Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2026-01-05 @ 5:29 PM
Study NCT ID:
NCT05409235
Status:
COMPLETED
Last Update Posted:
2024-08-09
First Post:
2022-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Nesvategrast (OTT166) in Diabetic Retinopathy (DR)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-05-29', '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': 'sedwards@ocuterratx.com', 'phone': '(339) 234-1333', 'title': 'D. Scott Edwards, Ph.D.', 'organization': 'Chief Development Officer'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '\\[Not specified\\]'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected over 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'OTT166 Cohort 1', 'description': 'Participants received OTT166 5% twice a day for 24 weeks in the study eye', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 36, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'OTT166 Cohort 2', 'description': 'Participants received OTT166 four times a day for 24 weeks in the study eye', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 35, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Vehicle Control Cohort 1', 'description': 'Participants received vehicle control twice a day for 24 weeks in the study eye', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 13, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Vehicle Control Cohort 2', 'description': 'Participants received vehicle control four times a day for 24 weeks in the study eye', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 17, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic retinal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinal neovascularisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Macular oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Accelerated hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cranial nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Macular hole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants Who Improved by ≥ 2 Steps From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OTT166 Cohort 1', 'description': 'Participants received OTT166 5% twice a day for 24 weeks in the study eye'}, {'id': 'OG001', 'title': 'OTT166 Cohort 2', 'description': 'Participants received OTT166 four times a day for 24 weeks in the study eye'}, {'id': 'OG002', 'title': 'Vehicle Control Combined', 'description': 'The combination of the vehicle control twice a day and the vehicle control four times a day groups. Comparisons are made between the two OTT166 dose groups and the combined vehicle control.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.187', 'groupId': 'OG000', 'lowerLimit': '5.557', 'upperLimit': '18.816'}, {'value': '12.263', 'groupId': 'OG001', 'lowerLimit': '5.297', 'upperLimit': '19.229'}, {'value': '13.311', 'groupId': 'OG002', 'lowerLimit': '6.260', 'upperLimit': '20.361'}]}]}], 'analyses': [{'pValue': '0.5730', 'groupIds': ['OG000', 'OG002'], 'paramType': 'difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.064', 'ciLowerLimit': '-10.578', 'ciUpperLimit': '8.449', 'estimateComment': 'A single imputation (non-response) when applying composite variable strategy. MI based for missing data at Week 24, assuming MAR when applying hypothetical strategy. Kept in the analysis when applying treatment policy strategy.', 'groupDescription': 'The study was powered to provide a 90% probability to detect a 20% difference between each treatment arm and the combined vehicle control.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MH test is adjusted for the randomization stratification factor (Screening DRSS score 47 or 53 or 61B).'}, {'pValue': '0.5750', 'groupIds': ['OG001', 'OG002'], 'paramType': 'difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.152', 'ciLowerLimit': '-11.178', 'ciUpperLimit': '8.874', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At week 24', 'description': 'To characterize the efficacy of topical OTT166 in participants with DR, the Diabetic Retinopathy Severity Scale (DRSS) was used. The DRSS ranges from 10 to 85 in 12 discrete steps with higher score representing worse DR. The DRSS values were determined by the central reading center. The data reported are the estimated percentage of participants that improved by at least 2 steps from baseline. The reported data include the use of imputation according to the primary estimand as described in the protocol.', 'unitOfMeasure': 'estimated improvement percentage', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized received at least one dose of study drug which is the Intent to Treat (ITT) population for the study. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants That Developed Worse Than Mild PDR (DRSS 65 and Above)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OTT166 Cohort 1', 'description': 'Participants received OTT166 5% twice a day for 24 weeks in the study eye'}, {'id': 'OG001', 'title': 'OTT166 Cohort 2', 'description': 'Participants received OTT166 four times a day for 24 weeks in the study eye'}, {'id': 'OG002', 'title': 'Vehicle Control Combined', 'description': 'The combination of the vehicle control twice a day and the vehicle control four times a day groups. Comparisons are made between the two OTT166 dose groups and the combined vehicle control.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.467', 'groupId': 'OG000', 'lowerLimit': '6.105', 'upperLimit': '18.828'}, {'value': '15.316', 'groupId': 'OG001', 'lowerLimit': '8.158', 'upperLimit': '22.473'}, {'value': '9.405', 'groupId': 'OG002', 'lowerLimit': '3.503', 'upperLimit': '15.307'}]}]}], 'analyses': [{'pValue': '0.7276', 'groupIds': ['OG000', 'OG002'], 'paramType': 'difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '3.119', 'ciLowerLimit': '-5.314', 'ciUpperLimit': '11.592', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8492', 'groupIds': ['OG001', 'OG002'], 'paramType': 'difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '5.779', 'ciLowerLimit': '-3.424', 'ciUpperLimit': '14.982', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At week 24', 'description': 'To determine if topical OTT166 prevented or delayed the occurrence of worse than mild PDR, DRSS of 65 and above. The higher the DRSS, the greater the risk of vision loss and thus the standard of care is to treat affected patients aggressively. The reported data include the use of imputation according to the primary estimand as described in the protocol.', 'unitOfMeasure': 'estimated risk percentage', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Who Developed ASNV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OTT166 Cohort 1', 'description': 'Participants received OTT166 5% twice a day for 24 weeks in the study eye'}, {'id': 'OG001', 'title': 'OTT166 Cohort 2', 'description': 'Participants received OTT166 four times a day for 24 weeks in the study eye'}, {'id': 'OG002', 'title': 'Vehicle Control Combined', 'description': 'The combination of the vehicle control twice a day and the vehicle control four times a day groups. Comparisons are made between the two OTT166 dose groups and the combined vehicle control.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.200', 'groupId': 'OG000', 'lowerLimit': '0.285', 'upperLimit': '8.115'}, {'value': '4.487', 'groupId': 'OG001', 'lowerLimit': '0.288', 'upperLimit': '8.686'}, {'value': '6.068', 'groupId': 'OG002', 'lowerLimit': '1.243', 'upperLimit': '10.892'}]}]}], 'analyses': [{'pValue': '0.3097', 'groupIds': ['OG000', 'OG002'], 'paramType': 'difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.863', 'ciLowerLimit': '-8.036', 'ciUpperLimit': '4.309', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3414', 'groupIds': ['OG001', 'OG002'], 'paramType': 'difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.596', 'ciLowerLimit': '-8.021', 'ciUpperLimit': '4.829', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At week 24', 'description': 'To determine if topical OTT166 prevented or delayed the occurrence of anterior segment neovascularization (ASNV). Measure is the percentage of patients that developed ASNV at 24 weeks. The reported data include the use of imputation according to the primary estimand as described in the protocol.', 'unitOfMeasure': 'estimated risk percentage', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined.'