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

April 30, 2026 updated by: Oculis

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

401

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Buenos Aires, Buenos Aires, Argentina, 1023
        • Fundacion Zambrano
      • Buenos Aires, Buenos Aires, Argentina, C1120 AAN
        • Oftalmos - Instituto Oftalmológico de Alta Complejidad
      • CABA, Buenos Aires, Argentina, 1663
        • Centro De Ojos Loria Srl
      • CABA, Buenos Aires, Argentina, 1663
        • Centro Privado de Ojos
      • CABA, Buenos Aires, Argentina, C1015
        • Organizacion Medica de Investigacion
      • CABA, Buenos Aires, Argentina, C1061AAE
        • Buenos Aires Macula (BAM) Clinical Research
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1008
        • Charles Centro Oftalmológico
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, 5000
        • Centro Privado de Ojos Romagosa
      • Córdoba, Córdoba Province, Argentina, X5016KEH
        • Instituto de Microcirugía Ocular Córdoba (IMOC)
    • Mendoza Province
      • Mendoza, Mendoza Province, Argentina, M5500
        • Oftar Mendoza - Centro Privado de Oftalmología en Mendoza Capital
    • Salta Province
      • Salta, Salta Province, Argentina, A4400
        • Centro de la Vision Dr. Kolton
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000 PRB
        • Grupo Laser Vision
      • Rosario, Santa Fe Province, Argentina, S2000
        • Oftalmologìa Global
  • India
    • Gujarat
      • Ahmedabad, Gujarat, India, 380015
        • Rising Retina Clinic
    • Karnataka
      • Bangalore, Karnataka, India, 560010
        • Narayana Nethralaya
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • Agrawal Hospital
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India, 641014
        • Lotus Eye Hospital and Institute
    • Telangana
      • Hyderabad, Telangana, India, 500038
        • St. Theresa's Hospital
    • Uttar Pradesh
      • Kanpur, Uttar Pradesh, India, 208005
        • Gsvm Medical College
  • Puerto Rico
      • Arecibo, Puerto Rico, 00612
        • Emanuelli Research & Development Center
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Associated Retina Consultants
      • Phoenix, Arizona, United States, 85020
        • Associated Retina Consultants
      • Phoenix, Arizona, United States, 85053
        • Retinal Consultants of Arizona - Phoenix North
    • California
      • Bakersfield, California, United States, 93309
        • California Retina Consultants
      • Huntington Beach, California, United States, 92647
        • Retina Associates of Southern California
      • Palo Alto, California, United States, 94303
        • Stanford Byers Eye Institute
      • Sacramento, California, United States, 95841
        • Retinal Consultants Medical Group
      • Sacramento, California, United States, 95825
        • Retinal Consultants Medical Group, Inc
      • Santa Barbara, California, United States, 93103
        • California Retina Consultants
      • Torrance, California, United States, 90503
        • Macula Retina Vitreous Center
    • Colorado
      • Denver, Colorado, United States, 80210
        • Retina Specialists of Colorado
      • Longmont, Colorado, United States, 80503
        • Eye Care Center of Northern Colorado
    • Florida
      • Boynton Beach, Florida, United States, 11195
        • Sibia Eye Institute
      • Clearwater, Florida, United States, 33761
        • Blue Ocean Clinical Research
      • Coral Springs, Florida, United States, 33067
        • Advanced Research
      • Fort Lauderdale, Florida, United States, 33308
        • Retina Group of Florida
      • Jacksonville, Florida, United States, 32256
        • East Coast Institute for Research
      • Naples, Florida, United States, 33912
        • Retina Consultants of Southwest Florida
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Marietta Eye Clinic
      • Peachtree City, Georgia, United States, 30269
        • Georgia Retina
    • Illinois
      • Oak Park, Illinois, United States, 60304
        • Illinois Retina Associates
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants
      • Hagerstown, Maryland, United States, 21740
        • Mid Atlantic Retina Specialists
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
    • Mississippi
      • Jackson, Mississippi, United States, 90033
        • Mississippi Retina Associates
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New York
      • Hauppauge, New York, United States, 11788
        • Vitreoretinal Consultants of NY
      • Shirley, New York, United States, 11967
        • Island Retina
      • Westbury, New York, United States, 11590
        • Vitreoretinal Consultants of NY
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Erie Retina Research
      • Philadelphia, Pennsylvania, United States, 19141
        • Vision Research Solutions in Philadelphia
    • South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Palmetto Retina Center
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Charles Retina Institute
      • Nashville, Tennessee, United States, 37203
        • Tennessee Retina
    • Texas
      • Bellaire, Texas, United States, 77401
        • Retina Consultants of Texas
      • Burleson, Texas, United States, 76028
        • Star Retina
      • Houston, Texas, United States, 77025
        • Houston Eye Associates, North Loop
      • Round Rock, Texas, United States, 78681
        • Austin Retina Associates
      • San Antonio, Texas, United States, 78240
        • Medical Center Ophthalmology Associates
      • San Antonio, Texas, United States, 78215
        • San Antonio Eye Center - Downtown Clinic
      • Tyler, Texas, United States, 75703
        • Tyler Retina Consultants
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Piedmont Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria (selection):

  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 (selection):

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OCS-01
dexamethasone ophthalmic suspension,1.5% [15 mg/mL]
Drug: Dexamethasone ophthalmic suspension (OCS-01)
Participants will be dosed with one eye drop of OCS-01 6 times per day for 6 weeks (induction phase) followed by 3 times per day for 46 weeks (maintenance phase).
Other Names:
  • Dexamethasone
Placebo Comparator: Vehicle ophthalmic suspension
Vehicle of OCS-01
Drug: Vehicle
Participants will be dosed with one eye drop of vehicle 6 times per day for 6 weeks (induction phase) followed by 3 times per day for 46 weeks (maintenance phase).
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change from Baseline in BCVA (Best Corrected Visual Acuity)
Time Frame: Week 52
Assessed using ETDRS (Early Treatment Diabetes Retinopathy Study) letters score: higher numbers on the ETDRS chart representing better visual acuity.
Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a 3-line or Greater Gain in BCVA
Time Frame: Baseline, Week 52
BCVA will be assessed using ETDRS letters score: higher numbers on the ETDRS chart representing better visual acuity.
Baseline, Week 52
Mean Change in BCVA
Time Frame: Baseline, Week 12 and Week 24
BCVA will be assessed using ETDRS letters score: higher numbers on the ETDRS chart representing better visual acuity.
Baseline, Week 12 and Week 24
Mean Change in Central Subfield Thickness (CST)
Time Frame: Baseline, Week 52
CST will be measured by spectral domain optical coherence tomography (SD-OCT)
Baseline, Week 52

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Treatment Emergent Adverse events (TEAEs)
Time Frame: Up to Week 52
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant. TEAEs are those AEs that occur after administration of the study product and are therefore temporally associated with the use of the study product.
Up to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oculis

Collaborators

ICON plc

Investigators

  • Principal Investigator: Diana Do, MD, Stanford Byers Eye Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2024

Primary Completion (Actual)

April 2, 2026

Study Completion (Actual)

April 2, 2026

Study Registration Dates

First Submitted

December 7, 2023

First Submitted That Met QC Criteria

December 7, 2023

First Posted (Actual)

December 15, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DX221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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