': '4-mg Triamcinolone Acetonided', 'description': '4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 weeks to 56-weeks', 'description': 'Treatments include any type or combination of treatment for diabetic macular edema. Eyes were only counted once, when receiving a combination of treatments.', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.'}, {'type': 'SECONDARY', 'title': 'Change in Optical Coherence Tomography Retinal Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Injection', 'description': 'Sham injection at baseline and 4 weeks'}, {'id': 'OG001', 'title': '0.5mg Ranibizumab', 'description': 'Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks'}, {'id': 'OG002', 'title': '4-mg Triamcinolone Acetonided', 'description': '4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '1.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.2', 'pValueComment': 'adjusted for baseline retinal volume, optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes', 'estimateComment': 'adjusted for multiple comparisons', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '-1.3', 'pValueComment': 'adjusted for baseline retinal volume, optical coherence tomography retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes', 'estimateComment': 'adjusted for multiple comparisons', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Missing or un-gradable data as follows for the sham plus focal/grid/panretinal photocoagulation laser, triamcinolone plus focal/grid panretinal photocoagulation laser, and Ranibizumab groups were 49, 37, and 39, respectively', 'unitOfMeasure': 'mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with two study eyes enrolled each eye in a different treatment group. Therefore, each treatment group/arm includes no more than one study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sham Injection', 'description': 'Sham injection at baseline and 4 weeks'}, {'id': 'FG001', 'title': '0.5mg Ranibizumab', 'description': 'Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks'}, {'id': 'FG002', 'title': '4-mg Triamcinolone Acetonided', 'description': '4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '113'}, {'groupId': 'FG002', 'numSubjects': '109'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '103'}, {'groupId': 'FG002', 'numSubjects': '105'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Missed Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Dropped', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Data from 1 clinical site where a majority of eyes were judged not to meet the Optical Coherence Tomography eligibility criterion of central subfield \\>=250 microns when graded manually at a central reading center (14 eyes of 10 subjects) are excluded from all analysis except for safety data.', 'preAssignmentDetails': 'Participants with 2 study eyes enrolled each eye in a different arm. Each treatment arm includes no more than 1 study eye for a given participant, and thus the numbers of eyes is equal to the number of participants in each arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Sham Injection', 'description': 'Sham injection at baseline and 4 weeks'}, {'id': 'BG001', 'title': '0.5mg Ranibizumab', 'description': 'Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks'}, {'id': 'BG002', 'title': '4-mg Triamcinolone Acetonided', 'description': '4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000', 'lowerLimit': '45', 'upperLimit': '61'}, {'value': '57', 'groupId': 'BG001', 'lowerLimit': '48', 'upperLimit': '64'}, {'value': '58', 'groupId': 'BG002', 'lowerLimit': '49', 'upperLimit': '64'}, {'value': '56', 'groupId': 'BG003', 'lowerLimit': '45', 'upperLimit': '64'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '209', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '209', 'groupId': 'BG003'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Optical coherence tomography subretinal fluid present (questionable or definite)', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '252', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Based on standard reading center grading', 'unitOfMeasure': 'Eyes'}, {'title': 'Classification of diabetic macular edema on clinical exam', 'classes': [{'title': "Predominantly Focal'", 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}]}]}, {'title': 'Neither perdominantly focal or diffuse', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}]}, {'title': 'Predominantly diffuse', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '205', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Eyes'}, {'title': 'Intraocular Pressure', 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000', 'lowerLimit': '13', 