}, {'type': 'SECONDARY', 'title': 'Development of PDR Worse Than Mild (Wtm) (DRSS 65 and Above)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OTT166 Cohort 1', 'description': 'Participants received OTT166 5% twice a day for 24 weeks in the study eye'}, {'id': 'OG001', 'title': 'OTT166 Cohort 2', 'description': 'Participants received OTT166 four times a day for 24 weeks in the study eye'}, {'id': 'OG002', 'title': 'Vehicle Control Combined', 'description': 'The combination of the vehicle control twice a day and the vehicle control four times a day groups. Comparisons are made between the two OTT166 dose groups and the combined vehicle control.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '7.46', 'upperLimit': '20.75'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '10.88', 'upperLimit': '25.82'}, {'value': '16', 'groupId': 'OG002', 'lowerLimit': '10.24', 'upperLimit': '25.35'}]}]}], 'analyses': [{'pValue': '0.397', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.899', 'ciLowerLimit': '0.4378', 'ciUpperLimit': '1.8467', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.605', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.113', 'ciLowerLimit': '0.5596', 'ciUpperLimit': '2.2117', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At week 24', 'description': 'To determine if topical OTT166 prevented or delayed the occurrence of worse than mild PDR (wtmPDR). The determination was made using Kaplan-Meier methodology. The estimated percentage that progressed to wtmPDR by Week 24 is reported. The reported data include the use of imputation according to the primary estimand as described in the protocol.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Who Developed CI-DME', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OTT166 Cohort 1', 'description': 'Participants received OTT166 5% twice a day for 24 weeks in the study eye'}, {'id': 'OG001', 'title': 'OTT166 Cohort 2', 'description': 'Participants received OTT166 four times a day for 24 weeks in the study eye'}, {'id': 'OG002', 'title': 'Vehicle Control Combined', 'description': 'The combination of the vehicle control twice a day and the vehicle control four times a day groups. Comparisons are made between the two OTT166 dose groups and the combined vehicle control.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.827', 'groupId': 'OG000', 'lowerLimit': '7.787', 'upperLimit': '21.867'}, {'value': '20.513', 'groupId': 'OG001', 'lowerLimit': '12.331', 'upperLimit': '28.695'}, {'value': '25.459', 'groupId': 'OG002', 'lowerLimit': '16.581', 'upperLimit': '34.338'}]}]}], 'analyses': [{'pValue': '0.0619', 'groupIds': ['OG000', 'OG002'], 'paramType': 'difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-10.622', 'ciLowerLimit': '-21.972', 'ciUpperLimit': '0.728', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2483', 'groupIds': ['OG001', 'OG002'], 'paramType': 'difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-4.942', 'ciLowerLimit': '-16.897', 'ciUpperLimit': '7.013', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At week 24', 'description': 'To determine if topical OTT166 prevented or delayed the occurrence of CI-DME. CI-DME is defined as the presence of fluid in the central subfield in participants who have no fluid at baseline or CST\\> 325 μm. The reported data include the use of imputation according to the primary estimand as described in the protocol.', 'unitOfMeasure': 'estimated risk percentage', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined.'}, {'type': 'SECONDARY', 'title': 'The Development of CI-DME', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OTT166 Cohort 1', 'description': 'Participants received OTT166 5% twice a day for 24 weeks in the study eye'}, {'id': 'OG001', 'title': 'OTT166 Cohort 2', 'description': 'Participants received OTT166 four times a day for 24 weeks in the study eye'}, {'id': 'OG002', 'title': 'Vehicle Control Combined', 'description': 'The combination of the vehicle control twice a day and the vehicle control four times a day groups. Comparisons are made between the two OTT166 dose groups and the combined vehicle control.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '14.44', 'upperLimit': '30.65'}, {'value': '32', 'groupId': 'OG001', 'lowerLimit': '23.93', 'upperLimit': '42.11'}, {'value': '27', 'groupId': 'OG002', 'lowerLimit': '19.65', 'upperLimit': '37.37'}]}]}], 'analyses': [{'pValue': '0.237', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.807', 'ciLowerLimit': '0.4675', 'ciUpperLimit': '1.3920', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.766', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.279', 'ciLowerLimit': '0.7795', 'ciUpperLimit': '2.0981', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At week 24', 'description': 'To determine if topical OTT166 prevented or delayed the occurrence of CI-DME. CI-DME is defined as the presence of fluid in the central subfield in participants who have no fluid at baseline or CST\\> 325 μm. The reported data include the use of imputation according to the primary estimand as described in the protocol. The percentages of participants that developed CI-DME at Week 24 are reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants That Developed Visually Threatening Complications (VTC) Complications (VTC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OTT166 Cohort 1', 'description': 'Participants received OTT166 5% twice a day for 24 weeks in the study eye'}, {'id': 'OG001', 'title': 'OTT166 Cohort 2', 'description': 'Participants received OTT166 four times a day for 24 weeks in the study eye'}, {'id': 'OG002', 'title': 'Vehicle Control Combined', 'description': 'The combination of the vehicle control twice a day and the vehicle control four times a day groups. Comparisons are made between the two OTT166 dose groups and the combined vehicle control.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.387', 'groupId': 'OG000', 'lowerLimit': '14.990', 'upperLimit': '31.783'}, {'value': '28.829', 'groupId': 'OG001', 'lowerLimit': '19.730', 'upperLimit': '37.928'}, {'value': '29.838', 'groupId': 'OG002', 'lowerLimit': '20.442', 'upperLimit': '39.233'}]}]}], 'analyses': [{'pValue': '0.2022', 'groupIds': ['OG000', 'OG002'], 'paramType': 'difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-6.389', 'ciLowerLimit': '-18.994', 'ciUpperLimit': '6.215', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4476', 'groupIds': ['OG001', 'OG002'], 'paramType': 'difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.043', 'ciLowerLimit': '-14.070', 'ciUpperLimit': '11.984', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 24', 'description': 'To determine if topical OTT166 prevented or delayed the occurrence of a VTC. VTC is defined as the composite outcome of PDR and/or ASNV and/or CI-DME.', 'unitOfMeasure': 'estimated risk percentage', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined.'}, {'type': 'SECONDARY', 'title': 'Time to Development of PDR Worse Than Mild (DRSS 65 and Above) or CI-DME', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OTT166 Cohort 1', 'description': 'Participants received OTT166 5% twice a day for 24 weeks in the study eye'}, {'id': 'OG001', 'title': 'OTT166 Cohort 2', 'description': 'Participants received OTT166 four times a day for 24 weeks in the study eye'}, {'id': 'OG002', 'title': 'Vehicle Control Combined', 'description': 'The combination of the vehicle control twice a day and the vehicle control four times a day groups. Comparisons are made between the two OTT166 dose groups and the combined vehicle control.