A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 1)
- Conditions
- Diabetic Macular Edema
- Interventions
- Drug: Vehicle
- Registration Number
- NCT05066997
- Lead Sponsor
- Oculis
- Brief Summary
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).
- Detailed Description
A Phase 2/3 Pivotal Double-masked, Randomized, Vehicle-controlled, 2 stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Participants with Diabetic Macular Edema
Stage 1: To select a dose and dosing regimen for OCS-01 in participants with DME and evaluate the efficacy and safety of OCS-01 as compared to Vehicle in participants with DME.
Stage 2: To evaluate the efficacy and safety of OCS-01 as compared to Vehicle at Week 52 in participants with DME.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 552
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OCS-01 Dexamethasone ophthalmic suspension (OCS-01) dexamethasone ophthalmic suspension,1.5% \[15 mg/ mL\] Vehicle Vehicle Vehicle Placebo is a Vehicle ophthalmic suspension of OCS-01
- Primary Outcome Measures
Name Time Method Mean Change in BCVA (Best Corrected Visual Acuity) Week 52 Assessed using ETDRS (Early Treatment Diabetes Retinopathy Study) letters score: higher numbers on the ETDRS chart representing better visual acuity
- Secondary Outcome Measures
Name Time Method Percentage of Participants with a 3-line or Greater Gain in BCVA Baseline, Week 52 BCVA will be assessed by ETDRS letters score: higher numbers on the ETDRS chart representing better visual acuity.
Mean Change in BCVA Baseline, Week 12 and Week 24 BCVA will be assessed using ETDRS letters score: higher numbers on the ETDRS chart representing better visual acuity.
Mean Change in Central Subfield Thickness (CST) Baseline, Week 52 CST will be measured by SD-OCT.
Trial Locations
- Locations (53)
Arizona Retina and Vitreous Consultants
🇺🇸Phoenix, Arizona, United States
Phoenix Retina Associates
🇺🇸Phoenix, Arizona, United States
Retina Partners of Northwest Arkansas
🇺🇸Springdale, Arkansas, United States
Retina-Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
The Retina Partners
🇺🇸Encino, California, United States
Retinal Consultants Medical Group
🇺🇸Modesto, California, United States
California Eye Specialists Medical Group
🇺🇸Redlands, California, United States
Retina Consultants of Southern California
🇺🇸Redlands, California, United States
California Retina Consultants
🇺🇸Santa Maria, California, United States
Beverly Hills Institute of Ophthalmology
🇺🇸Torrance, California, United States
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