'upperLimit': '18'}, {'value': '16', 'groupId': 'BG001', 'lowerLimit': '14', 'upperLimit': '18'}, {'value': '15', 'groupId': 'BG002', 'lowerLimit': '13', 'upperLimit': '18'}, {'value': '15', 'groupId': 'BG003', 'lowerLimit': '13', 'upperLimit': '18'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Diabetes Type', 'classes': [{'title': 'Type 1', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}, {'title': 'Type 2', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '289', 'groupId': 'BG003'}]}]}, {'title': 'Uncertain', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of diabetes', 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000', 'lowerLimit': '8', 'upperLimit': '21'}, {'value': '15', 'groupId': 'BG001', 'lowerLimit': '10', 'upperLimit': '21'}, {'value': '15', 'groupId': 'BG002', 'lowerLimit': '10', 'upperLimit': '19'}, {'value': '15', 'groupId': 'BG003', 'lowerLimit': '8', 'upperLimit': '21'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Hemoglobin A1c', 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'groupId': 'BG000', 'lowerLimit': '7.0', 'upperLimit': '9.6'}, {'value': '8.1', 'groupId': 'BG001', 'lowerLimit': '7.1', 'upperLimit': '9.9'}, {'value': '8.1', 'groupId': 'BG002', 'lowerLimit': '7.0', 'upperLimit': '9.7'}, {'value': '8.0', 'groupId': 'BG003', 'lowerLimit': '7.0', 'upperLimit': '9.9'}]}]}], 'paramType': 'MEDIAN', 'description': 'Missing hemoglobin A1c data for study participants in the sham, ranibizumab, and triamcinolone, respectively: 4, 10, 7', 'unitOfMeasure': 'Percentage', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Prior Cardiovascular event', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '261', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '267', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Number of study eyes', 'classes': [{'title': '1 study eye', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '293', 'groupId': 'BG003'}]}]}, {'title': '2 study eyes', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Panretinal scatter photocoagulation', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '290', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Eyes'}, {'title': 'prior treatment for diabetic macular edema', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '227', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Eyes'}, {'title': 'Prior laser for diabetic macular edema', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '236', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Eyes'}, {'title': 'Prior intravitreal triamcinolone for diabetic macular edema', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '332', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Eyes'}, {'title': 'Prior vitrectomy for diabetic macular edema', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '343', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Eyes'}, {'title': 'Prior peribulbar triamcinolone for diabetic macular edema', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '343', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Eyes'}, {'title': 'prior anti- vascular endothelial growth factor for diabetic macular edema', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '335', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Eyes'}, {'title': 'Currently on intraocular pressure lowering medication for glaucoma or ocular hypertension', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '342', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Eyes'}, {'title': 'Lens status (clinical examination)', 'classes': [{'title': 'Phakic', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '301', 'groupId': 'BG003'}]}]}, {'title': 'Pseudophakic', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Eyes'}, {'title': 'Baseline visual acuity by randomization strata', 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000', 'lowerLimit': '52', 'upperLimit': '75'}, {'value': '68', 'groupId': 'BG001', 'lowerLimit': '56', 'upperLimit': '75'}, {'value': '67', 'groupId': 'BG002', 'lowerLimit': '59', 'upperLimit': '75'}, {'value': '67', 'groupId': 'BG003', 'lowerLimit': '52', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'description': 'Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.', 'unitOfMeasure': 'Letter Score', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Central subfield thickness on optical coherence tomography', 'classes': [{'categories': [{'measurements': [{'value': '355', 'groupId': 'BG000', 'lowerLimit': '285', 'upperLimit': '510'}, {'value': '352', 'groupId': 'BG001', 'lowerLimit': '283', 'upperLimit': '476'}, {'value': '359', 'groupId': 'BG002', 'lowerLimit': '271', 'upperLimit': '472'}, {'value': '355', 'groupId': 