CompletedPhase 2/3

A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 1)

United States552 participantsStarted 2021-10-19

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

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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 at Visit 1 (Screening).
✓. 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 prior to Visit 1 (Screening).

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 in BCVA (Best Corrected Visual Acuity)

Timeframe: Week 52

Trial details

NCT IDNCT05066997

SponsorOculis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-10

View on ClinicalTrials.gov More Diabetic Macular Edema trials