Pivotal Study of OCS-01 Eye Drops in Subjects with Diabetic Macular Edema (DIAMOND-1)
- Conditions
- Diabetic Macular Edema
- Interventions
- Drug: VehicleDrug: Dexamethasone ophthalmic suspension (OCS-01)
- Registration Number
- NCT05066997
- Lead Sponsor
- Oculis
- Brief Summary
The primary objective is to evaluate the efficacy and safety of OCS 01 as compared to Vehicle in subjects with Diabetic Macular Edema (DME).
- Detailed Description
A Phase 2/3 Pivotal Double-masked, Randomized, 2 stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects with Diabetic Macular Edema
Stage 1: To select a dosing regimen for OCS-01 in subjects with DME, and evaluate the efficacy and safety of OCS-01 as compared to Vehicle at Week 12 in subjects with DME.
Stage 2: To evaluate the efficacy and safety of OCS-01 as compared to Vehicle at Week 52 in subjects with DME.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 497
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle placebo arm Vehicle Vehicle ophthalmic suspension OCS-01 Dexamethasone ophthalmic suspension (OCS-01) dexamethasone ophthalmic suspension,1.5% \[15 mg/ mL\]
- Primary Outcome Measures
Name Time Method Mean change in BCVA (Best Corrected Visual Acuity) Stage 1: Week 6; Stage 2: Week 52 Assessed using ETDRS (Early Treatment Diabetes Retinopathy Study) letters score: higher numbers on the EDTRS chart representing better visual acuity
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Oculis Investigative Site: University Retina - Lemont
🇺🇸Lemont, Illinois, United States