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'median and 90% confidence interval were not calculable due to an insufficient number of participants having events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'median and 90% confidence interval were not calculable due to an insufficient number of participants having events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'median and 90% confidence interval were not calculable due to an insufficient number of participants having events', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.268', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.843', 'ciLowerLimit': '0.533', 'ciUpperLimit': '1.334', 'pValueComment': 'log-rank test stratified by randomization stratification factor', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.304', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.145', 'ciLowerLimit': '0.738', 'ciUpperLimit': '1.775', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline (Day 1) up to Week 24', 'description': 'To determine if topical OTT166 prevented or delayed the occurrence of PDR worse than mild (DRSS 65 and above) or CI-DME. CI-DME is defined as the presence of fluid in the central subfield in participants who have no fluid at baseline or CST\\> 325 μm. Participants who experienced one or more events (worse than mild PDR and/or CI-DME), the earliest event date was selected. Participants who did not experience either event were censored at the earliest of the last available assessment. Median time to event is reported if calculable.', 'unitOfMeasure': 'median time to event (days)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Change in DRSS Steps at Week 24 Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OTT166 Cohort 1', 'description': 'Participants received OTT166 5% twice a day for 24 weeks in the study eye'}, {'id': 'OG001', 'title': 'OTT166 Cohort 2', 'description': 'Participants received OTT166 four times a day for 24 weeks in the study eye'}, {'id': 'OG002', 'title': 'Vehicle Control Combined', 'description': 'The combination of the vehicle control twice a day and the vehicle control four times a day groups. Comparisons are made between the two OTT166 dose groups and the combined vehicle control.'}], 'classes': [{'title': 'Improved by ≥3 steps', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '6.8', 'groupId': 'OG002'}]}]}, {'title': 'Improved by 2 steps', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '7.9', 'groupId': 'OG001'}, {'value': '4.1', 'groupId': 'OG002'}]}]}, {'title': 'Improved by 1 step', 'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000'}, {'value': '17.1', 'groupId': 'OG001'}, {'value': '27.0', 'groupId': 'OG002'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '44.0', 'groupId': 'OG000'}, {'value': '36.8', 'groupId': 'OG001'}, {'value': '29.7', 'groupId': 'OG002'}]}]}, {'title': 'Worsened by 1 step', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}, {'value': '8.1', 'groupId': 'OG002'}]}]}, {'title': 'Worsened by 2 steps', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'Worsened by ≥3 steps', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}, {'value': '2.7', 'groupId': 'OG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000'}, {'value': '23.7', 'groupId': 'OG001'}, {'value': '20.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.428', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.102', 'ciLowerLimit': '0.4573', 'ciUpperLimit': '2.6570', 'statisticalMethod': 'odds ratio', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor'}, {'pValue': '0.419', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.119', 'ciLowerLimit': '0.4500', 'ciUpperLimit': '2.7846', 'statisticalMethod': 'odds ratio', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor'}], 'paramType': 'NUMBER', 'timeFrame': 'At week 24', 'description': 'To determine the effect of OTT166 on DRSS in participants with moderately severe to severe NPDR and mild PDR treated with topical OTT166. Change in DRSS steps is defined as DR worsening or improving by 1, 2, or ≥ 3 steps along with no change. The reported data include the use of imputation according to the primary estimand as described in the protocol.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Mild PDR at Baseline Who Regressed to NPDR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OTT166 Cohort 1', 'description': 'Participants received OTT166 5% twice a day for 24 weeks in the study eye'}, {'id': 'OG001', 'title': 'OTT166 Cohort 2', 'description': 'Participants received OTT166 four times a day for 24 weeks in the study eye'}, {'id': 'OG002', 'title': 'Vehicle Control Combined', 'description': 'The combination of the vehicle control twice a day and the vehicle control four times a day groups. Comparisons are made between the two OTT166 dose groups and the combined vehicle control.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.533', 'groupId': 'OG000', 'lowerLimit': '0.437', 'upperLimit': '8.629'}, {'value': '2.908', 'groupId': 'OG001', 'lowerLimit': '-0.687', 'upperLimit': '6.502'}, {'value': '6.149', 'groupId': 'OG002', 'lowerLimit': '1.329', 'upperLimit': '10.968'}]}]}], 'analyses': [{'pValue': '0.6716', 'groupIds': ['OG000', 'OG002'], 'paramType': 'difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.544', 'ciLowerLimit': '-7.260', 'ciUpperLimit': '4.172', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8414', 'groupIds': ['OG001', 'OG002'], 'paramType': 'difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-3.412', 'ciLowerLimit': '-9.025', 'ciUpperLimit': '2.200', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At week 24', 'description': 'To determine the effect of OTT166 on DRSS in participants with mild PDR (DRSS 61B) treated with topical OTT166. Regression of disease was defined as decrease in DRSS to 53 or lower. The reported data include the use of imputation according to the primary estimand as described in the protocol.', 'unitOfMeasure': 'estimated improvement percentage', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Best Corrected Visual Acuity (BCVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OTT166 Cohort 1', 'description': 'Participants received OTT166 5% twice a day for 24 weeks in the study eye'}, {'id': 'OG001', 'title': 'OTT166 Cohort 2', 'description': 'Participants received OTT166 four times a day for 24 weeks in the study eye'}, {'id': 'OG002', 'title': 'Vehicle Control Combined', 'description': 'The combination of the vehicle control twice a day and the vehicle control four times a day groups. Comparisons are made between the two OTT166 dose groups and the combined vehicle control.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5829', 'spread': '1.0530', 'groupId': 'OG000'}, {'value': '-2.3353', 'spread': '1.0647', 'groupId': 'OG001'}, {'value': '-0.0504', 'spread': '1.0594', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.647', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.5325', 'ciLowerLimit': '-2.8478', 'ciUpperLimit': '1.7827', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.945', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.2849', 'ciLowerLimit': '-4.6356', 'ciUpperLimit': '0.0658', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline (Day 1) up to Week 24', 'description': 'To determine the effect of OTT166 on BCVA in participants with moderately severe to severe NPDR and mild PDR. BCVA was assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score. A higher score represents better visual function.', 'unitOfMeasure': 'ETDRS letters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Lines Gained/Lost of BCVA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OTT166 Cohort 1', 'description': 'Participants received OTT166 5% twice a day for 24 weeks in the study eye'}, {'id': 'OG001', 'title': 'OTT166 Cohort 2', 'description': 'Participants received OTT166 four times a day for 24 weeks in the study eye'}, {'id': 'OG002', 'title': 'Vehicle Control Combined', 'description': 'The combination of the vehicle control twice a day and the vehicle control four times a day groups. Comparisons are made between the two OTT166 dose groups and the combined vehicle control.'}], 'classes': [{'title': '>=15 letter gain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}]}]}, {'title': '10-14 letter gain', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '4.1', 'groupId': 'OG002'}]}]}, {'title': '5-9 letter gain', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '9.2', 'groupId': 'OG001'}, {'value': '12.2', 'groupId': 'OG002'}]}]}, {'title': '1-4 letter gain', 'categories': [{'measurements': [{'value': '30.7', 'groupId': 'OG000'}, {'value': '30.3', 'groupId': 'OG001'}, {'value': '27.0', 'groupId': 'OG002'}]}]}, {'title': '0 letter loss or gain', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '13.2', 'groupId': 'OG001'}, {'value': '5.4', 'groupId': 'OG002'}]}]}, {'title': '1-4 letter loss', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}, {'value': '13.2', 'groupId': 'OG001'}, {'value': '23.0', 'groupId': 'OG002'}]}]}, {'title': '5-9 letter loss', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '9.2', 'groupId': 'OG001'}, {'value': '8.1', 'groupId': 'OG002'}]}]}, {'title': '10-14 letter loss', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}]}]}, {'title': '>=15 letter loss', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '2.6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000'}, {'value': '18.4', 'groupId': 'OG001'}, {'value': '17.