'BG003', 'lowerLimit': '283', 'upperLimit': '510'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Microns', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Retinal volume on optical coherence tomography', 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'groupId': 'BG000', 'lowerLimit': '8.4', 'upperLimit': '10.6'}, {'value': '9.2', 'groupId': 'BG001', 'lowerLimit': '8.3', 'upperLimit': '11.0'}, {'value': '9.1', 'groupId': 'BG002', 'lowerLimit': '8.1', 'upperLimit': '10.0'}, {'value': '9.2', 'groupId': 'BG003', 'lowerLimit': '8.1', 'upperLimit': '11'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cubic millimetre', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Optical coherence tomography cystoid abnormality (questionable or definite)', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '300', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'From reading center grading.', 'unitOfMeasure': 'Eyes'}, {'title': 'Early Treatment Diabetic Retinopath Study Retinopathy severity level from photograph grading', 'classes': [{'title': 'Level 35, 43 (Mild/Moderate NPDR)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'Level 47 (Moderately severe NPDR)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}]}, {'title': 'Level 53 (Severe NPDR)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}, {'title': 'Level 60 (Prior PRP without active neovascularizat', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Level 61 (Mild/Moderate PDR)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}]}]}, {'title': 'Level 71, 75 (High-risk PDR)', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}]}]}, {'title': 'cannot grade', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Criteria are based on the ETDRS fundus photographic risk factors for the progression of diabetic retinopathy. ETDRS report no. 12. Ophthalmology 1991; 98:823-833', 'unitOfMeasure': 'Eyes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 333}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'dispFirstSubmitDate': '2011-01-14', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-25', 'studyFirstSubmitDate': '2007-03-06', 'dispFirstSubmitQcDate': '2011-03-15', 'resultsFirstSubmitDate': '2011-04-14', 'studyFirstSubmitQcDate': '2007-03-06', 'dispFirstPostDateStruct': {'date': '2011-03-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-06-14', 'studyFirstPostDateStruct': {'date': '2007-03-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 14 Weeks', 'timeFrame': 'baseline to 14 weeks', 'description': 'Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.'}], 'secondaryOutcomes': [{'measure': 'Additional Treatments for Diabetic Macular Edema', 'timeFrame': '14 weeks to 56-weeks', 'description': 'Each combination of treatment is only counted once per treatment eye. Participants could have 2 study eyes, with random assignments to different treatments.'}, {'measure': 'Change in Optical Coherence Tomography Central Subfield Thickness', 'timeFrame': 'Baseline to 14 weeks'}, {'measure': 'Total Optical Coherence Tomography Retinal Volume', 'timeFrame': 'Baseline to 14-weeks', 'description': 'Missing/ungradable as follows: Sham = 49, Ranibizumab = 37, Triamcinolone = 39. Visits occured between 70 days and 153 days from randomization adjusted for baseline optical coherence tomography (OCT) retinal volume, OCT retinal thickness and visual acuity, number of planned panretinal photocoagulation sittings, and correlation between 2 study eyes. Confidence intervals are adjusted for multiple comparisons.'}, {'measure': 'Change in Visual Acuity From Baseline', 'timeFrame': 'baseline to 56-weeks', 'description': 'Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.'}, {'measure': 'Eyes With Anti-vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema', 'timeFrame': '14 weeks to 56-weeks'}, {'measure': 'Number of Eyes With Additional Number of Treatments for Diabetic Macular Edema', 'timeFrame': '14 weeks to 56-weeks', 'description': 'Treatments include any type or combination of treatment for diabetic macular edema. Eyes were only counted once, when receiving a combination of treatments.'}, {'measure': 'Change in Optical Coherence Tomography Retinal Volume', 'timeFrame': 'Baseline to 14 weeks', 'description': 'Missing or un-gradable data as follows for the sham plus focal/grid/panretinal photocoagulation laser, triamcinolone plus focal/grid panretinal photocoagulation laser, and Ranibizumab groups were 49, 37, and 39, respectively'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetic Retinopathy', 'Diabetic Macular Edema', 'Lucentis', 'Ranibizumab', 'Triamcinolone', 'Panretinal Photocoagulation', 'Combination Therapy', 'pdr'], 'conditions': ['Proliferative Diabetic Retinopathy', 'Diabetic Macular Edema']}, 'referencesModule': {'references': [{'pmid': '22136692', 'type': 'BACKGROUND', 'citation': 'Diabetic Retinopathy Clinical Research Network; Writing Committee; Aiello LP, Beck RW, Bressler NM, Browning DJ, Chalam KV, Davis M, Ferris FL 3rd, Glassman AR, Maturi RK, Stockdale CR, Topping TM. Rationale for the diabetic retinopathy clinical research network treatment protocol for center-involved diabetic macular edema. Ophthalmology. 