CompletedPhase 3

A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2)

United States401 participantsStarted 2024-03-15

Plain-language 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).

Who can participate

Age range18 Years – 85 Years

SexALL

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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 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 prior to screening (Visit 1).

Exclusion criteria

✕. 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.

What they're measuring

Mean Change from Baseline in BCVA (Best Corrected Visual Acuity)

Timeframe: Week 52

Trial details

NCT IDNCT06172257

SponsorOculis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-02

View on ClinicalTrials.gov More Diabetic Macular Edema trials