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.367', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.108', 'ciLowerLimit': '0.6722', 'ciUpperLimit': '1.8276', 'statisticalMethod': 'odds ratio', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor'}, {'pValue': '0.857', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.717', 'ciLowerLimit': '0.4295', 'ciUpperLimit': '1.1981', 'statisticalMethod': 'odds ratio', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Odds ratio and p-value are from a proportional odds model with covariates for treatment group and the randomization stratification factor'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline (Day 1) up to Week 24', 'description': 'To determine the effect of OTT166 on BCVA in participants with moderately severe to severe NPDR and mild PDR. Proportion of participants who gained/lost lines of BCVA (± 5, 10, and 15 ETDRS letters) were assessed. The reported data include the use of imputation according to the primary estimand as described in the protocol. 5 ETDRS letters = 1 line.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve for BCVA (ETDRS Letters) From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OTT166 Cohort 1', 'description': 'Participants received OTT166 5% twice a day for 24 weeks in the study eye'}, {'id': 'OG001', 'title': 'OTT166 Cohort 2', 'description': 'Participants received OTT166 four times a day for 24 weeks in the study eye'}, {'id': 'OG002', 'title': 'Vehicle Control Combined', 'description': 'The combination of the vehicle control twice a day and the vehicle control four times a day groups. Comparisons are made between the two OTT166 dose groups and the combined vehicle control.'}], 'classes': [{'categories': [{'measurements': [{'value': '1997.9673', 'spread': '19.3899', 'groupId': 'OG000'}, {'value': '1977.5682', 'spread': '19.1258', 'groupId': 'OG001'}, {'value': '1993.8143', 'spread': '19.4706', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.437', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.1531', 'ciLowerLimit': '-38.7930', 'ciUpperLimit': '47.0991', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.733', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-16.2461', 'ciLowerLimit': '-59.2538', 'ciUpperLimit': '26.7616', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline (Day 1) up to Week 24', 'description': 'To determine the effect of OTT166 on BCVA in participants with moderately severe to severe NPDR and mild PDR. BCVA was assessed by ETDRS letters score. A higher score represents better functioning. AUC from baseline to 24 weeks is calculated by the linear trapezoidal method.', 'unitOfMeasure': 'letters*day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Central Subfield Thickness (CST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OTT166 Cohort 1', 'description': 'Participants received OTT166 5% twice a day for 24 weeks in the study eye'}, {'id': 'OG001', 'title': 'OTT166 Cohort 2', 'description': 'Participants received OTT166 four times a day for 24 weeks in the study eye'}, {'id': 'OG002', 'title': 'Vehicle Control Combined', 'description': 'The combination of the vehicle control twice a day and the vehicle control four times a day groups. Comparisons are made between the two OTT166 dose groups and the combined vehicle control.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.479', 'spread': '4.0974', 'groupId': 'OG000'}, {'value': '9.365', 'spread': '4.1020', 'groupId': 'OG001'}, {'value': '10.416', 'spread': '4.1107', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.770', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.0634', 'ciLowerLimit': '-4.9712', 'ciUpperLimit': '13.0980', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.424', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.0507', 'ciLowerLimit': '-10.1046', 'ciUpperLimit': '8.0032', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline (Day 1) up to Week 24', 'description': 'To determine the effect of OTT166 on CST in participants with moderately severe to severe NPDR and mild PDR. CST was measured by optical coherence tomography (OCT).', 'unitOfMeasure': 'microns', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined.'}, {'type': 'SECONDARY', 'title': 'Area Under The Curve (AUC) for Change From Baseline in CST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OTT166 Cohort 1', 'description': 'Participants received OTT166 5% twice a day for 24 weeks in the study eye'}, {'id': 'OG001', 'title': 'OTT166 Cohort 2', 'description': 'Participants received OTT166 four times a day for 24 weeks in the study eye'}, {'id': 'OG002', 'title': 'Vehicle Control Combined', 'description': 'The combination of the vehicle control twice a day and the vehicle control four times a day groups. Comparisons are made between the two OTT166 dose groups and the combined vehicle control.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.308', 'spread': '0.0568', 'groupId': 'OG000'}, {'value': '6.296', 'spread': '0.0561', 'groupId': 'OG001'}, {'value': '6.287', 'spread': '0.0567', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.606', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.0205', 'ciLowerLimit': '-0.1043', 'ciUpperLimit': '0.1452', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.544', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.0083', 'ciLowerLimit': '-0.1161', 'ciUpperLimit': '0.1326', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From Baseline (Day 1) up to Week 24', 'description': 'To determine the effect of OTT166 on CST in participants with moderately severe to severe NPDR and mild PDR. CST was measured by OCT.', 'unitOfMeasure': 'microns*day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Who Met the Objective Rescue Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OTT166 Cohort 1', 'description': 'Participants received OTT166 5% twice a day for 24 weeks in the study eye'}, {'id': 'OG001', 'title': 'OTT166 Cohort 2', 'description': 'Participants received OTT166 four times a day for 24 weeks in the study eye'}, {'id': 'OG002', 'title': 'Vehicle Control Combined', 'description': 'The combination of the vehicle control twice a day and the vehicle control four times a day groups. Comparisons are made between the two OTT166 dose groups and the combined vehicle control.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.000', 'groupId': 'OG000', 'lowerLimit': '12.752', 'upperLimit': '29.113'}, {'value': '23.684', 'groupId': 'OG001', 'lowerLimit': '15.902', 'upperLimit': '33.071'}, {'value': '21.622', 'groupId': 'OG002', 'lowerLimit': '14.058', 'upperLimit': '30.969'}]}]}], 'analyses': [{'pValue': '0.406', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.544', 'ciLowerLimit': '-12.247', 'ciUpperLimit': '9.158', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.605', 'groupIds': ['OG001', 'OG002'], 'paramType': 'difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.763', 'ciLowerLimit': '-9.114', 'ciUpperLimit': '12.640', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline (Day 1) up to Week 24', 'description': 'To determine the effect of OTT166 on the need for rescue therapy in participants with moderately severe to severe NPDR and mild PDR.', 'unitOfMeasure': 'estimated percentage', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined.'}, {'type': 'SECONDARY', 'title': 'Proportion That Met Objective Rescue Therapy Criteria by Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OTT166 Cohort 1', 'description': 'Participants received OTT166 5% twice a day for 24 weeks in the study eye'}, {'id': 'OG001', 'title': 'OTT166 Cohort 2', 'description': 'Participants received OTT166 four times a day for 24 weeks in the study eye'}, {'id': 'OG002', 'title': 'Vehicle Control Combined', 'description': 'The combination of the vehicle control twice a day and the vehicle control four times a day groups. Comparisons are made between the two OTT166 dose groups and the combined vehicle control.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '12.752', 'upperLimit': '29.113'}, {'value': '26.684', 'groupId': 'OG001', 'lowerLimit': '15.902', 'upperLimit': '33.071'}, {'value': '21.622', 'groupId': 'OG002', 'lowerLimit': '14.058', 'upperLimit': '30.969'}]}]}], 'analyses': [{'pValue': '0.404', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.916', 'ciLowerLimit': '0.5068', 'ciUpperLimit': '1.6556', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.624', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.128', 'ciLowerLimit': '0.6399', 'ciUpperLimit': '1.9868', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline (Day 1) up to Week 24', 'description': 'To determine the effect of OTT166 on the need for rescue therapy in participants with moderately severe to severe NPDR and mild PDR. The reported data include the use of imputation according to the primary estimand as described in the protocol.', 'unitOfMeasure': 'estimated rescue percentage', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined.'