2011 Dec;118(12):e5-14. doi: 10.1016/j.ophtha.2011.09.058.'}, {'pmid': '22332211', 'type': 'BACKGROUND', 'citation': 'Glassman AR, Stockdale CR, Beck RW, Baker C, Bressler NM; Diabetic Retinopathy Clinical Research Network. Evaluation of masking study participants to intravitreal injections in a randomized clinical trial. Arch Ophthalmol. 2012 Feb;130(2):190-4. doi: 10.1001/archophthalmol.2011.387.'}, {'pmid': '22965591', 'type': 'BACKGROUND', 'citation': 'Bressler SB, Qin H, Beck RW, Chalam KV, Kim JE, Melia M, Wells JA 3rd; Diabetic Retinopathy Clinical Research Network. Factors associated with changes in visual acuity and central subfield thickness at 1 year after treatment for diabetic macular edema with ranibizumab. Arch Ophthalmol. 2012 Sep;130(9):1153-61. doi: 10.1001/archophthalmol.2012.1107.'}, {'pmid': '23807371', 'type': 'BACKGROUND', 'citation': 'Bressler SB, Qin H, Melia M, Bressler NM, Beck RW, Chan CK, Grover S, Miller DG; Diabetic Retinopathy Clinical Research Network. Exploratory analysis of the effect of intravitreal ranibizumab or triamcinolone on worsening of diabetic retinopathy in a randomized clinical trial. JAMA Ophthalmol. 2013 Aug;131(8):1033-40. doi: 10.1001/jamaophthalmol.2013.4154.'}, {'pmid': '23792486', 'type': 'BACKGROUND', 'citation': 'Bressler SB, Almukhtar T, Aiello LP, Bressler NM, Ferris FL 3rd, Glassman AR, Greven CM; Diabetic Retinopathy Clinical Research Network. Green or yellow laser treatment for diabetic macular edema: exploratory assessment within the Diabetic Retinopathy Clinical Research Network. Retina. 2013 Nov-Dec;33(10):2080-8. doi: 10.1097/IAE.0b013e318295f744.'}, {'pmid': '25719991', 'type': 'BACKGROUND', 'citation': 'Bressler SB, Almukhtar T, Bhorade A, Bressler NM, Glassman AR, Huang SS, Jampol LM, Kim JE, Melia M; Diabetic Retinopathy Clinical Research Network Investigators. Repeated intravitreous ranibizumab injections for diabetic macular edema and the risk of sustained elevation of intraocular pressure or the need for ocular hypotensive treatment. JAMA Ophthalmol. 2015 May;133(5):589-97. doi: 10.1001/jamaophthalmol.2015.186.'}, {'pmid': '26035510', 'type': 'BACKGROUND', 'citation': 'Bressler SB, Melia M, Glassman AR, Almukhtar T, Jampol LM, Shami M, Berger BB, Bressler NM; Diabetic Retinopathy Clinical Research Network. RANIBIZUMAB PLUS PROMPT OR DEFERRED LASER FOR DIABETIC MACULAR EDEMA IN EYES WITH VITRECTOMY BEFORE ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR THERAPY. Retina. 2015 Dec;35(12):2516-28. doi: 10.1097/IAE.0000000000000617.'}, {'pmid': '21459214', 'type': 'RESULT', 'citation': 'Elman MJ, Bressler NM, Qin H, Beck RW, Ferris FL 3rd, Friedman SM, Glassman AR, Scott IU, Stockdale CR, Sun JK; Diabetic Retinopathy Clinical Research Network. Expanded 2-year follow-up of ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2011 Apr;118(4):609-14. doi: 10.1016/j.ophtha.2010.12.033.'}, {'pmid': '20427088', 'type': 'RESULT', 'citation': 'Diabetic Retinopathy Clinical Research Network; Elman MJ, Aiello LP, Beck RW, Bressler NM, Bressler SB, Edwards AR, Ferris FL 3rd, Friedman SM, Glassman AR, Miller KM, Scott IU, Stockdale CR, Sun JK. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2010 Jun;117(6):1064-1077.e35. doi: 10.1016/j.ophtha.2010.02.031. Epub 2010 Apr 28.'}, {'pmid': '22999634', 'type': 'RESULT', 'citation': 'Diabetic Retinopathy Clinical Research Network; Elman MJ, Qin H, Aiello LP, Beck RW, Bressler NM, Ferris FL 3rd, Glassman AR, Maturi RK, Melia M. Intravitreal ranibizumab for diabetic macular edema with prompt versus deferred laser treatment: three-year randomized trial results. Ophthalmology. 2012 Nov;119(11):2312-8. doi: 10.1016/j.ophtha.2012.08.022. Epub 2012 Sep 19.'}, {'pmid': '26802783', 'type': 'RESULT', 'citation': 'Bressler SB, Glassman AR, Almukhtar T, Bressler NM, Ferris FL, Googe JM Jr, Gupta SK, Jampol LM, Melia M, Wells JA 3rd; Diabetic Retinopathy Clinical Research Network. Five-Year Outcomes of Ranibizumab With Prompt or Deferred Laser Versus Laser or Triamcinolone Plus Deferred Ranibizumab for Diabetic Macular Edema. Am J Ophthalmol. 2016 Apr;164:57-68. doi: 10.1016/j.ajo.2015.12.025. Epub 2016 Jan 21.'