Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2026-01-09 @ 6:13 AM
Study NCT ID:
NCT04265261
Status:
COMPLETED
Last Update Posted:
2024-09-25
First Post:
2020-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic Retinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '1-800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 1 year (baseline through follow-up period)', 'description': 'All-cause mortality includes the entire study population. SAE and NSAE reporting includes the safety population, which included all participants who gave informed consent and received at least one dose of study medication. Participants in the safety population were grouped according to the actual treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received an oral dose of placebo matched to RG7774 once daily (QD)', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 13, 'seriousNumAtRisk': 47, 'deathsNumAffected': 1, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Vicasinabin 30 mg QD', 'description': 'Participants received 30 mg of oral RG7774 QD', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 21, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Vicasinabin 200 mg QD', 'description': 'Participants received 200 mg of oral RG7774 QD', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 44, 'otherNumAffected': 15, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Diabetic retinal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Retinal tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Extradural abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Endometrial hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants With >/= 2-Step Improvement in the Early Treatment Diabetic Retinopathy Study (ETDRS) DR Severity Scale (DRSS) From Baseline at Week 36 Measured in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received an oral dose of placebo matched to RG7774 once daily (QD)'}, {'id': 'OG001', 'title': 'Vicasinabin 30 mg QD', 'description': 'Participants received 30 mg of oral RG7774 QD'}, {'id': 'OG002', 'title': 'Vicasinabin 200 mg QD', 'description': 'Participants received 200 mg of oral RG7774 QD'}], 'classes': [{'categories': [{'measurements': [{'value': '7.89', 'groupId': 'OG000', 'lowerLimit': '2.72', 'upperLimit': '20.8'}, {'value': '9.52', 'groupId': 'OG001', 'lowerLimit': '3.77', 'upperLimit': '22.07'}, {'value': '5.71', 'groupId': 'OG002', 'lowerLimit': '1.58', 'upperLimit': '18.61'}]}]}], 'analyses': [{'pValue': '0.8586', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '-11.86', 'ciUpperLimit': '14.23', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6388', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.93', 'ciLowerLimit': '-15.18', 'ciUpperLimit': '9.31', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 36', 'description': 'The ETDRS DRSS is a standardized grading test to measure diabetic retinopathy progression, where higher scores indicate a higher risk of vision loss. The DRSS ranges from level 10 (no diabetic retinopathy) to level 85 (advanced diabetic retinopathy)', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population is defined as all participants who give informed consent, are randomized, and receive at least one dose of study treatment (active or placebo). For the mITT population, data were analyzed according to the treatment participants were randomized to.'}, {'type': 'SECONDARY', 'title': 'Time-to-Event for Vision-Threatening DR in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received an oral dose of placebo matched to RG7774 once daily (QD)'}, {'id': 'OG001', 'title': 'Vicasinabin 30 mg QD', 'description': 'Participants received 30 mg of oral RG7774 QD'}, {'id': 'OG002', 'title': 'Vicasinabin 200 mg QD', 'description': 'Participants received 200 mg of oral RG7774 QD'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA indicates that either the Kaplan-Meier percentile time has not been achieved or that the percentile is at a boundary of the observed range and no upper or lower 95% CI can be found due to insufficient sample size.', 'groupId': 'OG000', 'lowerLimit': '257.0', 'upperLimit': 'NA'}, {'value': '267.0', 'comment': 'NA indicates that either the Kaplan-Meier percentile time has not been achieved or that the percentile is at a boundary of the observed range and no upper or lower 95% CI can be found due to insufficient sample size..', 'groupId': 'OG001', 'lowerLimit': '254.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA indicates that either the Kaplan-Meier percentile time has not been achieved or that the percentile is at a boundary of the observed range and no upper or lower 95% CI can be found due to insufficient sample size..', 'groupId': 'OG002', 'lowerLimit': '260.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 277', 'description': 'Vision-threatening DR was defined as anterior segment neovascularization (ASNV), new proliferative diabetic retinopathy (PDR), new diabetic macular edema (DME), and pre-existing DME requiring treatment. Time-to-event was defined as the time where 50% of the population develops a DR vision-threatening event.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population is defined as all participants who give informed consent, are randomized, and receive at least one dose of study treatment (active or placebo). For the mITT population, data were analyzed according to the treatment participants were randomized to.'