Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema (DIAMOND-2)

Study Overview
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Brief Summary
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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
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A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in Subjects with Diabetic Macular Edema

Official Title
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A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in Subjects With Diabetic Macular Edema

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: Dexamethasone ophthalmic suspension (OCS-01)
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (selection): 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 CST of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center). Have a documented diagnosis of Type 1 or Type 2 diabetes mellitus and an HbA1c of ≤ 10.0% prior to screening (Visit 1). Exclusion Criteria (selection): Have macular edema considered to be because of a cause other than DME. Have a decrease in BCVA because of causes other than DME. Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCS-01<br>dexamethasone ophthalmic suspension,1.5% [15 mg/mL] | Drug: Dexamethasone ophthalmic suspension (OCS-01)<br>* 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. Subjects will be dosed with 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).<br>* Other names: Dexamethasone;|
| Placebo Comparator: Vehicle ophthalmic suspension<br>Vehicle of OCS-01 | Drug: Vehicle<br>* The vehicle drug (placebo) eye drops will be dispensed in single dose containers for each subject to have enough medication until the next visit. Subjects will be dosed with eye drop of vehicle 6 times per day for 6 weeks (induction phase) followed by 3 times per day for 46 weeks (maintenance phase).<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in BCVA (Best Corrected Visual Acuity) | Assessed using ETDRS (Early Treatment Diabetes Retinopathy Study) letters score: higher numbers on the EDTRS chart representing better visual acuity | Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eye drop, Topical ophthalmic suspension