}, {'pmid': '25439614', 'type': 'RESULT', 'citation': 'Elman MJ, Ayala A, Bressler NM, Browning D, Flaxel CJ, Glassman AR, Jampol LM, Stone TW; Diabetic Retinopathy Clinical Research Network. Intravitreal Ranibizumab for diabetic macular edema with prompt versus deferred laser treatment: 5-year randomized trial results. Ophthalmology. 2015 Feb;122(2):375-81. doi: 10.1016/j.ophtha.2014.08.047. Epub 2014 Oct 28.'}, {'pmid': '21571677', 'type': 'DERIVED', 'citation': 'Gangaputra S, Almukhtar T, Glassman AR, Aiello LP, Bressler N, Bressler SB, Danis RP, Davis MD; Diabetic Retinopathy Clinical Research Network. Comparison of film and digital fundus photographs in eyes of individuals with diabetes mellitus. Invest Ophthalmol Vis Sci. 2011 Aug 3;52(9):6168-73. doi: 10.1167/iovs.11-7321.'}, {'pmid': '20008710', 'type': 'DERIVED', 'citation': 'Bhavsar AR, Googe JM Jr, Stockdale CR, Bressler NM, Brucker AJ, Elman MJ, Glassman AR; Diabetic Retinopathy Clinical Research Network. Risk of endophthalmitis after intravitreal drug injection when topical antibiotics are not required: the diabetic retinopathy clinical research network laser-ranibizumab-triamcinolone clinical trials. Arch Ophthalmol. 2009 Dec;127(12):1581-3. doi: 10.1001/archophthalmol.2009.304.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to find out if treatment with an intravitreal injection of triamcinolone or an intravitreal injection of ranibizumab can prevent loss of vision caused by panretinal photocoagulation treatment. At the present time, it is not known whether intravitreal steroid or anti-vascular endothelial growth factor (anti-VEGF) injections are beneficial in preventing vision loss after panretinal photocoagulation (PRP) treatment. It is possible that one or both of the types of injections will prevent vision loss after PRP treatment. However, it is not known whether the benefits of the injections will outweigh the risks. It is possible that because of side effects, the injections may not be as good as laser alone in treating the diabetic retinopathy.', 'detailedDescription': 'Proliferative diabetic retinopathy (PDR) is manifested in retinal neovascularization at the disc (NVD) or elsewhere (NVE). Vitreous hemorrhage or tractional detachment from PDR is a leading cause of severe visual loss and new onset blindness. Without intervention, 60 percent of individuals with diabetic retinopathy will eventually develop PDR, resulting in significant visual loss in nearly fifty percent.\n\nProliferative diabetic retinopathy is currently treated with panretinal photocoagulation (PRP) which destroys areas of the retina but preserves central vision. PRP is most effectively seen in a regression of new vessels, stabilization of the neovascularization, and reduced risk of visual loss. However, the treatment is associated with unavoidable side effects including macular edema with transient or permanent central vision loss, diminished vision loss, and night vision loss. The treatment applies laser burns to the peripheral retinal tissue, destroying outer photoreceptors and retinal pigment epithelium of the retina, and is thought to exert its effect by increasing oxygen delivery to the inner retina and decreasing viable hypoxic cells which are producing growth factors such as VEGF. Studies have implicated vascular endothelial growth factor (VEGF) as the substance leading to neovascularization and/or increased vascular permeability. Thus, it is reasonable to expect that inhibition of VEGF could reduce both PDR and transient vision loss from macular edema. There are several anti-VEGF drugs. Ranibizumab is the drug to be evaluated in this trial. In one trial of ranibizumab on DME, ten patients with chronic DME received a series of 0.5 mg intraocular injections. The treatments were well tolerated with no ocular or systemic adverse events. Since intraocular injections of ranibizumab significantly reduced foveal thickness and improved visual acuity in all ten patients, there is strong rationale to consider this drug as adjunctive therapy to PRP in a attempt to reduce the acute, transient edema that may occur with PRP.\n\nSimilarly, corticosteroids, a class of substances with anti-inflammatory properties, have demonstrated to inhibit the expression of VEGF. Triamcinolone acetonide is often used as a periocular injection for the treatment of cystoid macular edema (CME) secondary to uveitis. Clinically, triamcinolone acetonide is used in the treatment of proliferative vitreoretinopathy and choroidal neovascularization. Studies on patients with proliferative diabetic retinopathy randomly assigned to receive 4 mg triamcinolone 10 to 15 days prior to PRP treatment showed a reduction in central macular thickening, and fluorescein leakage was greater in the injection group than in the control group at 9 and 12 months follow up. Mean visual acuity improved by one line in the injection group and worsened by two lines in the control group.