}, {'type': 'SECONDARY', 'title': 'Incidence of New Anterior Segment Neovascularization (ASNV), New Proliferative Diabetic Retinopathy (PDR), New Diabetic Macular Edema (DME), and Pre-Existing DME Requiring Intervention in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received an oral dose of placebo matched to RG7774 once daily (QD)'}, {'id': 'OG001', 'title': 'Vicasinabin 30 mg QD', 'description': 'Participants received 30 mg of oral RG7774 QD'}, {'id': 'OG002', 'title': 'Vicasinabin 200 mg QD', 'description': 'Participants received 200 mg of oral RG7774 QD'}], 'classes': [{'title': 'New ASNV', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '9.4'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '9.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.2'}]}]}, {'title': 'New PDR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '9.4'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '18.2'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.2'}]}]}, {'title': 'New DME', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '9.4'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '15.4'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.2'}]}]}, {'title': 'Pre-existing DME requiring treatment', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '15.7'}, {'value': '10.4', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '23.4'}, {'value': '6.8', 'groupId': 'OG002', 'lowerLimit': '1.8', 'upperLimit': '20.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 36', 'description': 'This is a descriptive summary of the incidence of new ASNV, new PDR, new DME, and pre-existing DME, all of which indicate disease progression. Each row presents the proportion of participants amongst the overall population for each event.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population is defined as all participants who give informed consent, are randomized, and receive at least one dose of study treatment (active or placebo). For the mITT population, data were analyzed according to the treatment participants were randomized to.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received an oral dose of placebo matched to RG7774 once daily (QD)'}, {'id': 'OG001', 'title': 'Vicasinabin 30 mg QD', 'description': 'Participants received 30 mg of oral RG7774 QD'}, {'id': 'OG002', 'title': 'Vicasinabin 200 mg QD', 'description': 'Participants received 200 mg of oral RG7774 QD'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'spread': '0.747', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '0.697', 'groupId': 'OG001'}, {'value': '-0.22', 'spread': '0.744', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 36', 'description': 'BCVA was measured by a qualified VA examiner prior to pupil dilation using modified ETDRS Charts 1, 2, and R. The adjusted mean is reported for each group.', 'unitOfMeasure': 'Number of letters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population is defined as all participants who give informed consent, are randomized, and receive at least one dose of study treatment (active or placebo). For the mITT population, data were analyzed according to the treatment participants were randomized to.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received an oral dose of placebo matched to RG7774 once daily (QD)'}, {'id': 'OG001', 'title': 'Vicasinabin 30 mg QD', 'description': 'Participants received 30 mg of oral RG7774 QD'}, {'id': 'OG002', 'title': 'Vicasinabin 200 mg QD', 'description': 'Participants received 200 mg of oral RG7774 QD'}], 'classes': [{'categories': [{'measurements': [{'value': '72.3', 'groupId': 'OG000'}, {'value': '64.6', 'groupId': 'OG001'}, {'value': '81.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 year (baseline through follow-up period)', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population is defined as all participants who give informed consent, receive at least one dose of study medication (active or placebo) and were grouped according to the actual treatment received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received an oral dose of placebo matched to RG7774 once daily (QD)'}, {'id': 'FG001', 'title': 'Vicasinabin 30 mg QD', 'description': 'Participants received 30 mg of oral RG7774 QD'}, {'id': 'FG002', 'title': 'Vicasinabin 200 mg QD', 'description': 'Participants received 200 mg of oral RG7774 QD'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Non-Compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received an oral dose of placebo matched to RG7774 once daily (QD)'}, {'id': 'BG001', 'title': 'Vicasinabin 30 mg QD', 'description': 'Participants received 30 mg of oral RG7774 QD'}, {'id': 'BG002', 'title': 'Vicasinabin 200 mg QD', 'description': 'Participants received 200 mg of oral RG7774 QD'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.9', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '57.3', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '56.5', 'spread': '10.5', 'groupId': 'BG002'}, {'value': '57.6', 'spread': '9.