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Eye drops could replace needles for diabetic eye swelling

NCT ID NCT05066997

Disease control Sponsor: Oculis Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested OCS-01, a steroid eye drop, in 552 people with diabetic macular edema (DME), a condition where fluid builds up in the eye and blurs vision. Participants used the drops several times daily for up to a year. The goal was to see if the drops improve vision and reduce swelling compared to a placebo. If effective, this could offer a simpler alternative to current treatments that require eye injections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dexamethasone eye drops (OCS-01)
What this could lead to
If successful, this could provide a convenient, non-invasive eye drop treatment for diabetic macular edema, reducing the need for injections.
What could go wrong
This is a mid-stage trial; results may not confirm lasting benefit. Eye drops require frequent dosing, and side effects like increased eye pressure or cataracts are possible with steroids.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

552 people

The number who actually took part.

Started

Oct 2021

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria (selection) - Stage 1: 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 central subfield thickness (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 at Visit 1 (Screening). Inclusion Criteria (selection) - Stage 2: 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 central subfield thickness (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 Visit 1 (Screening). Exclusion criteria (selection) - Stage 1 and Stage 2: 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.

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Conditions

The condition(s) this trial relates to.

diabetic macular edema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic macular edema

Contacts and locations

Locations

  • Amrita Institute of Medical Sciences & Research Centre

    Kochi, Kerala, 682041, India

  • Arizona Retina and Vitreous Consultants

    Phoenix, Arizona, 85016, United States

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota, 57701, United States

  • California Eye Specialists Medical Group

    Pasadena, California, 91107, United States

  • California Eye Specialists Medical Group

    Redlands, California, 92373, United States

  • California Retina Consultants

    Santa Maria, California, 93454, United States

  • Chang Gung Memorial Hospital

    Taoyuan, Taoyuan, 33305, Taiwan

  • Changhua Christian Hospital

    Changhua, Changhua, 500, Taiwan

  • Charleston Neuroscience Institute

    Ladson, South Carolina, 29456, United States

  • China Medical University Hospital

    Taichung, Taichung, 40447, Taiwan

  • Chinese University of Hong Kong Eye Centre

    Kowloon, Hong Kong

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740, United States

  • East Florida Eye Institute

    Stuart, Florida, 34994, United States

  • Florida Retina Institute

    Jacksonville, Florida, 32216, United States

  • Florida Retina Institute

    Orlando, Florida, 32806, United States

  • HKU Eye Centre

    Hong Kong, Hong Kong

  • ICARE Eye Hospital & Post Graduate Institute

    Noida, Uttar Pradesh, 201301, India

  • L V Prasad Eye Institute

    Bhubaneswar, Odisha, 751024, India

  • MedEye Associates

    Miami, Florida, 33143, United States

  • Midwest Eye Institute

    Carmel, Indiana, 46290, United States

  • Nethra Eye Hospital

    Bengaluru, Karnataka, 560094, India

  • North Carolina Retina Associates

    Wake Forest, North Carolina, 27587, United States

  • Phoenix Retina Associates

    Phoenix, Arizona, 85050, United States

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502, United States

  • Rand Eye Institute

    Deerfield Beach, Florida, 33064, United States

  • Retina Associates

    Elmhurst, Illinois, 60126, United States

  • Retina Care Specialists

    Palm Beach Gardens, Florida, 33410, United States

  • Retina Center of Texas

    Grapevine, Texas, 76051, United States

  • Retina Consultants of Austin/Austin Research Center for Retina

    Austin, Texas, 78705, United States

  • Retina Consultants of Charleston

    Beaufort, South Carolina, 29902, United States

  • Retina Consultants of Minnesota

    Saint Louis Park, Minnesota, 55416, United States

  • Retina Consultants of Southern California

    Redlands, California, 92374, United States

  • Retina Group Of New England

    Waterford, Connecticut, 06385, United States

  • Retina Partners of Northwest Arkansas

    Springdale, Arkansas, 72764, United States

  • Retina Research Institute of Texas

    Abilene, Texas, 79606, United States

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211, United States

  • Retina-Vitreous Surgeons of Central New York

    Liverpool, New York, 13088, United States

  • Retinal Consultants Medical Group

    Modesto, California, 95356, United States

  • Sarakshi Netralaya

    Nagpur, Maharashtra, 440025, India

  • Shivam Retina Clinic and Eye Hospital

    Surat, Gujarat, 395001, India

  • Southeast Retina Center

    Augusta, Georgia, 30909, United States

  • Strategic Clinical Research Group

    Willow Park, Texas, 76087, United States

  • Taipei Veterans General Hospital

    Taipei, Taipei, 11217, Taiwan

  • Texas Retina Associates

    Dallas, Texas, 75231, United States

  • The Retina Institute

    St Louis, Missouri, 63128, United States

  • The Retina Partners

    Encino, California, 91436, United States

  • Tyler Retina Consultants

    Tyler, Texas, 75703, United States

  • University Retina

    Lemont, Illinois, 60439, United States

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

    McAllen, Texas, 78503, United States

  • Velocity (Meridian) Clinical Research

    Cincinnati, Ohio, 45202, United States

  • Verum Research LLC

    Eugene, Oregon, 97401, United States

  • Vision Research Solutions in Philadelphia

    Philadelphia, Pennsylvania, 19141, United States

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