}, {'type': 'SECONDARY', 'title': 'Percentages of Participants at Week 24 That Had Had Rescue Therapy Administered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OTT166 Cohort 1', 'description': 'Participants received OTT166 5% twice a day for 24 weeks in the study eye'}, {'id': 'OG001', 'title': 'OTT166 Cohort 2', 'description': 'Participants received OTT166 four times a day for 24 weeks in the study eye'}, {'id': 'OG002', 'title': 'Vehicle Control Combined', 'description': 'The combination of the vehicle control twice a day and the vehicle control four times a day groups. Comparisons are made between the two OTT166 dose groups and the combined vehicle control.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '1.67', 'upperLimit': '10.67'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '2.72', 'upperLimit': '13.33'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '1.71', 'upperLimit': '10.87'}]}]}], 'analyses': [{'pValue': '0.478', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.947', 'ciLowerLimit': '0.2473', 'ciUpperLimit': '3.6295', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Comparisons are made using the log-rank test stratified by randomization stratification factor.'}, {'pValue': '0.631', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.296', 'ciLowerLimit': '0.3688', 'ciUpperLimit': '4.5512', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Comparisons are made using the log-rank test stratified by randomization stratification factor'}], 'paramType': 'NUMBER', 'timeFrame': '24 Weeks', 'description': 'To determine the impact of treatment with OTT166 on the time to receiving rescue therapy. Analysis was performed using the Kaplan-Meier methodology. The reported data include the use of imputation according to the primary estimand as described in the protocol. The data reported are the estimated percentages of participants at Week 24 that had had rescue therapy administered.', 'unitOfMeasure': 'estimated percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Participants That Develop a VTC by Week 24 for DRSS Levels 47 and 53 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OTT166 Cohort 1', 'description': 'Participants received OTT166 5% twice a day for 24 weeks in the study eye'}, {'id': 'OG001', 'title': 'OTT166 Cohort 2', 'description': 'Participants received OTT166 four times a day for 24 weeks in the study eye'}, {'id': 'OG002', 'title': 'Vehicle Control Combined', 'description': 'The combination of the vehicle control twice a day and the vehicle control four times a day groups. Comparisons are made between the two OTT166 dose groups and the combined vehicle control.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.3559', 'groupId': 'OG000', 'lowerLimit': '8.8130', 'upperLimit': '25.8988'}, {'value': '26.9180', 'groupId': 'OG001', 'lowerLimit': '17.0207', 'upperLimit': '36.8154'}, {'value': '30.5254', 'groupId': 'OG002', 'lowerLimit': '19.9191', 'upperLimit': '41.1318'}]}]}], 'analyses': [{'pValue': '0.0450', 'groupIds': ['OG000', 'OG002'], 'paramType': 'difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-13.7727', 'ciLowerLimit': '-27.1319', 'ciUpperLimit': '-0.4134', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3304', 'groupIds': ['OG001', 'OG002'], 'paramType': 'difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-3.8234', 'ciLowerLimit': '-18.1549', 'ciUpperLimit': '10.5081', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'A pre-specified sub group analysis of the NPDR population (DRSS 47 or 53) for the development of a VTC defined as worse than mild PDR, CI-DME or ASNV. The reported data include the use of imputation according to the primary estimand as described in the protocol.', 'unitOfMeasure': 'estimated risk percentage', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Participants Who Developed CI-DME at Week 24 for Randomization Strata DRSS 47 and 53', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OTT166 Cohort 1', 'description': 'Participants received OTT166 5% twice a day for 24 weeks in the study eye'}, {'id': 'OG001', 'title': 'OTT166 Cohort 2', 'description': 'Participants received OTT166 four times a day for 24 weeks in the study eye'}, {'id': 'OG002', 'title': 'Vehicle Control Combined', 'description': 'The combination of the vehicle control twice a day and the vehicle control four times a day groups. Comparisons are made between the two OTT166 dose groups and the combined vehicle control.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.6949', 'groupId': 'OG000', 'lowerLimit': '5.9131', 'upperLimit': '21.4767'}, {'value': '20.8033', 'groupId': 'OG001', 'lowerLimit': '11.7263', 'upperLimit': '29.8803'}, {'value': '28.0508', 'groupId': 'OG002', 'lowerLimit': '17.7603', 'upperLimit': '38.3414'}]}]}], 'analyses': [{'pValue': '0.0275', 'groupIds': ['OG000', 'OG002'], 'paramType': 'difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-14.8877', 'ciLowerLimit': '-27.6462', 'ciUpperLimit': '-2.1293', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1790', 'groupIds': ['OG001', 'OG002'], 'paramType': 'difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-7.5535', 'ciLowerLimit': '-21.0688', 'ciUpperLimit': '5.9617', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'A measure of the ability to prevent CI-DME in participants with NPDR treated with OTT166. The proportion of patients that develop CI-DME (defined as new fluid in patients with no fluid at baseline or CST \\> 325 microns) by week 24. This is a pre-specified sub group analysis and excludes the participants in the DRSS 61B stratum. The reported data include the use of imputation according to the primary estimand as described in the protocol.', 'unitOfMeasure': 'estimated percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population. As was pre-specified in the study protocol, all participants assigned to receive vehicle control are reported as a single Arm/Group, Vehicle Control Combined.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OTT166 Cohort 1', 'description': 'Participants will receive OTT166 low dose for 24 weeks\n\nOTT166: Participants will receive OTT166 5% ophthalmic solution twice a day for 24 weeks'}, {'id': 'FG001', 'title': 'OTT166 Cohort 2', 'description': 'Participants will receive OTT166 high dose for 24 weeks\n\nOTT166: Participants will receive OTT166 5% ophthalmic solution four time a day for 24 weeks'}, {'id': 'FG002', 'title': 'Vehicle Control Cohort 1', 'description': 'Participants will receive vehicle control for 24 weeks\n\nVehicle control: Participants will receive vehicle control twice a day for 24 weeks'}, {'id': 'FG003', 'title': 'Vehicle Control Cohort 2', 'description': 'Participants will receive vehicle control for 24 weeks\n\nVehicle control: Participants will receive vehicle control four times a day for 24 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '76'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '225', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'OTT166 Cohort 1', 'description': 'Participants received OTT166 low dose for 24 weeks\n\nOTT166: Participants received OTT166 5% ophthalmic solution twice a day for 24 weeks'}, {'id': 'BG001', 'title': 'OTT166 Cohort 2', 'description': 'Participants received OTT166 high dose for 24 weeks\n\nOTT166: Participants received OTT166 5% ophthalmic solution four times a day for 24 weeks'}, {'id': 'BG002', 'title': 'Vehicle Control Cohort 1', 'description': 'Participants received vehicle control for 24 weeks\n\nVehicle control: Participants received vehicle control twice a day for 24 weeks'}, {'id': 'BG003', 'title': 'Vehicle Control Cohort 2', 'description': 'Participants received vehicle control for 24 weeks\n\nVehicle control: Participants received vehicle control four times a day for 24 weeks'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '164', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '61', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.7', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '89'}, {'value': '56.8', 