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-04', 'size': 1103578, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-16T16:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-30', 'studyFirstSubmitDate': '2020-02-05', 'resultsFirstSubmitDate': '2024-07-16', 'studyFirstSubmitQcDate': '2020-02-10', 'lastUpdatePostDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-30', 'studyFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants With >/= 2-Step Improvement in the Early Treatment Diabetic Retinopathy Study (ETDRS) DR Severity Scale (DRSS) From Baseline at Week 36 Measured in the Study Eye', 'timeFrame': 'Week 36', 'description': 'The ETDRS DRSS is a standardized grading test to measure diabetic retinopathy progression, where higher scores indicate a higher risk of vision loss. The DRSS ranges from level 10 (no diabetic retinopathy) to level 85 (advanced diabetic retinopathy)'}, {'measure': 'Percentage of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to 1 year (baseline through follow-up period)'}], 'secondaryOutcomes': [{'measure': 'Time-to-Event for Vision-Threatening DR in the Study Eye', 'timeFrame': 'Up to Day 277', 'description': 'Vision-threatening DR was defined as anterior segment neovascularization (ASNV), new proliferative diabetic retinopathy (PDR), new diabetic macular edema (DME), and pre-existing DME requiring treatment. Time-to-event was defined as the time where 50% of the population develops a DR vision-threatening event.'}, {'measure': 'Incidence of New Anterior Segment Neovascularization (ASNV), New Proliferative Diabetic Retinopathy (PDR), New Diabetic Macular Edema (DME), and Pre-Existing DME Requiring Intervention in the Study Eye', 'timeFrame': 'Week 36', 'description': 'This is a descriptive summary of the incidence of new ASNV, new PDR, new DME, and pre-existing DME, all of which indicate disease progression. Each row presents the proportion of participants amongst the overall population for each event.'}, {'measure': 'Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 36', 'timeFrame': 'Baseline; Week 36', 'description': 'BCVA was measured by a qualified VA examiner prior to pupil dilation using modified ETDRS Charts 1, 2, and R. The adjusted mean is reported for each group.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Retinopathy']}, 'referencesModule': {'references': [{'pmid': '39802207', 'type': 'DERIVED', 'citation': 'Armendariz BG, Luhman UFO, Berger B, Hernandez-Sanchez J, Bogman K, Mitrousis N, Wollenhaupt M, Kent D, Wenzel A, Fauser S. CANBERRA: A Phase II Randomized Clinical Trial to Test the Therapeutic Potential of Oral Vicasinabin in Diabetic Retinopathy. Ophthalmol Sci. 2024 Nov 8;5(2):100650. doi: 10.1016/j.xops.2024.100650. eCollection 2025 Mar-Apr.'}]}, 'descriptionModule': {'briefSummary': "The study's main purpose is to asses the safety, tolerability, and effect of oral administration of RG7774 on the severity of diabetic retinopathy (DR) in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) and good vision."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Able and willing to provide written informed consent and to comply with the study protocol according to International Conference of Harmonization (ICH) and local regulations\n* Male and female patients of at least 18 years of age\n* Treatment naïve with moderately severe to severe NPDR defined as ETDRS DRSS 47 or 53\n* Patients are eligible with and without DME in either eye\n* BCVA score at screening of at least 70 letters in study eyes without DME and at least 75 letters in case DME is present\n* Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images.\n* Diagnosis of diabetes mellitus (DM) type 1 or type 2\n* Hemoglobin A1c (HbA1c) \\</= 12%.\n* A female is eligible to participate if she is not pregnant, not breastfeeding\n\nExclusion Criteria\n\nOcular criteria for study eye:\n\n* Prior treatment for DR or other retinal diseases with any approved or investigational therapy, including but not limited to intravitreal steroids, intravitreal anti-VEGF, light therapy, periocular pharmacological intervention, and laser (e.g. focal, grid, micropulse, or pan-retinal)\n* Uncontrolled glaucoma\n* Any concurrent intraocular condition (e.g. retinal detachment, dense cataract, epiretinal membrane with traction, or vitreomacular traction, etc.) that in the opinion of the Investigator could reduce the potential for improvement, require medical surgical intervention or may confound the visual and functional assessment and interpretation of study results\n\nConcurrent ocular conditions in either eye:\n\n* Any active ocular infection\n* Any active intraocular inflammation\n\nGeneral Criteria:\n\n* Previous systemic use of anti-VEGF drugs within 6 months prior to screening\n* Complications of diabetes such as end-stage renal disease or liver disease\n* Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to screening\n* Uncontrolled blood pressure (\\[BP\\] defined as systolic \\> 180mmHg and/or diastolic \\>100 mmHg while patient at rest)\n* History of concurrent cardio-vascular disease not considered well controlled by the Investigator\n* Any major illness or major surgical procedure within one month before screening\n* History of or currently active other diseases, metabolic dysfunction, physical examination finding, malignancies not considered cured, or clinical laboratory findings giving reasonable suspicion of a condition that contraindicated the use of the investigational medicinal drug or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications in the opinion of the investigator\n* Known hypersensitivity to any of the excipients of the drug used, fluorescein dye or dilating eye drops\n* Use of systemic medications known to be toxic to the lens, retina or optic nerve (e.g., deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines and ethambutol) used during the 6-month period prior to screening or likely need to be used'}, 'identificationModule': {'nctId': 'NCT04265261', 'acronym': 'CANBERRA', 'briefTitle': 'A Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic Retinopathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Double-Masked, 48-Week, Parallel-Group, Placebo-Controlled, Proof-of-Concept Study to Investigate the Efficacy and Safety of RG7774 in Patients With Diabetes Mellitus Type 1 or Type 2 With Treatment-Naive Diabetic Retinopathy', 'orgStudyIdInfo': {'id': 'BP41321'}, 'secondaryIdInfos': [{'id': '2019-002067-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group A', 'description': 'Participants will receive an oral dose of placebo matched to RG7774 once daily (QD)', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Participants will receive a low oral dose of RG7774 QD', 'interventionNames': ['Drug: RG7774']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'description': 'Participants will receive a high oral dose of RG7774 QD', 'interventionNames': ['Drug: RG7774']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive oral placebo matched to RG7774', 'armGroupLabels': ['Group A']}, {'name': 'RG7774', 'type': 'DRUG', 'description': 'Participants will receive oral RG7774', 'armGroupLabels': ['Group B', 'Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Retina and Vitreous Consultants', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retina Associates Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91006', 'city': 'Arcadia', 'state': 'California', 'country': 'United States', 'facility': 'Win Retina', 'geoPoint': {'lat': 34.13973, 'lon': -118.03534}}, {'zip': '91204', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Global Research Management', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Retina Consultants of Southern Colorado PC', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '06385', 'city': 'Waterford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Retina Group of New England', 'geoPoint': {'lat': 41.3417, 'lon': -72.13597}}, {'zip': '33064', 'city': 'Deerfield Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Rand Eye', 'geoPoint': {'lat': 26.31841, 'lon': -80.09977}}, {'zip': '33805', 'city': 'Lakeland', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Retina Consultants', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'zip': '32901', 'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Eye Associates', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Medeye Associates', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32503', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Specialty Institute', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '33711', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Vitreous Assoc of FL', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Southeast Retina Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Marietta Eye Clinic', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '60126', 'city': 'Elmhurst', 'state': 'Illinois', 'country': 'United States', 'facility': 'Retina Associated Ltd', 'geoPoint': {'lat': 41.89947, 'lon': -87.94034}}, {'zip': '60452', 'city': 'Oak Forest', 'state': 'Illinois', 'country': 'United States', 'facility': 'University Retina and Macula Associates, PC', 'geoPoint': {'lat': 41.60281, 'lon': -87.74394}}, {'zip': '21740', 'city': 'Hagerstown', 'state': 'Maryland', 'country': 'United States', 'facility': 'Cumberland Valley Retina PC', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan, Kellogg Eye Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '38671', 'city': 'Southaven', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Deep Blue Retina PLLC', 'geoPoint': {'lat': 34.98898, 'lon': -90.01259}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Sierra Eye Associates', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '07003', 'city': 'Bloomfield', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Envision Ocular, LLC', 'geoPoint': {'lat': 40.80677, 'lon': -74.18542}}, {'zip': '87109', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Eye Associates of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '13057', 'city': 'East Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Velocity Clinical Research', 'geoPoint': {'lat': 43.06534, 'lon': -76.07853}}, {'zip': '11572', 'city': 'Oceanside', 'state': 'New York', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Long Island', 'geoPoint': {'lat': 40.63871, 'lon': -73.64013}}, {'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Charlotte Eye Ear Nose and Throat Associates', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'EyeHealth Northwest', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '16507', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Erie Retinal Surgery', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': '29456', 'city': 'Ladson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Charleston Neuroscience Institute', 'geoPoint': {'lat': 32.98573, 'lon': -80.10981}}, {'zip': '37421', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Southeastern Retina Associates Chattanooga', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Charles Retina Institute', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '79606', 'city': 'Abilene', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Res