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Completed Phase 2Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05066997

Public ClinicalTrials.gov record NCT05066997. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 4:54 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2/3 Double-Masked, Randomized, 2 Stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT05066997
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2, Phase 3
Lead sponsor
Oculis
Industry
Enrollment
552 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 19, 2021 (Actual)
Primary completion
Apr 10, 2026 (Actual)
Completion
Apr 10, 2026 (Actual)
Last update posted
May 5, 2026

2021 – 2026

United States locations

U.S. sites
40
U.S. states
20
U.S. cities
38
Facility City State ZIP Site status
Arizona Retina and Vitreous Consultants Phoenix Arizona 85016 —
Phoenix Retina Associates Phoenix Arizona 85050 —
Retina Partners of Northwest Arkansas Springdale Arkansas 72764 —
Retina-Vitreous Associates Medical Group Beverly Hills California 90211 —
The Retina Partners Encino California 91436 —
Retinal Consultants Medical Group Modesto California 95356 —
California Eye Specialists Medical Group Pasadena California 91107 —
California Eye Specialists Medical Group Redlands California 92373 —
Retina Consultants of Southern California Redlands California 92374 —
California Retina Consultants Santa Maria California 93454 —
Retina Group Of New England Waterford Connecticut 06385 —
Rand Eye Institute Deerfield Beach Florida 33064 —
Florida Retina Institute Jacksonville Florida 32216 —
MedEye Associates Miami Florida 33143 —
Florida Retina Institute Orlando Florida 32806 —
Retina Care Specialists Palm Beach Gardens Florida 33410 —
East Florida Eye Institute Stuart Florida 34994 —
Southeast Retina Center Augusta Georgia 30909 —
Retina Associates Elmhurst Illinois 60126 —
University Retina Lemont Illinois 60439 —
Midwest Eye Institute Carmel Indiana 46290 —
Cumberland Valley Retina Consultants Hagerstown Maryland 21740 —
Retina Consultants of Minnesota Saint Louis Park Minnesota 55416 —
The Retina Institute St Louis Missouri 63128 —
Retina-Vitreous Surgeons of Central New York Liverpool New York 13088 —
North Carolina Retina Associates Wake Forest North Carolina 27587 —
Velocity (Meridian) Clinical Research Cincinnati Ohio 45202 —
Verum Research LLC Eugene Oregon 97401 —
Vision Research Solutions in Philadelphia Philadelphia Pennsylvania 19141 —
Retina Consultants of Charleston Beaufort South Carolina 29902 —
Charleston Neuroscience Institute Ladson South Carolina 29456 —
Black Hills Regional Eye Institute Rapid City South Dakota 57701 —
Retina Research Institute of Texas Abilene Texas 79606 —
Retina Consultants of Austin/Austin Research Center for Retina Austin Texas 78705 —
Texas Retina Associates Dallas Texas 75231 —
Retina Center of Texas Grapevine Texas 76051 —
Valley Retina Institute PA d.b.a. Gulf Coast Eye Institute McAllen Texas 78503 —
Tyler Retina Consultants Tyler Texas 75703 —
Strategic Clinical Research Group Willow Park Texas 76087 —
Piedmont Eye Center Lynchburg Virginia 24502 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05066997, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 5, 2026 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05066997 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →