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Diabetic Macular EdemaPhase 2/3NCT05066997

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

A Phase 2/3 study testing Dexamethasone ophthalmic suspension (OCS-01) in people with Diabetic Macular Edema, run by Oculis at 52 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Diabetic Macular Edema
What is being tested?
Dexamethasone ophthalmic suspension (OCS-01)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
552 participants
Where
52 sitesin 4 countries
Study dates
19 Oct 2021to 10 Apr 2026
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

52 sites in 4 countries.

52 sites in 4 countries

United States40 sites

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • Retina Consultants of Austin/Austin Research Center for Retina

    Austin, Texas, 78705

  • Retina Consultants of Charleston

    Beaufort, South Carolina, 29902

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Midwest Eye Institute

    Carmel, Indiana, 46290

  • Velocity (Meridian) Clinical Research

    Cincinnati, Ohio, 45202

  • Texas Retina Associates

    Dallas, Texas, 75231

  • Rand Eye Institute

    Deerfield Beach, Florida, 33064

  • Retina Associates

    Elmhurst, Illinois, 60126

  • The Retina Partners

    Encino, California, 91436

  • Verum Research LLC

    Eugene, Oregon, 97401

  • Retina Center of Texas

    Grapevine, Texas, 76051

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • Florida Retina Institute

    Jacksonville, Florida, 32216

  • Charleston Neuroscience Institute

    Ladson, South Carolina, 29456

  • University Retina

    Lemont, Illinois, 60439

  • Retina-Vitreous Surgeons of Central New York

    Liverpool, New York, 13088

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502

  • Valley Retina Institute PA d.b.a. Gulf Coast Eye Institute

    McAllen, Texas, 78503

  • MedEye Associates

    Miami, Florida, 33143

  • Retinal Consultants Medical Group

    Modesto, California, 95356

  • Florida Retina Institute

    Orlando, Florida, 32806

  • Retina Care Specialists

    Palm Beach Gardens, Florida, 33410

  • California Eye Specialists Medical Group

    Pasadena, California, 91107

  • Vision Research Solutions in Philadelphia

    Philadelphia, Pennsylvania, 19141

  • Arizona Retina and Vitreous Consultants

    Phoenix, Arizona, 85016

  • Phoenix Retina Associates

    Phoenix, Arizona, 85050

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota, 57701

  • California Eye Specialists Medical Group

    Redlands, California, 92373

  • Retina Consultants of Southern California

    Redlands, California, 92374

  • Retina Consultants of Minnesota

    Saint Louis Park, Minnesota, 55416

  • California Retina Consultants

    Santa Maria, California, 93454

  • Retina Partners of Northwest Arkansas

    Springdale, Arkansas, 72764

  • The Retina Institute

    St Louis, Missouri, 63128

  • East Florida Eye Institute

    Stuart, Florida, 34994

  • Tyler Retina Consultants

    Tyler, Texas, 75703

  • North Carolina Retina Associates

    Wake Forest, North Carolina, 27587

  • Retina Group Of New England

    Waterford, Connecticut, 06385

  • Strategic Clinical Research Group

    Willow Park, Texas, 76087

Other trials in United States

India6 sites

  • Nethra Eye Hospital

    Bengaluru, Karnataka, 560094

  • L V Prasad Eye Institute

    Bhubaneswar, Odisha, 751024

  • Amrita Institute of Medical Sciences & Research Centre

    Kochi, Kerala, 682041

  • Sarakshi Netralaya

    Nagpur, Maharashtra, 440025

  • ICARE Eye Hospital & Post Graduate Institute

    Noida, Uttar Pradesh, 201301

  • Shivam Retina Clinic and Eye Hospital

    Surat, Gujarat, 395001

Other trials in India

Taiwan4 sites

  • Changhua Christian Hospital

    Changhua, Changhua, 500

  • China Medical University Hospital

    Taichung, Taichung, 40447

  • Taipei Veterans General Hospital

    Taipei, Taipei, 11217

  • Chang Gung Memorial Hospital

    Taoyuan, Taoyuan, 33305

Other trials in Taiwan

Hong Kong2 sites

  • HKU Eye Centre

    Hong Kong

  • Chinese University of Hong Kong Eye Centre

    Kowloon

Other trials in Hong Kong

About this study

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

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).

Read the detailed description

A Phase 2/3 Pivotal Double-masked, Randomized, Vehicle-controlled, 2 stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Participants with Diabetic Macular Edema

Stage 1: To select a dose and dosing regimen for OCS-01 in participants with DME and evaluate the efficacy and safety of OCS-01 as compared to Vehicle in participants with DME.

Stage 2: To evaluate the efficacy and safety of OCS-01 as compared to Vehicle at Week 52 in participants with DME.

Being tested
Dexamethasone ophthalmic suspension (OCS-01), Vehicle
Keywords
Topical ophthalmic suspension, Eye drop

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexamethasone ophthalmic suspension (OCS-01)Drug

    Also called Dexamethasone

    Stage 1: 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 6 weeks (maintenance phase).

    Stage 2: 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).

  • VehicleDrug

    Also called Placebo

    Stage 1: 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 6 weeks (maintenance phase).

    Stage 2: Participant 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).

Study groups in NCT05066997
Study groupRoleWhat they receive
OCS-01Experimentaldexamethasone ophthalmic suspension,1.5% [15 mg/ mL]
Receives: Drug: Dexamethasone ophthalmic suspension (OCS-01)
Vehicle VehiclePlacebo comparatorPlacebo is a Vehicle ophthalmic suspension of OCS-01
Receives: Drug: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change in BCVA (Best Corrected Visual Acuity)

    Assessed using ETDRS (Early Treatment Diabetes Retinopathy Study) letters score: higher numbers on the ETDRS chart representing better visual acuity

    Measured: Week 52

Secondary outcomes (3)

  1. Percentage of Participants with a 3-line or Greater Gain in BCVA

    BCVA will be assessed by ETDRS letters score: higher numbers on the ETDRS chart representing better visual acuity.

    Measured: Baseline, Week 52

  2. Mean Change in BCVA

    BCVA will be assessed using ETDRS letters score: higher numbers on the ETDRS chart representing better visual acuity.

    Measured: Baseline, Week 12 and Week 24

  3. Mean Change in Central Subfield Thickness (CST)

    CST will be measured by SD-OCT.

    Measured: Baseline, Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2021
  2. Study start19 Oct 2021
  3. Primary completion10 Apr 2026
  4. Study completion10 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
552 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05066997
Sponsor's protocol ID
DX219
Status last verified
Apr 2026
First submitted
2 Sep 2021
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Khanani AM, Tadayoni R, Markabi S, Patel S, Salehi-Had H, Boyer DS. Safety and efficacy of topical OCS-01 ophthalmic suspension for the treatment of diabetic macular oedema: stage 1 of a multicentre, double-blind, randomised, vehicle-controlled phase 2/3 trial. EClinicalMedicine. 2026 Jul 27;98:104091. doi: 10.1016/j.eclinm.2026.104091. eCollection 2026 Aug.

    PubMed 42564608

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Dexamethasone ophthalmic suspension (OCS-01) in people with Diabetic Macular Edema, run by Oculis at 52 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, India, Taiwan, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in BCVA (Best Corrected Visual Acuity) (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05066997, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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