\n\nIn summary, there is strong rationale that using either intravitreal ranibizumab or intravitreal triamcinolone acetonide as an adjunct to PRP could reduce the magnitude of vision loss.\n\nThis study is being conducted to determine whether intravitreal injection of an anti-VEGF drug or an intravitreal injection of a corticosteroid can reduce the occurrence of macular edema and visual acuity impairment following PRP. Subjects will be randomly assigned with equal probability to one of the following three injection groups:\n\n* Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and 4 weeks\n* Intravitreal injection of 4 mg triamcinolone acetonide at baseline and sham injection at 4 weeks\n* Sham injection at baseline and 4 weeks\n\nThe initial injection (or sham) is given on the day of randomization. Focal (macular) photocoagulation is given 7 to 10 days following the injection. Panretinal (scatter) photocoagulation can be initiated either on the same day as the focal photocoagulation (immediately following the focal photocoagulation) or on a subsequent day but must be initiated within 14 days of the baseline injection. Required follow-up visits occur at 4, 14, 34 and 56 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'General Inclusion Criteria\n\n* Age \\>= 18 years\n* Diagnosis of diabetes mellitus (type 1 or type 2)\n* Fellow eye (if not a study eye) meets criteria.\n* Able and willing to provide informed consent. Study Eye Inclusion Criteria Subjects may have one or two study eyes. Subjects with two study eyes will be randomly assigned to receive sham injection at baseline and 4 weeks in one eye and either ranibizumab or triamcinolone in the other eye.\n* Presence of severe nonproliferative or proliferative diabetic retinopathy for which investigator intends to complete panretinal photocoagulation within 49 days after randomization.\n* Diabetic macular edema(DME) present on clinical exam and central subfield thickness on Optical Coherence Tomography (OCT) \\>250 microns, within 8 days of randomization.\n* Best corrected Electronic-Early Treatment Diabetic Retinopathy Study visual acuity letter score \\>=24 (i.e., 20/320 or better), within 8 days of randomization.\n* Media clarity, pupillary dilation, and subject cooperation sufficient to administer panretinal photocoagulation and obtain adequate fundus photographs and OCT.\n* If prior macular photocoagulation has been performed, the investigator believes that the study eye may possibly benefit from additional focal photocoagulation.\n\nGeneral Exclusion Criteria\n\n* Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.\n* A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).\n* Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.\n* Known allergy to any component of the study drugs.\n* Blood pressure \\> 180/110 (systolic above 180 or diastolic above 110).\n* Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months.\n* Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.\n* Systemic anti-vascular endothelial growth factor(VEGF) or pro-VEGF treatment within 4 months prior to randomization.\n* For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.\n* Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the 12 months of the study.\n\nStudy Eye Exclusion Criteria, Study eye only:\n\n* Prior panretinal photocoagulation that was sufficiently extensive that the investigator does not believe that at least 1200 additional burns are needed or possible within 49 days after randomization.\n* Macular edema is considered to be due to a cause other than diabetic macular edema.\n* An ocular condition is present such that, in the opinion of the investigator, preventing visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, non-retinal condition).\n* An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.).\n* Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).\n* History of treatment for DME at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment).\n* History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.\n* History of Yttrium Aluminum Garnet capsulotomy performed within 2 months prior to randomization.\n* Aphakia.\n* Intraocular pressure \\>= 25 mmHg.\n* History of open-angle glaucoma (either primary open-angle glaucoma or other cause of open-angle glaucoma; note: angle-closure glaucoma is not an exclusion criterion).\n* History of steroid-induced intraocular pressure elevation that required intraocular pressure-lowering treatment.