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

ACTIVE_NOT_RECRUITINGPHASE3

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

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

NCT06172257•Oculis

View on ClinicalTrials.gov

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).

Detailed Description

A Phase 3 Pivotal Double-masked, Randomized, Vehicle-controlled, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in participants with Diabetic Macular Edema

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Have a signed informed consent form before any study-specific procedures are performed.
•2. 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).
•3. Have a documented diagnosis of Type 1 or Type 2 diabetes mellitus prior to screening (Visit 1).

Exclusion Criteria

•1. Have macular edema considered to be because of a cause other than DME.
•2. Have a decrease in BCVA because of causes other than DME.
•3. Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.

Locations (62)

Associated Retina Consultants

Gilbert, Arizona, United States

Associated Retina Consultants

Phoenix, Arizona, United States

Retinal Consultants of Arizona - Phoenix North

Phoenix, Arizona, United States

California Retina Consultants

Bakersfield, California, United States

Retina Associates of Southern California

Huntington Beach, California, United States

Stanford Byers Eye Institute

Palo Alto, California, United States

Retinal Consultants Medical Group, Inc

Sacramento, California, United States

Retinal Consultants Medical Group

Sacramento, California, United States

California Retina Consultants

Santa Barbara, California, United States

Macula Retina Vitreous Center

Torrance, California, United States

Key Dates

Start Date

March 15, 2024

Primary Completion Date

April 1, 2026

Completion Date

April 1, 2026

Last Updated

January 13, 2026

Enrollment

401

ACTUAL participants

Conditions

Diabetic Macular Edema

Interventions

Dexamethasone ophthalmic suspension (OCS-01)

DRUG

Vehicle

DRUG

COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

NCT07449936

Diabetic Macular EdemaDME+1 more

View study

RECRUITINGPHASE3

CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

NCT07449923

Diabetic Macular EdemaDME+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

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