'groupId': 'BG001', 'lowerLimit': '35', 'upperLimit': '76'}, {'value': '57.7', 'groupId': 'BG002', 'lowerLimit': '34', 'upperLimit': '87'}, {'value': '53.9', 'groupId': 'BG003', 'lowerLimit': '25', 'upperLimit': '74'}, {'value': '56.4', 'groupId': 'BG004', 'lowerLimit': '24', 'upperLimit': '89'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '95', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '130', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '182', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'Not reported', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '34.1', 'groupId': 'BG000', 'lowerLimit': '21.0', 'upperLimit': '61.5'}, {'value': '33.4', 'groupId': 'BG001', 'lowerLimit': '22.1', 'upperLimit': '62.8'}, {'value': '33.2', 'groupId': 'BG002', 'lowerLimit': '20.4', 'upperLimit': '50.9'}, {'value': '34.1', 'groupId': 'BG003', 'lowerLimit': '22.5', 'upperLimit': '51.5'}, {'value': '34.1', 'groupId': 'BG004', 'lowerLimit': '20.4', 'upperLimit': '62.8'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Hemoglobin a1c', 'classes': [{'categories': [{'measurements': [{'value': '8.56', 'groupId': 'BG000', 'lowerLimit': '5.8', 'upperLimit': '12.0'}, {'value': '8.50', 'groupId': 'BG001', 'lowerLimit': '5.5', 'upperLimit': '12.1'}, {'value': '8.37', 'groupId': 'BG002', 'lowerLimit': '5.9', 'upperLimit': '11.3'}, {'value': '8.64', 'groupId': 'BG003', 'lowerLimit': '5.5', 'upperLimit': '11.1'}, {'value': '8.52', 'groupId': 'BG004', 'lowerLimit': '5.5', 'upperLimit': '12.1'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '% of RBCs with glycosylated hemoglobin', 'dispersionType': 'FULL_RANGE'}, {'title': 'Diabetic retinopathy Severity Scale at Screening', 'classes': [{'title': 'DRSS 47', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '139', 'groupId': 'BG004'}]}]}, {'title': 'DRSS 53', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}]}, {'title': 'DRSS 61B', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': "The Diabetic Retinopathy Severity Scale (DRSS) is a validated 12-level measure of diabetic severity. The study includes only participants' with DRSS 47, 53, or 61B. The scale was used by the imaging core lab to assess the color fundus photographs taken at each visit for the extent of diabetic retinopathy (DR). The scale is based on the counts of abnormalities in seven specified fields of the retinal photographs. The scale ranges from 10 to 85 in discreet steps with the higher number representing more extensive disease. 47 and 53 are moderately severe to severe NPDR and 61B is mild PDR.", 'unitOfMeasure': 'participants'}, {'title': 'Best corrected visual acuity', 'classes': [{'categories': [{'measurements': [{'value': '82.8', 'groupId': 'BG000', 'lowerLimit': '69', 'upperLimit': '94'}, {'value': '82.6', 'groupId': 'BG001', 'lowerLimit': '69', 'upperLimit': '99'}, {'value': '82.9', 'groupId': 'BG002', 'lowerLimit': '69', 'upperLimit': '94'}, {'value': '83.4', 'groupId': 'BG003', 'lowerLimit': '70', 'upperLimit': '99'}, {'value': '82.9', 'groupId': 'BG004', 'lowerLimit': '69', 'upperLimit': '99'}]}]}], 'paramType': 'MEAN', 'description': 'Visual function as measured by best corrected visual acuity (BCVA), the number of letters a participant can read on an Early Treatment for Diabetic Retinopathy Study (ETDRS) eye chart. A higher number of letters reflect better visual acuity with 85 letters equating to 20/20 vision on the commonly used Snellen scale.', 'unitOfMeasure': 'letters', 'dispersionType': 'FULL_RANGE'}, {'title': 'Central subfield thickness (CST)', 'classes': [{'categories': [{'measurements': [{'value': '252.18', 'groupId': 'BG000', 'lowerLimit': '194.7', 'upperLimit': '299.6'}, {'value': '260.72', 'groupId': 'BG001', 'lowerLimit': '185.4', 'upperLimit': '361.1'}, {'value': '262.01', 'groupId': 'BG002', 'lowerLimit': '217.9', 'upperLimit': '324.6'}, {'value': '256.53', 'groupId': 'BG003', 'lowerLimit': '216.2', 'upperLimit': '301.7'}, {'value': '257.42', 'groupId': 'BG004', 'lowerLimit': '185.4', 'upperLimit': '361.1'}]}]}], 'paramType': 'MEAN', 'description': 'The thickness (CST) of the retina in the central subfield (CST) of the fovea as measured by Optical Coherence Tomography (OCT) imaging. The higher CST the more abnormal.', 'unitOfMeasure': 'microns', 'dispersionType': 'FULL_RANGE'}, {'title': 'Duration of Diabetic Retinopathy', 'classes': [{'categories': [{'measurements': [{'value': '1.699', 'groupId': 'BG000', 'lowerLimit': '0.04', 'upperLimit': '16.47'}, {'value': '1.896', 'groupId': 'BG001', 'lowerLimit': '0.04', 'upperLimit': '15.61'}, {'value': '2.667', 'groupId': 'BG002', 'lowerLimit': '0.06', 'upperLimit': '25.37'}, {'value': '1.166', 'groupId': 'BG003', 'lowerLimit': '0.04', 'upperLimit': '7.10'}, {'value': '1.843', 'groupId': 'BG004', 'lowerLimit': '0.04', 'upperLimit': '25.37'}]}]}], 'paramType': 'MEAN', 'description': "The number in years since the participant's diagnosis of DR", 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-10', 'size': 928794, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-26T11:32', 'hasProtocol': True}, {'date': '2024-02-09', 'size': 1110809, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-26T11:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-16', 'studyFirstSubmitDate': '2022-06-03', 'resultsFirstSubmitDate': '2024-04-29', 'studyFirstSubmitQcDate': '2022-06-03', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-16', 'studyFirstPostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Proportion of Participants That Develop a VTC by Week 24 for DRSS Levels 47 and 53 at Baseline', 'timeFrame': '24 weeks', 'description': 'A pre-specified sub group analysis of the NPDR population (DRSS 47 or 53) for the development of a VTC defined as worse than mild PDR, CI-DME or ASNV. The reported data include the use of imputation according to the primary estimand as described in the protocol.'}, {'measure': 'Proportion of Participants Who Developed CI-DME at Week 24 for Randomization Strata DRSS 47 and 53', 'timeFrame': '24 weeks', 'description': 'A measure of the ability to prevent CI-DME in participants with NPDR treated with OTT166. The proportion of patients that develop CI-DME (defined as new fluid in patients with no fluid at baseline or CST \\> 325 microns) by week 24. This is a pre-specified sub group analysis and excludes the participants in the DRSS 61B stratum. The reported data include the use of imputation according to the primary estimand as described in the protocol.'}], 'primaryOutcomes': [{'measure': 'Proportion of Participants Who Improved by ≥ 2 Steps From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Scores', 'timeFrame': 'At week 24', 'description': 'To characterize the efficacy of topical OTT166 in participants with DR, the Diabetic Retinopathy Severity Scale (DRSS) was used. The DRSS ranges from 10 to 85 in 12 discrete steps with higher score representing worse DR. The DRSS values were determined by the central reading center. The data reported are the estimated percentage of participants that improved by at least 2 steps from baseline. The reported data include the use of imputation according to the primary estimand as described in the protocol.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants That Developed Worse Than Mild PDR (DRSS 65 and Above)', 'timeFrame': 'At week 24', 'description': 'To determine if topical OTT166 prevented or delayed the occurrence of worse than mild PDR, DRSS of 65 and above. The higher the DRSS, the greater the risk of vision loss and thus the standard of care is to treat affected patients aggressively. The reported data include the use of imputation according to the primary estimand as described in the protocol.'}, {'measure': 'Proportion of Participants Who Developed ASNV', 'timeFrame': 'At week 24', 'description': 'To determine if topical OTT166 prevented or delayed the occurrence of anterior segment neovascularization (ASNV). Measure is the percentage of patients that developed ASNV at 24 weeks. The reported data include the use of imputation according to the primary estimand as described in the protocol.'}, {'measure': 'Development of PDR Worse Than Mild (Wtm) (DRSS 65 and Above)', 'timeFrame': 'At week 24', 'description': 'To determine if topical OTT166 prevented or delayed the occurrence of worse than mild PDR (wtmPDR). The determination was made using Kaplan-Meier methodology. The estimated percentage that progressed to wtmPDR by Week 24 is reported. The reported data include the use of imputation according to the primary estimand as described in the protocol.'