Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-04 @ 3:49 PM
Study NCT ID:
NCT06172257
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2023-12-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 401}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2023-12-07', 'studyFirstSubmitQcDate': '2023-12-07', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants with Treatment Emergent Adverse events (TEAEs)', 'timeFrame': 'Up to Week 52', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant. TEAEs are those AEs that occur after administration of the study product and are therefore temporally associated with the use of the study product.'}], 'primaryOutcomes': [{'measure': 'Mean Change from Baseline in BCVA (Best Corrected Visual Acuity)', 'timeFrame': 'Week 52', 'description': 'Assessed using ETDRS (Early Treatment Diabetes Retinopathy Study) letters score: higher numbers on the ETDRS chart representing better visual acuity.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With a 3-line or Greater Gain in BCVA', 'timeFrame': 'Baseline, Week 52', 'description': 'BCVA will be assessed using ETDRS letters score: higher numbers on the ETDRS chart representing better visual acuity.'}, {'measure': 'Mean Change in BCVA', 'timeFrame': 'Baseline, Week 12 and Week 24', 'description': 'BCVA will be assessed using ETDRS letters score: higher numbers on the ETDRS chart representing better visual acuity.'}, {'measure': 'Mean Change in Central Subfield Thickness (CST)', 'timeFrame': 'Baseline, Week 52', 'description': 'CST will be measured by spectral domain optical coherence tomography (SD-OCT)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Topical ophthalmic suspension', 'Eye drop'], 'conditions': ['Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the efficacy and safety of the topical ophthalmic administration of OCS 01 as compared to Vehicle in participants with Diabetic Macular Edema (DME).', 'detailedDescription': 'A Phase 3 Pivotal Double-masked, Randomized, Vehicle-controlled, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in participants with Diabetic Macular Edema'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (selection):\n\n1. Have a signed informed consent form before any study-specific procedures are performed.\n2. Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with CST of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center).\n3. Have a documented diagnosis of Type 1 or Type 2 diabetes mellitus prior to screening (Visit 1).\n\nExclusion Criteria (selection):\n\n1. Have macular edema considered to be because of a cause other than DME.\n2. Have a decrease in BCVA because of causes other than DME.\n3. Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.'}, 'identificationModule': {'nctId': 'NCT06172257', 'briefTitle': 'A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oculis'}, 'officialTitle': 'A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in Subjects With Diabetic Macular Edema', 'orgStudyIdInfo': {'id': 'DX221'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OCS-01', 'description': 'dexamethasone ophthalmic suspension,1.5% \\[15 mg/mL\\]', 'interventionNames': ['Drug: Dexamethasone ophthalmic suspension (OCS-01)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle ophthalmic suspension', 'description': 'Vehicle of OCS-01', 'interventionNames': ['Drug: Vehicle']}], 'interventions': [{'name': 'Dexamethasone ophthalmic suspension (OCS-01)', 'type': 'DRUG', 'otherNames': ['Dexamethasone'], 'description': 'Participants will be dosed with one eye drop of OCS-01 6 times per day for 6 weeks (induction phase) followed by 3 times per day for 46 weeks (maintenance phase).', 'armGroupLabels': ['OCS-01']}, {'name': 'Vehicle', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Participants will be dosed with one eye drop of vehicle 6 times per day for 6 weeks (induction phase) followed by 3 times per day for 46 weeks (maintenance phase).', 'armGroupLabels': ['Vehicle ophthalmic suspension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85297', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Associated Retina Consultants', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Associated Retina Consultants', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85053', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retinal Consultants of Arizona - Phoenix North', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'California Retina Consultants', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Retina Associates of Southern California', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '94303', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Byers Eye Institute', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Retinal Consultants Medical Group, Inc', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95841', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Retinal Consultants Medical Group', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '93103', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'California Retina Consultants', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '90503', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Macula Retina Vitreous Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Retina Specialists of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80503', 'city': 'Longmont', 'state': 'Colorado', 'country': 'United States', 'facility': 'Eye Care Center of Northern Colorado', 'geoPoint': {'lat': 40.16721, 'lon': -105.10193}}, {'zip': '11195', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Sibia Eye Institute', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33761', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Blue Ocean Clinical Research', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33067', 'city': 'Coral Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Research', 'geoPoint': {'lat': 26.27119, 'lon': -80.2706}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Group of Florida', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'East Coast Institute for Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33912', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Consultants of Southwest Florida', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Marietta