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Eye injection vs. surgery: which is better for diabetic retinopathy?

NCT ID NCT06790784

Disease control Sponsor: Jaeb Center for Health Research Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 18, 2026 · Updated 5 times

Summary

This study tests two ways to treat proliferative diabetic retinopathy, a serious eye problem caused by diabetes. One group gets eye injections of faricimab plus laser treatment; the other gets vitrectomy surgery with laser. Researchers will track vision and how many extra treatments are needed over 3 years. About 426 adults with diabetes are being recruited.

What this could mean

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

Active substance
faricimab (injection) and panretinal photocoagulation (laser) vs. vitrectomy (surgery) and endolaser
What this could lead to
If successful, this could show that a less invasive injection-plus-laser approach works as well as or better than surgery for advanced diabetic eye disease.
What could go wrong
This is a phase 3 trial, but results may not apply to all patients. Both treatments have risks like infection, bleeding, or vision loss, and the injection group may need more follow-up treatments.

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 426 people

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

Started

Aug 2025

Expected to finish

Aug 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: Individual: * ≥ 18 years old * Diagnosis of diabetes mellitus (type 1 or type 2) Study Eye:(A participant can have one or two study eyes if both eyes are eligible at screening.) * Presence of PDR requiring treatment, defined as moderate PDR or worse on global grading of ultrawide field fundus photos or NV meeting criteria for moderate PDR or worse on global grading of ultrawide field FA, confirmed by a central reading center * Best corrected visual acuity ≥49 letters (20/100 Snellen equivalent or better) Exclusion Criteria: * Individual: * Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant. * Blood pressure \> 160/100 (systolic above 160 or diastolic above 100). o If blood pressure is brought below 160/100 by anti-hypertensive treatment, individual can become eligible. * For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years. * Women of childbearing potential will be required to have pregnancy testing or use an acceptable method of pregnancy prevention. Women who are potential study participants should be questioned about the potential for pregnancy at baseline and prior to each injection. Pregnancy test is required for all women of childbearing potential at baseline. Investigator judgment is used to determine when a pregnancy test is needed during follow up. Study Eye: (A participant can have two study eyes.) * Traction retinal detachment involving the macula * Significant vitreous hemorrhage that would preclude completion of a full PRP * Significant vitreomacular traction * Any prior vitrectomy * Any prior PRP (defined as ≥100 burns outside of the posterior pole) * Treatment for DME within the prior 6 months * Intravitreal anti-VEGF for any indication, other than DME, within the prior year

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Conditions

The condition(s) this trial relates to.

proliferative diabetic retinopathy

As listed by the trial registrant

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

Proliferative diabetic retinopathy (PDR)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    34 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Austin Research Center for Retina

    RECRUITING

    Austin, Texas, 78705, United States

  • Baylor College of Medicine, Baylor Eye Physicians and Surgeons

    RECRUITING

    Houston, Texas, 77030-4101, United States

  • Boston Medical Center Corporation

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • California Retina Consultants

    RECRUITING

    Santa Barbara, California, 93103-4223, United States

  • Elman Retina Group, P.A.

    RECRUITING

    Baltimore, Maryland, 21237, United States

  • Emory Eye Center

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Florida Retina Consultants

    RECRUITING

    Lakeland, Florida, 33805, United States

  • Illinois Retina Associates SC Oak Park Site

    RECRUITING

    Oak Park, Illinois, 60304, United States

  • Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana

    RECRUITING

    West Monroe, Louisiana, 71291-4452, United States

  • Joslin Diabetes Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Loma Linda University

    RECRUITING

    Loma Linda, California, 92354, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mid-America Retina Consultants, P.A.

    RECRUITING

    Overland, Kansas, 66211, United States

  • Midwest Eye Institute

    RECRUITING

    Carmel, Indiana, 46032, United States

  • Ophthalmic Partners of Florida, PA dba Central Florida Retina

    RECRUITING

    Orlando, Florida, 32806, United States

  • Retina Associates of Florida, LLC

    RECRUITING

    Tampa, Florida, 33609, United States

  • Retina Associates of Southern California

    RECRUITING

    Huntington Beach, California, 92647, United States

  • Retina Associates of Western NY, P.C.

    RECRUITING

    Rochester, New York, 14620, United States

  • Retina Consultants of Minnesota

    RECRUITING

    Saint Louis Park, Minnesota, 55416, United States

  • Retina Consultants of Texas, PA

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Retina Research Institute, LLC

    RECRUITING

    St Louis, Missouri, 63128, United States

  • Retina Vitreous Center

    RECRUITING

    Edmond, Oklahoma, 73013, United States

  • Retina-Vitreous Consultants, Inc.

    RECRUITING

    Monroeville, Pennsylvania, 15146, United States

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Southeast Retina Center, P.C.

    RECRUITING

    Augusta, Georgia, 30909, United States

  • Texas Retina Associates

    RECRUITING

    Lubbock, Texas, 79424, United States

  • The Trustees of Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Thomas Eye Group

    RECRUITING

    Sandy Springs, Georgia, 30328, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Florida - Jacksonville

    RECRUITING

    Jacksonville, Florida, 32209, United States

  • University of Kentucky Advanced Eye Care

    RECRUITING

    Lexington, Kentucky, 40508, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27517-8923, United States

  • West Coast Retina Medical Group, Inc.

    RECRUITING

    San Francisco, California, 94109, United States

  • Wolfe Clinic, P.C.- West Des Moines

    RECRUITING

    West Des Moines, Iowa, 50266, United States

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