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New eye drug could mean fewer shots for Diabetes-Related vision loss

NCT ID NCT07449923

Disease control Sponsor: EyePoint Pharmaceuticals, Inc. 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 6 times

Summary

This study tests a new medicine, EYP-1901, given as an eye injection to people with diabetic macular edema (DME), a condition that causes blurry vision in people with diabetes. The goal is to see if EYP-1901 works as well as the standard treatment (aflibercept) but with fewer injections. About 240 adults with DME will be randomly assigned to receive either EYP-1901 or aflibercept, and their vision will be followed for over a year.

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

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Oct 2028

An estimate. End dates often move.

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 years and older

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: * Previously treated or treatment naïve patients with a documented diagnosis of macular edema associated with diabetic retinopathy (DR) in the study eye, with onset of disease that began at any time prior to the Screening Visit. * Best-corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 35 letters (20/200 Snellen equivalent) to 78 letters (20/32 Snellen equivalent) in the study eye at the Screening Visit and at Baseline (Day 1). * For previously treated participants: at least 1 injection of anti-VEGF in the past 12 months, the most recent anti-VEGF treatment for DME must not have been administered less than 12 weeks prior to the Screening Visit. Exclusion Criteria: * BCVA using ETDRS charts \<30 letters (20/250 Snellen equivalent) in the fellow eye.

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Conditions

The condition(s) this trial relates to.

cystoid macular edema diabetes mellitus diabetic macular edema

As listed by the trial registrant

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

Diabetic macular edema Diabetic macular edema (DME) DME

Contacts and locations

Locations

  • Associated Retina Consultans

    Gilbert, Arizona, 85297, United States

  • Associated Retina Consultants - Phoenix

    Phoenix, Arizona, 85020, United States

  • Associated Vitreoretinal & Uveitis Consultants - Carmel

    Carmel, Indiana, 46032, United States

  • Austin Clinical Research LLC

    Austin, Texas, 78750, United States

  • Axon Clinical, s.r.o.

    Prague, Czechia

  • Bajcsy-Zsilinszky Korhaz es Rendelointezet

    Budapest, Hungary

  • Bay Area Retina Associates

    Walnut Creek, California, 94598, United States

  • Budapest Retina Associates

    Budapest, Hungary

  • Carolinas Centers for Sight, P.C. - Florence Campus

    Florence, South Carolina, 29501, United States

  • Centro Brasileiro de Pesquisa Clinica - Blumenau

    Blumenau, Brazil

  • Charles Retina Institute

    Germantown, Tennessee, 38138, United States

  • Coastal Eye Surgeons, LLC

    Greenwich, Connecticut, 06830, United States

  • Connecticut Eye Consultants, P.C.

    Danbury, Connecticut, 06810, United States

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740, United States

  • Debreceni Egyetem KK Szemklinika

    Debrecen, Hungary

  • EPC-Honvedkorhaz

    Budapest, Hungary

  • Eye Clinic of Wisconsin

    Wausau, Wisconsin, 54403, United States

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, Czechia

  • Fort Lauderdale Eye Institute

    Plantation, Florida, 33324, United States

  • Ganglion Medical Center

    Pécs, Hungary

  • Graystone Eye - Hickory Office

    Hickory, North Carolina, 28602, United States

  • IPEPO - Instituto Paulista de Estudos e Pesquisas em Oftalmologia

    São Paulo, Brazil

  • Illinois Retina Associates, S.C.

    Oak Park, Illinois, 60304, United States

  • Kaiser Permanente

    Oakland, California, 94611, United States

  • MedEye Associates

    South Miami, Florida, 33143, United States

  • Medical Private Care s.r.o.

    Sokolov, Czechia

  • Mid Atlantic Retina Specialists - Hagerstown

    Hagerstown, Maryland, 21740, United States

  • North Carolina Retina Associates

    Wake Forest, North Carolina, 27587, United States

  • PTE KK Ophthalmology Clinic (Optimum Szemeszet)

    Pécs, Hungary

  • Phoenix Retina Clinical Trials, LLC - North Phoenix

    Phoenix, Arizona, 85050, United States

  • Retina Associates

    Elmhurst, Illinois, 60126, United States

  • Retina Associates New Orleans

    Metairie, Louisiana, 70006, United States

  • Retina Associates of South Texas

    San Antonio, Texas, 78240, United States

  • Retina Center of New Jersey

    Bloomfield, New Jersey, 07003, United States

  • Retina Clinic-Jardim America

    São Paulo, Brazil

  • Retina Consultants of Orange County

    Fullerton, California, 92835, United States

  • Retina Consultants of Southern California

    Redlands, California, 92374, United States

  • Retina Consultants of Texas

    Bellaire, Texas, 77401, United States

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384, United States

  • Retina Group of Florida - Fort Lauderdale

    Fort Lauderdale, Florida, 33308, United States

  • Retina Group of New England, PC

    Waterford, Connecticut, 06385, United States

  • Retina Macula Institute of Arizona

    Scottsdale, Arizona, 85255, United States

  • Retina Prime at Jardim Europa Medical Center

    Aracaju, Brazil

  • Retina Specialists of Colorado - Arvada

    Arvada, Colorado, 80002, United States

  • Retina Specialty Institute

    Pensacola, Florida, 32503, United States

  • Retina Vitreous Associates Medical Group

    Beverly Hills, California, 90211, United States

  • Retina Vitreous Associates of Florida

    Tampa, Florida, 33617, United States

  • Retina Vitreous Associates of Florida - Saint Petersburg

    St. Petersburg, Florida, 33711, United States

  • Retina Vitreous Center, PLLC

    Edmond, Oklahoma, 73013, United States

  • Retina Vitreous Surgeons of CNY, PC

    Liverpool, New York, 13088, United States

  • Retina and Vitreous of Texas

    Bellaire, Texas, 77401, United States

  • Retinal Consultants Medical Group - Modesto

    Modesto, California, 95356, United States

  • San Antonio Eye Center

    San Antonio, Texas, 78215, United States

  • Semmelweis Egyetem

    Budapest, Hungary

  • South Coast Retina Center

    Long Beach, California, 90807, United States

  • St Elisabeth Krankenhaus

    Cologne, Germany

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087, United States

  • SzTE KK Szemeszeti Klinika

    Szeged, Hungary

  • The Eye Care Institute

    Louisville, Kentucky, 40206, United States

  • The Retina Group of Washington

    Fairfax, Virginia, 22031, United States

  • The Retina Institute

    St Louis, Missouri, 63128, United States

  • Tyler Retina Consultants

    Tyler, Texas, 75703, United States

  • UNIFESP - Hospital Sao Paulo

    São Paulo, Brazil

  • University Retina and Macula Associates

    Lemont, Illinois, 60439, United States

  • VISUS, spol s.r.o.

    Náchod, Czechia

  • Verum Research, LLC

    Eugene, Oregon, 97401, United States

  • Vision Research Center at Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109, United States

  • Vitreo Retinal Associates, PC

    Worcester, Massachusetts, 01605, United States

  • Vseobecna fakultni nemocnice v Praze

    Prague, Czechia

  • Wills Eye Hospital

    Philadelphia, Pennsylvania, 19107, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.