Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Diabetic Macular Edema

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of OCS-01 ophthalmic suspension versus vehicle alone in subjects with DME

Detailed Description
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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 (DME). Stage 1: To select a dosing regimen for OCS-01in subjects with DME Stage 2: To confirm the efficacy and safety of the selected dosing regimen of OCS01 in subjects with DME.

Official Title
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A Pivotal, Double-Masked, Randomized, 2-stage, 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: Active treatment arm: OCS-01 (dexamethasone)
* 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 central subfield thickness (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 a glycosylated hemoglobin A1c (HbA1c) of ≤ 12.0% (≤108 mmol/mol) at Visit 1 (Screening). 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 (eg, foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, previous vitreoretinal surgery, central serous retinopathy, nonretinal condition, substantial cataract, macular ischemia). 2) 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: Active treatment arm: OCS-01<br>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 determined from Stage 1 for OCS-01 for 52 weeks. | Drug: Active treatment arm: OCS-01 (dexamethasone)<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<br>* Other names: Dexamethasone;|
| Placebo Comparator: Vehicle placebo arm<br>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<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<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in BCVA (Best Corrected Visual Acuity) ETDRS (Early Treatment Diabetes Retinopathy Study) letters score: higher numbers on the EDTRS chart representing better visual acuity | Stage 1: Mean change in BCVA ETDRS letters score at Visit 5 (Week 6) compared with baseline. Stage 2: Mean change in BCVA ETDRS letters score at Visit 9 (Week 52) compared with baseline. | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measures | • Incidence in Treatment Emergent Adverse Events assessed by site | at each visit throughout the study up to week 52 |