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Eye drops could replace needles for Diabetes-Related vision loss

NCT ID NCT06172257

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a steroid eye drop called OCS 01 can improve vision in people with diabetic macular edema, a common cause of vision loss in diabetes. Over 400 participants used the drops several times daily for a year. The goal was to see if this non-invasive treatment could match or beat current injection therapies.

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 it works, this could offer a simple eye drop alternative to eye injections for controlling diabetic macular edema and improving vision.
What could go wrong
This is a completed Phase 3 trial, but results are not yet public. Eye drops may be less effective than injections, 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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

401 people

The number who actually took part.

Started

Mar 2024

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): 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.

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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

  • Advanced Research

    Coral Springs, Florida, 33067, United States

  • Agrawal Hospital

    Jaipur, Rajasthan, 302004, India

  • Associated Retina Consultants

    Gilbert, Arizona, 85297, United States

  • Associated Retina Consultants

    Phoenix, Arizona, 85020, United States

  • Austin Retina Associates

    Round Rock, Texas, 78681, United States

  • Blue Ocean Clinical Research

    Clearwater, Florida, 33761, United States

  • Buenos Aires Macula (BAM) Clinical Research

    CABA, Buenos Aires, C1061AAE, Argentina

  • California Retina Consultants

    Bakersfield, California, 93309, United States

  • California Retina Consultants

    Santa Barbara, California, 93103, United States

  • Centro De Ojos Loria Srl

    CABA, Buenos Aires, 1663, Argentina

  • Centro Privado de Ojos

    CABA, Buenos Aires, 1663, Argentina

  • Centro Privado de Ojos Romagosa

    Córdoba, Córdoba Province, 5000, Argentina

  • Centro de la Vision Dr. Kolton

    Salta, Salta Province, A4400, Argentina

  • Charles Centro Oftalmológico

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1008, Argentina

  • Charles Retina Institute

    Germantown, Tennessee, 38138, United States

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740, United States

  • East Coast Institute for Research

    Jacksonville, Florida, 32256, United States

  • Emanuelli Research & Development Center

    Arecibo, 00612, Puerto Rico

  • Erie Retina Research

    Erie, Pennsylvania, 16507, United States

  • Eye Care Center of Northern Colorado

    Longmont, Colorado, 80503, United States

  • Fundacion Zambrano

    Buenos Aires, Buenos Aires, 1023, Argentina

  • GSVM Medical College

    Kanpur, Uttar Pradesh, 208005, India

  • Georgia Retina

    Peachtree City, Georgia, 30269, United States

  • Grupo Laser Vision

    Rosario, Santa Fe Province, S2000 PRB, Argentina

  • Houston Eye Associates, North Loop

    Houston, Texas, 77025, United States

  • Illinois Retina Associates

    Oak Park, Illinois, 60304, United States

  • Instituto de Microcirugía Ocular Córdoba (IMOC)

    Córdoba, Córdoba Province, X5016KEH, Argentina

  • Island Retina

    Shirley, New York, 11967, United States

  • Lotus Eye Hospital and Institute

    Coimbatore, Tamil Nadu, 641014, India

  • Macula Retina Vitreous Center

    Torrance, California, 90503, United States

  • Marietta Eye Clinic

    Marietta, Georgia, 30060, United States

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240, United States

  • Mid Atlantic Retina Specialists

    Hagerstown, Maryland, 21740, United States

  • Mississippi Retina Associates

    Jackson, Mississippi, 90033, United States

  • Narayana Nethralaya

    Bangalore, Karnataka, 560010, India

  • Oftalmologìa Global

    Rosario, Santa Fe Province, S2000, Argentina

  • Oftalmos - Instituto Oftalmológico de Alta Complejidad

    Buenos Aires, Buenos Aires, C1120 AAN, Argentina

  • Oftar Mendoza - Centro Privado de Oftalmología en Mendoza Capital

    Mendoza, Mendoza Province, M5500, Argentina

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114, United States

  • Organizacion Medica De Investigacion

    CABA, Buenos Aires, C1015, Argentina

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169, United States

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502, United States

  • Retina Associates of Southern California

    Huntington Beach, California, 92647, United States

  • Retina Consultants of Southwest Florida

    Naples, Florida, 33912, United States

  • Retina Consultants of Texas

    Bellaire, Texas, 77401, United States

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308, United States

  • Retina Specialists of Colorado

    Denver, Colorado, 80210, United States

  • Retinal Consultants Medical Group

    Sacramento, California, 95841, United States

  • Retinal Consultants Medical Group, Inc

    Sacramento, California, 95825, United States

  • Retinal Consultants of Arizona - Phoenix North

    Phoenix, Arizona, 85053, United States

  • Rising Retina Clinic

    Ahmedabad, Gujarat, 380015, India

  • San Antonio Eye Center - Downtown Clinic

    San Antonio, Texas, 78215, United States

  • Sibia Eye Institute

    Boynton Beach, Florida, 11195, United States

  • Sierra Eye Associates

    Reno, Nevada, 89502, United States

  • St. Theresa's Hospital

    Hyderabad, Telangana, 500038, India

  • Stanford Byers Eye Institute

    Palo Alto, California, 94303, United States

  • Star Retina

    Burleson, Texas, 76028, United States

  • Tennessee Retina

    Nashville, Tennessee, 37203, United States

  • Tyler Retina Consultants

    Tyler, Texas, 75703, United States

  • Vision Research Solutions in Philadelphia

    Philadelphia, Pennsylvania, 19141, United States

  • VitreoRetinal Consultants of NY

    Hauppauge, New York, 11788, United States

  • Vitreoretinal Consultants of NY

    Westbury, New York, 11590, United States

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