\n* History of prior herpetic ocular infection.\n* Exam evidence of ocular toxoplasmosis.\n* Exam evidence of pseudoexfoliation.\n* Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis.\n\nFellow Eye Criteria\n\n* Intraocular pressure \\< 25 mmHg.\n* No history of open-angle glaucoma (either primary open-angle glaucoma or other cause of open-angle glaucoma; note: angle-closure glaucoma is not an exclusion criterion).\n* No history of steroid-induced intraocular pressure elevation that required intraocular pressure-lowering treatment.\n* No exam evidence of pseudoexfoliation.'}, 'identificationModule': {'nctId': 'NCT00445003', 'acronym': 'LRTforDME+PRP', 'briefTitle': 'Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Jaeb Center for Health Research'}, 'officialTitle': 'Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy', 'orgStudyIdInfo': {'id': 'NEI-134'}, 'secondaryIdInfos': [{'id': 'U10EY018817-03', 'link': 'https://reporter.nih.gov/quickSearch/U10EY018817-03', 'type': 'NIH'}, {'id': 'U10EY014229-07', 'link': 'https://reporter.nih.gov/quickSearch/U10EY014229-07', 'type': 'NIH'}, {'id': 'U10EY014231-09', 'link': 'https://reporter.nih.gov/quickSearch/U10EY014231-09', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sham injection plus laser', 'description': 'Sham injection at baseline and 4 weeks. Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups.', 'interventionNames': ['Behavioral: Sham injection', 'Procedure: Focal/grid laser']}, {'type': 'EXPERIMENTAL', 'label': '0.5mg Ranibizumab plus laser', 'description': 'Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks. Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups.', 'interventionNames': ['Drug: Ranibizumab', 'Procedure: Focal/grid laser']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4-mg Triamcinolone Acetonide plus Laser', 'description': '4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks. Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups.', 'interventionNames': ['Drug: Triamcinolone Acetonide', 'Procedure: Focal/grid laser']}], 'interventions': [{'name': 'Ranibizumab', 'type': 'DRUG', 'otherNames': ['Lucentis™'], 'description': 'Intravitreal injection of 0.5 mg ranibizumab at baseline and 4 weeks', 'armGroupLabels': ['0.5mg Ranibizumab plus laser']}, {'name': 'Triamcinolone Acetonide', 'type': 'DRUG', 'otherNames': ['corticosteroid'], 'description': 'Intravitreal injection of 4 mg triamcinolone acetonide at baseline and sham injection at 4 weeks', 'armGroupLabels': ['4-mg Triamcinolone Acetonide plus Laser']}, {'name': 'Sham injection', 'type': 'BEHAVIORAL', 'description': 'Sham injection at baseline and 4 weeks', 'armGroupLabels': ['Sham injection plus laser']}, {'name': 'Focal/grid laser', 'type': 'PROCEDURE', 'description': 'Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups.', 'armGroupLabels': ['0.5mg Ranibizumab plus laser', '4-mg Triamcinolone Acetonide plus Laser', 'Sham injection plus laser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90701', 'city': 'Artesia', 'state': 'California', 'country': 'United States', 'facility': 'Sall Research Medical Center', 'geoPoint': {'lat': 33.86585, 'lon': -118.08312}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Retina-Vitreous Associates Medical Group', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Health Care, Dept. of Ophthalmology', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Desert Retina Consultants, MC', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '93103', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'California Retina Consultants', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Bay Area Retina Associates', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80027', 'city': 'Louisville', 'state': 'Colorado', 'country': 'United States', 'facility': 'Eldorado Retina Associates, P.C.', 'geoPoint': {'lat': 39.97776, 'lon': -105.13193}}, {'zip': '33334', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Vitreous Consultants', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Consultants of Southwest Florida', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33805', 'city': 'Lakeland', 'state': 'Florida', 'country': 'United States', 'facility': 'Central Florida Retina Institute', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Southeast Retina Center, P.C.', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60435', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Retina Associates', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'zip': '46280', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Raj K. Maturi, M.D., P.C.', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '47150', 