}, {'measure': 'Proportion of Participants Who Developed CI-DME', 'timeFrame': 'At week 24', 'description': 'To determine if topical OTT166 prevented or delayed the occurrence of CI-DME. CI-DME is defined as the presence of fluid in the central subfield in participants who have no fluid at baseline or CST\\> 325 μm. The reported data include the use of imputation according to the primary estimand as described in the protocol.'}, {'measure': 'The Development of CI-DME', 'timeFrame': 'At week 24', 'description': 'To determine if topical OTT166 prevented or delayed the occurrence of CI-DME. CI-DME is defined as the presence of fluid in the central subfield in participants who have no fluid at baseline or CST\\> 325 μm. The reported data include the use of imputation according to the primary estimand as described in the protocol. The percentages of participants that developed CI-DME at Week 24 are reported.'}, {'measure': 'Proportion of Participants That Developed Visually Threatening Complications (VTC) Complications (VTC)', 'timeFrame': 'At Week 24', 'description': 'To determine if topical OTT166 prevented or delayed the occurrence of a VTC. VTC is defined as the composite outcome of PDR and/or ASNV and/or CI-DME.'}, {'measure': 'Time to Development of PDR Worse Than Mild (DRSS 65 and Above) or CI-DME', 'timeFrame': 'From Baseline (Day 1) up to Week 24', 'description': 'To determine if topical OTT166 prevented or delayed the occurrence of PDR worse than mild (DRSS 65 and above) or CI-DME. CI-DME is defined as the presence of fluid in the central subfield in participants who have no fluid at baseline or CST\\> 325 μm. Participants who experienced one or more events (worse than mild PDR and/or CI-DME), the earliest event date was selected. Participants who did not experience either event were censored at the earliest of the last available assessment. Median time to event is reported if calculable.'}, {'measure': 'Proportion of Participants With Change in DRSS Steps at Week 24 Compared to Baseline', 'timeFrame': 'At week 24', 'description': 'To determine the effect of OTT166 on DRSS in participants with moderately severe to severe NPDR and mild PDR treated with topical OTT166. Change in DRSS steps is defined as DR worsening or improving by 1, 2, or ≥ 3 steps along with no change. The reported data include the use of imputation according to the primary estimand as described in the protocol.'}, {'measure': 'Proportion of Participants With Mild PDR at Baseline Who Regressed to NPDR', 'timeFrame': 'At week 24', 'description': 'To determine the effect of OTT166 on DRSS in participants with mild PDR (DRSS 61B) treated with topical OTT166. Regression of disease was defined as decrease in DRSS to 53 or lower. The reported data include the use of imputation according to the primary estimand as described in the protocol.'}, {'measure': 'Change From Baseline in Best Corrected Visual Acuity (BCVA)', 'timeFrame': 'From Baseline (Day 1) up to Week 24', 'description': 'To determine the effect of OTT166 on BCVA in participants with moderately severe to severe NPDR and mild PDR. BCVA was assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score. A higher score represents better visual function.'}, {'measure': 'Proportion of Participants With Lines Gained/Lost of BCVA', 'timeFrame': 'From Baseline (Day 1) up to Week 24', 'description': 'To determine the effect of OTT166 on BCVA in participants with moderately severe to severe NPDR and mild PDR. Proportion of participants who gained/lost lines of BCVA (± 5, 10, and 15 ETDRS letters) were assessed. The reported data include the use of imputation according to the primary estimand as described in the protocol. 5 ETDRS letters = 1 line.'}, {'measure': 'Area Under the Curve for BCVA (ETDRS Letters) From Baseline to Week 24', 'timeFrame': 'From Baseline (Day 1) up to Week 24', 'description': 'To determine the effect of OTT166 on BCVA in participants with moderately severe to severe NPDR and mild PDR. BCVA was assessed by ETDRS letters score. A higher score represents better functioning. AUC from baseline to 24 weeks is calculated by the linear trapezoidal method.'}, {'measure': 'Change From Baseline in Central Subfield Thickness (CST)', 'timeFrame': 'From Baseline (Day 1) up to Week 24', 'description': 'To determine the effect of OTT166 on CST in participants with moderately severe to severe NPDR and mild PDR. CST was measured by optical coherence tomography (OCT).'}, {'measure': 'Area Under The Curve (AUC) for Change From Baseline in CST', 'timeFrame': 'From Baseline (Day 1) up to Week 24', 'description': 'To determine the effect of OTT166 on CST in participants with moderately severe to severe NPDR and mild PDR. CST was measured by OCT.'}, {'measure': 'Proportion of Participants Who Met the Objective Rescue Criteria', 'timeFrame': 'From Baseline (Day 1) up to Week 24', 'description': 'To determine the effect of OTT166 on the need for rescue therapy in participants with moderately severe to severe NPDR and mild PDR.'}, {'measure': 'Proportion That Met Objective Rescue Therapy Criteria by Week 24', 'timeFrame': 'From Baseline (Day 1) up to Week 24', 'description': 'To determine the effect of OTT166 on the need for rescue therapy in participants with moderately severe to severe NPDR and mild PDR. The reported data include the use of imputation according to the primary estimand as described in the protocol.'}, {'measure': 'Percentages of Participants at Week 24 That Had Had Rescue Therapy Administered', 'timeFrame': '24 Weeks', 'description': 'To determine the impact of treatment with OTT166 on the time to receiving rescue therapy. Analysis was performed using the Kaplan-Meier methodology. The reported data include the use of imputation according to the primary estimand as described in the protocol. The data reported are the estimated percentages of participants at Week 24 that had had rescue therapy administered.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetic Retinopathy', 'Ophthalmic solution', 'Non-proliferative diabetic retinopathy', 'Proliferative diabetic retinopathy'], 'conditions': ['Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of OTT166 Ophthalmic solution in participants with Diabetic Retinopathy.', 'detailedDescription': 'This randomized, double-masked, vehicle controlled, phase 2 study will evaluate the safety and efficacy of OTT166 ophthalmic solution in participants with diabetic retinopathy and select an optimum dosing regimen for Phase 3 pivotal trials. Approximately 210 participants diagnosed with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy (PDR) and who are treatment naïve (ie, no prior anti-vascular endothelial growth factor \\[anti-VEGF\\] or laser \\[focal, grid, pan-retinal photocoagulation (PRP)\\] administered) will be randomized 2:2:1:1 into the following groups: OTT166 5% twice daily (BID), OTT166 5% four times daily (QID), vehicle control BID, vehicle control QID. Randomization will be stratified by baseline Diabetic Retinopathy Severity Scale (DRSS) score (47 or 53 or 61B). Participants with PDR (DRSS score 61B) will be capped at 20% of all randomized participants. Each group will self-administer one 50-μl eye drop of study solution (frequency as assigned) for 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Men or women ≥ 18 years of age with type 1 or 2 diabetes mellitus who have moderately severe to severe NPDR \\[DRSS levels 47 or 53\\], or mild PDR \\[DRSS level 61\\] NVE \\< 0.5 DA in 1 + quadrants\\], in whom PRP and/or anti-VEGF IVT can be safely deferred for at least 6 months per the Investigator\n2. BCVA ETDRS letter score in the study eye of ≥ 69 letters (approximate Snellen equivalent of 20/40 or better)\n3. Normal foveal contour\n4. Treatment naïve (ie, no previous anti-VEGF or steroid treatment or PRP or laser)\n5. Willing and able to return for all study visits and comply with study-related procedures\n6. Able to adhere to the study dosing requirements\n7. Understands and signs the written Informed Consent Form\n\nExclusion Criteria:\n\n1. CST of \\> 325 μm\n\n a. Fluid in the central subfield is allowed so long as CST is ≤325 μm and there is a normal foveal contour as determined by the Central Reading Center\n2. Any prior focal or grid laser photocoagulation or any prior PRP in the study eye as it pertains to treatment of DME or DR (peripheral retinal hole treated with laser is allowed)\n3. Eyes with DRSS score 61 with fibrous proliferations at disc or fibrous proliferations elsewhere a. DRSS score 61B with NVE only is allowed. Any sign of fibrosis proliferation is exclusionary\n4. Any prior systemic anti-VEGF treatment or IVT anti-VEGF treatment in the study eye\n5. Any prior intraocular steroid injection in the study eye, inclusive of Iluvien® and Retisert® a. History of Ozurdex® and triamcinolone use prior to 12 months before study enrollment is allowed\n6. Current ASNV, vitreous hemorrhage, or tractional retinal detachment visible at the screening assessments in the study eye\n7. Uncontrolled glaucoma or ocular hypertension in the study eye defined as an IOP \\> 25 mmHg regardless of concomitant treatment with IOP-lowering medications\n8. Hypertension defined as systolic \\> 180 mmHg or \\> 160 mmHg on 2 consecutive measurements (during the same visit) or diastolic \\> 100 mmHg\n9. Screening HbA1c blood test \\> 12.0%\n10. Renal failure (stage 4 or end-stage), dialysis, or history of renal transplant\n11. