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Cheap pill could save millions from blindness, major trial launches

NCT ID NCT04661358

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 30, 2026 · Updated 2 times

Summary

This study tests whether fenofibrate, a drug already used for high cholesterol, can prevent diabetic retinopathy from worsening in people with mild to moderate disease. About 560 adults with diabetes will take either fenofibrate or a placebo for up to 6 years. The goal is to see if the drug can reduce the need for invasive eye treatments like laser surgery or injections.

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

563 people

The number who actually took part.

Started

Mar 2021

Expected to finish

Dec 2029

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 to 80 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.

Key Inclusion Criteria * Age ≥18 years and \< 80 years. * Type 1 or type 2 diabetes. * At least one eye with the following: * Mild to moderately severe NPDR (defined by ETDRS DR severity level 35 to 47), confirmed by central Reading Center grading of fundus photographs. * Best-corrected E-ETDRS visual acuity letter score of ≥74 (approximate Snellen equivalent 20/32 or better). If best corrected letter score is 74-78, investigator must verify that vision loss is not due to the presence of CI-DME, cataract, or other condition that may affect visual acuity during the course of the study. * If only one eye is eligible, the non-study eye must have at least microaneurysms only (DR severity level 20) Key Exclusion Criteria Eye-level exclusion criteria (the eye is ineligible if any of the following is met): * Current CI-DME based on clinical exam or OCT central subfield thickness (CST) * Zeiss Cirrus: CST ≥290 µm in women or ≥ 305 µm in men * Heidelberg Spectralis: CST ≥305 µm in women or ≥320 µm in men * Any prior treatment for DME or DR, other than focal/grid laser. If the eye has a history of focal/grid laser, it must be at least 12 months prior. * History of intraocular anti-VEGF or corticosteroid treatment within the prior year for any indication Participant-level exclusion criterion (the participant is ineligible if the following criterion is met): • Decreased renal function, defined as requiring dialysis or central laboratory eGFR value \< 45 mL/min/1.73 m2

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Austin Research Center for Retina

    Austin, Texas, 78705, United States

  • Austin Retina Associates

    Austin, Texas, 78705, United States

  • Baylor College of Medicine, Baylor Eye Physicians and Surgeons

    Houston, Texas, 77030-4101, United States

  • Boston Medical Center Corporation

    Boston, Massachusetts, 02118, United States

  • Cascade Medical Research Institute, LLC

    Springfield, Oregon, 97477, United States

  • Dean A. McGee Eye Institute

    Oklahoma City, Oklahoma, 73104, United States

  • Elman Retina Group, P.A.

    Baltimore, Maryland, 21237, United States

  • Eye Clinic of Wisconsin

    Wausau, Wisconsin, 54403, United States

  • Florida Retina Consultants

    Lakeland, Florida, 33805, United States

  • Florida Retina Institute, James A. Staman, MD, PA- Jacksonville

    Jacksonville, Florida, 32216, United States

  • Florida Retina Institute, James A. Staman, MD, PA- Orlando

    Orlando, Florida, 32806-1101, United States

  • Foundation for Vision Research and Retina Specialists of Michigan, P.C.

    Grand Rapids, Michigan, 49546, United States

  • Gunderson Health System

    La Crosse, Wisconsin, 54601, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202-2689, United States

  • Illinois Retina Associates SC - Oak Park Site

    Oak Park, Illinois, 60304, United States

  • John Kenyon American Eye Institute, LLC

    New Albany, Indiana, 47150, United States

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

    West Monroe, Louisiana, 71291-4452, United States

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215, United States

  • Kent W. Small, MD, AMC

    Glendale, California, 91203-1971, United States

  • Loma Linda University

    Loma Linda, California, 92354, United States

  • MaculaCare

    New York, New York, 10021, United States

  • Marietta Eye Clinic

    Marietta, Georgia, 30060, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mid-America Retina Consultants, P.A.

    Overland Park, Kansas, 66211, United States

  • Midwest Eye Institute

    Indianapolis, Indiana, 46290, United States

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Pamela Weber, MD/Island Retina

    Shirley, New York, 11967, United States

  • Pittsburg Clinical Trial Consortium

    Sewickley, Pennsylvania, 15143, United States

  • Regents of the University of California, Davis, DBA University of California, Davis

    Sacramento, California, 95817, United States

  • Retina Associates of Western NY, P.C.

    Rochester, New York, 14620-4655, United States

  • Retina Center, PA DBA Retina Center of Minnesota

    Minneapolis, Minnesota, 55404, United States

  • Retina Consultants of Texas

    Beaumont, Texas, 77707, United States

  • Retina Consultants of Texas, PA

    Bellaire, Texas, 77401, United States

  • Retina Consultants, LLC

    Salem, Oregon, 97302, United States

  • Retina Research Institute, LLC

    St Louis, Missouri, 63128-1729, United States

  • Retina Vitreous Consultants, LLP

    Sarasota, Florida, 34233-1261, United States

  • Retina-Vitreous Consultants, Inc.

    Monroeville, Pennsylvania, 15146, United States

  • Retina-Vitreous Surgeons of Central NY, PC

    Liverpool, New York, 13088, United States

  • Retinal Consultants of San Antonio

    San Antonio, Texas, 78240, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • SEASHORE RETINA LLC DBA Retina Specialists of Tampa

    Wesley Chapel, Florida, 33544, United States

  • Salehi Retina Institute Inc.

    Huntington Beach, California, 92647-8693, United States

  • Sarasota Retina Institute

    Sarasota, Florida, 34239, United States

  • Southeast Eye Institute, P.A. dba Eye Associates of Pinellas

    Pinellas Park, Florida, 33782, United States

  • Southeast Retina Center, P.C.

    Augusta, Georgia, 30909, United States

  • Southeastern Retina Associates, P.C.

    Knoxville, Tennessee, 37922, United States

  • Texas Retina Associates

    Lubbock, Texas, 79424, United States

  • The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine

    Cleveland, Ohio, 44120, United States

  • The Curators of the University of Missouri

    Columbia, Missouri, 65201-5276, United States

  • The Regents of the University of California, San Francisco

    San Francisco, California, 94110, United States

  • Thomas Eye Group

    Sandy Springs, Georgia, 30328, United States

  • UCLA Stein Eye Institute

    Pasadena, California, 91103, United States

  • UIC - Dept of Ophthalmology & Visual Sciences

    Chicago, Illinois, 60612, United States

  • University of Florida- Jacksonville

    Jacksonville, Florida, 32209, United States

  • University of Kansas Medical Center Research Institute, Inc.

    Prairie Village, Kansas, 66208, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27517, United States

  • University of Washington

    Seattle, Washington, 98104, United States

  • Valley Eye Physicians and Surgeons

    Ayer, Massachusetts, 01432, United States

  • Vanderbilt Eye Institute

    Nashville, Tennessee, 37232, United States

  • Verum Research LLC

    Eugene, Oregon, 97401, United States

  • Vitreo-Retinal Associates

    Grand Rapids, Michigan, 49546, United States

  • Washington University Ophthalmology

    St Louis, Missouri, 63110, United States

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

    West Des Moines, Iowa, 50266-7705, United States

  • Wolfe Eye Clinic-Cedar Rapids

    Hiawatha, Iowa, 52233, United States

More trials for these conditions

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