Institute of Texas', 'geoPoint': {'lat': 32.44874, 'lon': -99.73314}}, {'zip': '78750', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Clinical Research LLC', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'San Antonio Eye Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77384-4167', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Consultants of Texas', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}, {'zip': '77384', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'Retinal Consultants of Houston', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}, {'zip': '76087', 'city': 'Willow Park', 'state': 'Texas', 'country': 'United States', 'facility': 'Strategic Clinical Research Group, LLC', 'geoPoint': {'lat': 32.76263, 'lon': -97.65058}}, {'zip': '2000', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Sydney Eye Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2000', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Sydney Retina Clinic and Day Surgery', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '3002', 'city': 'East Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Centre For Eye Research Australia', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'zip': '3178', 'city': 'Rowville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Retina Specialists Victoria', 'geoPoint': {'lat': -37.93333, 'lon': 145.23333}}, {'zip': '91-321', 'city': '?ód?', 'country': 'Poland', 'facility': 'Centrum Medyczne Julianow; Zeglarska'}, {'zip': '40-594', 'city': 'Katowice', 'country': 'Poland', 'facility': 'Gabinet Okulistyczny Prof Edward Wylegala', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '31-070', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Centrum Medyczne UNO-MED', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '10-424', 'city': 'Olsztyn', 'country': 'Poland', 'facility': 'Centrum Diagnostyki i Mikrochirurgii Oka LENS', 'geoPoint': {'lat': 53.78376, 'lon': 20.49272}}, {'zip': '44-203', 'city': 'Rybnik', 'country': 'Poland', 'facility': 'LensClinic', 'geoPoint': {'lat': 50.09713, 'lon': 18.54179}}, {'zip': '00612', 'city': 'Arecibo', 'country': 'Puerto Rico', 'facility': 'Emanuelli Research and Development Center LLC', 'geoPoint': {'lat': 18.47245, 'lon': -66.71573}}, {'zip': '974 01', 'city': 'Banská Bystrica', 'country': 'Slovakia', 'facility': 'Fakultna nemocnica s poliklinikou F.D. Roosevelta', 'geoPoint': {'lat': 48.73947, 'lon': 19.14932}}, {'zip': '826 06', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Klinika Oftalmológie LFUK a UNB', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '851 07', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'O?ná klinika UNB a SZU', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '040 11', 'city': 'Košice', 'country': 'Slovakia', 'facility': '3F s.r.o', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'zip': '911 71', 'city': 'Trenčín', 'country': 'Slovakia', 'facility': 'Fakultna nemocnica Trencin', 'geoPoint': {'lat': 48.89452, 'lon': 18.04436}}, {'zip': '012 07', 'city': 'Žilina', 'country': 'Slovakia', 'facility': 'Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie', 'geoPoint': {'lat': 49.22315, 'lon': 18.73941}}, {'zip': '8907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari de Bellvitge; Servicio de Oftalmologia', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '08195', 'city': 'San Cugat Del Valles', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital General de Catalunya'}, {'zip': '28222', 'city': 'Majadahonda', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta de Hierro', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Dos de Maig', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic I Provincial', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '8021', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Clinica Barraquer', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '47012', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'Pio del Rio Hortega University Hospital', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Miguel Servet University Hospital', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'zip': 'BT12 6BA', 'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'Royal Victoria Hospital; Outpatients Department', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'CO4 5JL', 'city': 'Colchester, Essex', 'country': 'United Kingdom', 'facility': 'Colchester General Hospital', 'geoPoint': {'lat': 51.88921, 'lon': 0.90421}}, {'zip': 'GU2 7XX', 'city': 'Guildford', 'country': 'United Kingdom', 'facility': 'Royal Surrey County Hospital; Eye Clinic Research office', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'zip': 'HU3 2JZ', 'city': 'Hull', 'country': 'United Kingdom', 'facility': 'Hull University Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'L7 8XP', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Royal Liverpool University Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'NG7 2UH', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'SR2 9HP', 'city': 'Sunderland', 'country': 'United Kingdom', 'facility': 'Sunderland Eye Infirmary', 'geoPoint': {'lat': 54.90465, 'lon': -1.38222}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\\_and\\_development/who\\_we\\_are\\_how\\_we\\_work/clinical\\_trials/our\\_commitment\\_to\\_data\\_sharing.htm)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}