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the participant at high risk for treatment complications\n12. Initiation of intensive insulin treatment (a pump or multiple daily injections) within 4 months prior to randomization or plans to do so in the next 4 months\n13. Epiretinal membrane, posterior hyaloidal traction, and/or vitreomacular traction in the study eye as determined to be significant by the Investigator\n14. Previous pars plana vitrectomy in the study eye\n15. Any intraocular surgery in the study eye within 90 days (3 months) prior to study enrollment\n16. YAG laser treatment in the study eye within 90 days prior to study enrollment\n17. Concomitant use of any topical ophthalmic medications in the study eye, including dry eye or glaucoma medications, unless on a stable dose for at least 90 days prior to study enrollment and expected to stay on stable dose throughout study participation. Topical eyedrops are allowed but not within ±10 minutes of study drop application\n18. Contact lens use from time of screening throughout the study\n19. Central corneal changes from dry eye that are visually significant and/or Sjogren's syndrome\n20. Visually significant Fuchs endothelial dystrophy or other diagnosed conditions of corneal compromise including Anterior Basement Membrane Dystrophy, or any corneal dystrophy affecting central vision (peripheral processes are not exclusionary)\n21. Chronic or recurrent uveitis in the study eye\n22. Ongoing ocular infection or inflammation in either eye\n23. A history of cataract surgery complicated by vitreous loss in the study eye\n24. Congenital eye malformations in the study eye\n25. A history of penetrating ocular trauma in the study eye\n26. Cognitive impairment that, in the opinion of the investigator, could compromise compliance with the requirements of the study\n27. Females of childbearing potential (ie, who are not postmenopausal for at least 1 year or surgically sterile for at least 6 weeks prior to Visit 1 - Screening/Randomization) who are lactating, or who are pregnant as determined by a positive serum pregnancy test at Visit 1 -Screening/Randomization. Women of childbearing potential must agree to use acceptable methods of birth control throughout the study a. Women who are breastfeeding or who have a positive serum hCG/urine pregnancy test at the screening or BL Visit\n28. Females and males of childbearing potential unwilling or unable to utilize the following acceptable methods of birth control: tubal ligation, transdermal patch, intrauterine devices/systems, oral/implantable/injectable or contraceptives, diaphragm or cervical cap with spermicide, or vasectomized partner for females; condoms with spermicidal agent and vasectomy for males; or sexual abstinence for males and females\n29. Participation in any other investigational device or drug clinical research study within 12 weeks of Visit 1 - Screening/Randomization and during the duration of enrollment\n30. Contraindication to the study medications or fluorescein dye\n31. Other ocular pathologies that, in the investigator's opinion, would interfere with the participant's vision in the study eye\n32. Ocular media of insufficient quality to obtain fundus photographs, fluorescein angiography, and OCT images in the study eye\n33. Concomitant use of Semaglutide (Wegovy®, Ozempic®, Rybelsus®), Thiazolidinediones (Actos®, Avandia®), Liraglutides (Victoza®, Saxenda®), Dulaglutide (Trulicity®), or Tirzepatide (Mounjaro®) within 12 months prior to Visit 1 (allowed if a stable dose has been established for at least 1 year of use) a. Plans to start concomitant use of Semaglutide or Thiazolidinediones during the study duration is exclusionary"}, 'identificationModule': {'nctId': 'NCT05409235', 'briefTitle': 'Nesvategrast (OTT166) in Diabetic Retinopathy (DR)', 'organization': {'class': 'INDUSTRY', 'fullName': 'OcuTerra Therapeutics, Inc.'}, 'officialTitle': 'OTT166-201 A Phase 2 Randomized, Double-Masked, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of OTT166 Ophthalmic Solution in the Treatment of Diabetic Retinopathy (DR)', 'orgStudyIdInfo': {'id': 'OTT166-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OTT166 Cohort 1', 'description': 'Participants will receive OTT166 5% twice a day (BID) for 24 weeks', 'interventionNames': ['Drug: OTT166']}, {'type': 'EXPERIMENTAL', 'label': 'OTT166 Cohort 2', 'description': 'Participants will receive OTT166 5% four times a day (QID) for 24 weeks', 'interventionNames': ['Drug: OTT166']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle control Cohort 1', 'description': 'Participants will receive vehicle control BID for 24 weeks', 'interventionNames': ['Drug: Vehicle control']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle control Cohort 2', 'description': 'Participants will receive vehicle control QID for 24 weeks', 'interventionNames': ['Drug: Vehicle control']}], 'interventions': [{'name': 'OTT166', 'type': 'DRUG', 'otherNames': ['nesvategrast'], 'description': 'Participants will receive OTT166 ophthalmic solution', 'armGroupLabels': ['OTT166 Cohort 1', 'OTT166 Cohort 2']}, {'name': 'Vehicle control', 'type': 'DRUG', 'description': 'Participants will receive vehicle control', 'armGroupLabels': ['Vehicle control Cohort 1', 'Vehicle control Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinical Site 123', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85021', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinical Site 150', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site 111', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site 113', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site 138', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site 129', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site 121', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '91107', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site 127', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '95670', 'city': 'Rancho Cordova', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site 142', 'geoPoint': {'lat': 38.58907, 'lon': -121.30273}}, {'zip': '92505', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site 116', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '95841', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site 125', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'CinCor Site 171', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '94598-5910', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 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{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Clinical Site 104', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Clinical Site 141', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '38671', 'city': 'Southaven', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Clinical Site 155', 'geoPoint': {'lat': 34.98898, 'lon': -90.01259}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Clinical Site 101', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '07003', 'city': 'Bloomfield', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Clinical Site 105', 'geoPoint': {'lat': 40.80677, 'lon': -74.18542}}, {'zip': '08034', 'city': 'Cherry Hill', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Clinical Site 136', 'geoPoint': {'lat': 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