Eye Clinic', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '30269', 'city': 'Peachtree City', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Retina', 'geoPoint': {'lat': 33.39678, 'lon': -84.59576}}, {'zip': '60304', 'city': 'Oak Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Retina Associates', 'geoPoint': {'lat': 41.88503, 'lon': -87.7845}}, {'zip': '21740', 'city': 'Hagerstown', 'state': 'Maryland', 'country': 'United States', 'facility': 'Cumberland Valley Retina Consultants', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'zip': '21740', 'city': 'Hagerstown', 'state': 'Maryland', 'country': 'United States', 'facility': 'Mid Atlantic Retina Specialists', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '90033', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Mississippi Retina Associates', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Sierra Eye Associates', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '11788', 'city': 'Hauppauge', 'state': 'New York', 'country': 'United States', 'facility': 'VitreoRetinal Consultants of NY', 'geoPoint': {'lat': 40.82565, 'lon': -73.20261}}, {'zip': '11967', 'city': 'Shirley', 'state': 'New York', 'country': 'United States', 'facility': 'Island Retina', 'geoPoint': {'lat': 40.80149, 'lon': -72.8676}}, {'zip': '11590', 'city': 'Westbury', 'state': 'New York', 'country': 'United States', 'facility': 'Vitreoretinal Consultants of NY', 'geoPoint': {'lat': 40.75566, 'lon': -73.58763}}, {'zip': '16507', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Erie Retina Research', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Vision Research Solutions in Philadelphia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29169', 'city': 'West Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Palmetto Retina Center', 'geoPoint': {'lat': 33.99349, 'lon': -81.07398}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Charles Retina Institute', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Retina', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Consultants of Texas', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '76028', 'city': 'Burleson', 'state': 'Texas', 'country': 'United States', 'facility': 'Star Retina', 'geoPoint': {'lat': 32.54208, 'lon': -97.32085}}, {'zip': '77025', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Eye Associates, North Loop', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78681', 'city': 'Round Rock', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Retina Associates', 'geoPoint': {'lat': 30.50826, 'lon': -97.6789}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'San Antonio Eye Center - Downtown Clinic', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Medical Center Ophthalmology Associates', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '75703', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Tyler Retina Consultants', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '24502', 'city': 'Lynchburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Piedmont Eye Center', 'geoPoint': {'lat': 37.41375, 'lon': -79.14225}}, {'zip': '1023', 'city': 'Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Fundacion Zambrano'}, {'zip': 'C1120 AAN', 'city': 'Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Oftalmos - Instituto Oftalmológico de Alta Complejidad'}, {'zip': '1663', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Centro De Ojos Loria Srl'}, {'zip': '1663', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Centro Privado de Ojos'}, {'zip': 'C1015', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Organizacion Medica De Investigacion'}, {'zip': 'C1061AAE', 'city': 'CABA', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Buenos Aires Macula (BAM) Clinical Research'}, {'zip': 'C1008', 'city': 'Ciudad Autónoma de Buenos Aires', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Charles Centro Oftalmológico'}, {'zip': '5000', 'city': 'Córdoba', 'state': 'Córdoba Province', 'country': 'Argentina', 'facility': 'Centro Privado de Ojos Romagosa', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': 'X5016KEH', 'city': 'Córdoba', 'state': 'Córdoba Province', 'country': 'Argentina', 'facility': 'Instituto de Microcirugía Ocular Córdoba (IMOC)', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': 'M5500', 'city': 'Mendoza', 'state': 'Mendoza Province', 'country': 'Argentina', 'facility': 'Oftar Mendoza - Centro Privado de Oftalmología en Mendoza Capital', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'zip': 'A4400', 'city': 'Salta', 'state': 'Salta Province', 'country': 'Argentina', 'facility': 'Centro de la Vision Dr. Kolton', 'geoPoint': {'lat': -24.80645, 'lon': -65.41999}}, {'zip': 'S2000 PRB', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Grupo Laser Vision', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': 'S2000', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Oftalmologìa Global', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '380015', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Rising Retina Clinic', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '560010', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Narayana Nethralaya', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '302004', 'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Agrawal Hospital', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '641014', 'city': 'Coimbatore', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Lotus Eye Hospital and Institute', 'geoPoint': {'lat': 11.00555, 'lon': 76.96612}}, {'zip': '500038', 'city': 'Hyderabad', 'state': 'Telangana', 'country': 'India', 'facility': "St. Theresa's Hospital", 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '208005', 'city': 'Kanpur', 'state': 'Uttar Pradesh', 'country': 'India', 'facility': 'GSVM Medical College', 'geoPoint': {'lat': 26.46523, 'lon': 80.34975}}, {'zip': '00612', 'city': 'Arecibo', 'country': 'Puerto Rico', 'facility': 'Emanuelli Research & Development Center', 'geoPoint': {'lat': 18.47245, 'lon': -66.71573}}], 'overallOfficials': [{'name': 'Diana Do, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford Byers Eye Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oculis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}