Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Diabetic Macular Edema
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of OCS-01 ophthalmic suspension versus vehicle alone in subjects with DME
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
This trial is a Phase 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 will confirm the safety and efficacy of OCS-01 versus Vehicle alone in subjects with diabetic macular edema (DME).
Stage 2 will evaluate the efficacy and safety of OCS-01 in subjects with DME.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active treatment arm: OCS-01 In Stage 1: Active treatment arm: OCS-01 - dosing regimen 1 for 6 weeks followed by dosing regimen 2 for 6 weeks. . In Stage 2, subjects will receive the dosing regimen from Stage 1 for OCS-01 for 52 weeks. |
Drug: Active treatment arm: OCS-01 (dexamethasone)
The interventional drug OCS-01 eye drops will be dispensed in single dose containers for each subject to have enough medication until the next visit
Other Names:
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| Placebo Comparator: Vehicle placebo arm In stage 1: Vehicle: dosing regimen 1 for 6 weeks followed by dosing regimen 2 for 6 weeks. In Stage 2, subjects will receive the matched dosing regimen for Vehicle for 52 weeks. |
Drug: Vehicle
The vehicle drug (placebo) eye drops will be dispensed in single dose containers for each subject to have enough medication until the next visit
Other Names:
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Outcome Measures
Primary Outcome Measures
- Mean change in BCVA ETDRS letters (Best Corrected Visual Acuity Early Treatment Diabetic Retinopathy Score [Week 52]
Stage 1: Mean change in BCVA ETDRS letters score compared with baseline. ≤ 65 and ≥ 24: A numerical increase indicates improvement Stage 2: Mean change in BCVA ETDRS letters score at Visit 9 (Week 52) compared with baseline.
Secondary Outcome Measures
- Safety measures [at each visit throughout the study up to week 52]
• Incidence in Treatment Emergent Adverse Events assessed by site
Eligibility Criteria
Criteria
Inclusion Criteria :
-
Have a signed informed consent form before any study-specific procedures are performed;
-
Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (CST) of ≥310 µm (may be adjusted based on gender specific requirements) by SD-OCT at screening (Visit 1) (as assessed by an independent reading center); CST is not part of the eligibility reconfirmation on Day 1
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Have a documented diagnosis of type 1 or type 2 diabetes mellitus and a glycosylated hemoglobin A1c (HbA1c) of ≤ 12.0% (≤108 mmol/mol) at Visit 1 (Screening).
Exclusion criteria:
- Have macular edema considered to be because of a cause other than DME.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oculis Investigative Site | Beverly Hills | California | United States | 90211 |
Sponsors and Collaborators
- Oculis
Investigators
- Principal Investigator: Oculis Investigative Site, Winter Haven, FL
- Principal Investigator: Oculis Investigative Site, Eugene, OR
- Principal Investigator: Oculis Investigative Site, Beverly Hills, CA
- Principal Investigator: Oculis Investigative Site, Hagerstown, MD
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DX219