'city': 'New Albany', 'state': 'Indiana', 'country': 'United States', 'facility': 'John-Kenyon American Eye Institute', 'geoPoint': {'lat': 38.28562, 'lon': -85.82413}}, {'zip': '52002', 'city': 'Dubuque', 'state': 'Iowa', 'country': 'United States', 'facility': 'Medical Associates Clinic, P.C.', 'geoPoint': {'lat': 42.50056, 'lon': -90.66457}}, {'zip': '42001', 'city': 'Paducah', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Paducah Retinal Center', 'geoPoint': {'lat': 37.08339, 'lon': -88.60005}}, {'zip': '04401', 'city': 'Bangor', 'state': 'Maine', 'country': 'United States', 'facility': 'Maine Vitreoretinal Consultants', 'geoPoint': {'lat': 44.79884, 'lon': -68.77265}}, {'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Elman Retina Group, P.A.', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21287-9277', 'city': 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'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '03801', 'city': 'Portsmouth', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Eyesight Ophthalmic Services, PA', 'geoPoint': {'lat': 43.07704, 'lon': -70.75766}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The New York Eye and Ear Infirmary/Faculty Eye Practice', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '13224', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Retina-Vitreous Surgeons of Central New York, PC', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '27599-7040', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina, Dept of Ophthalmology', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Charlotte Eye, Ear, Nose and Throat Assoc., PA', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28211', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Horizon Eye Care, PA', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Eye Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43017', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'OSU Eye Physicians and Surgeons, LLC.', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Retina Northwest, PC', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Casey Eye Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State College of Medicine', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Scheie Eye Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Retina Consultants', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '29169', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Palmetto Retina Center', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '29223', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Retina Center', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '37660', 'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Southeastern Retina Associates, PC', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}, {'zip': '37909', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Southeastern Retina Associates, P.C.', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '79605', 'city': 'Abilene', 'state': 'Texas', 'country': 'United States', 'facility': 'West Texas Retina Consultants P.A.', 'geoPoint': {'lat': 32.44874, 'lon': -99.73314}}, {'zip': '76012', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Retina Associates', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Research Center', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Retina Associates', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77025', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina and Vitreous of Texas', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Vitreoretinal Consultants', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '79424', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Retina Associates', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '78503', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'Valley Retina Institute', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Retinal Consultants of San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '20176', 'city': 'Leesburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Retina Center', 'geoPoint': {'lat': 39.11566, 'lon': -77.5636}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Alexander J. Brucker, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Scheie Eye Institute'}, {'name': 'Joseph Googe, Jr., M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Southeastern Retina Associates, P.C.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jaeb Center for Health Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Eye Institute (NEI)', 'class': 'NIH'}, {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, {'name': 'Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}