Cheap pill could save millions from blindness, major trial launches
NCT ID NCT04661358
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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563 people
The number who actually took part.
- Started
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Mar 2021
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Get notified about this study
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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
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Austin Research Center for Retina
Austin, Texas, 78705, United States
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Austin Retina Associates
Austin, Texas, 78705, United States
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Baylor College of Medicine, Baylor Eye Physicians and Surgeons
Houston, Texas, 77030-4101, United States
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Boston Medical Center Corporation
Boston, Massachusetts, 02118, United States
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Cascade Medical Research Institute, LLC
Springfield, Oregon, 97477, United States
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Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, 73104, United States
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Elman Retina Group, P.A.
Baltimore, Maryland, 21237, United States
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Eye Clinic of Wisconsin
Wausau, Wisconsin, 54403, United States
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Florida Retina Consultants
Lakeland, Florida, 33805, United States
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Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
Jacksonville, Florida, 32216, United States
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Florida Retina Institute, James A. Staman, MD, PA- Orlando
Orlando, Florida, 32806-1101, United States
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Foundation for Vision Research and Retina Specialists of Michigan, P.C.
Grand Rapids, Michigan, 49546, United States
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Gunderson Health System
La Crosse, Wisconsin, 54601, United States
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Henry Ford Health System
Detroit, Michigan, 48202-2689, United States
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Illinois Retina Associates SC - Oak Park Site
Oak Park, Illinois, 60304, United States
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John Kenyon American Eye Institute, LLC
New Albany, Indiana, 47150, United States
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Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
West Monroe, Louisiana, 71291-4452, United States
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Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
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Kent W. Small, MD, AMC
Glendale, California, 91203-1971, United States
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Loma Linda University
Loma Linda, California, 92354, United States
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MaculaCare
New York, New York, 10021, United States
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Marietta Eye Clinic
Marietta, Georgia, 30060, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Mid-America Retina Consultants, P.A.
Overland Park, Kansas, 66211, United States
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Midwest Eye Institute
Indianapolis, Indiana, 46290, United States
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National Ophthalmic Research Institute
Fort Myers, Florida, 33912, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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Oregon Health & Science University
Portland, Oregon, 97239, United States
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Pamela Weber, MD/Island Retina
Shirley, New York, 11967, United States
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Pittsburg Clinical Trial Consortium
Sewickley, Pennsylvania, 15143, United States
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Regents of the University of California, Davis, DBA University of California, Davis
Sacramento, California, 95817, United States
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Retina Associates of Western NY, P.C.
Rochester, New York, 14620-4655, United States
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Retina Center, PA DBA Retina Center of Minnesota
Minneapolis, Minnesota, 55404, United States
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Retina Consultants of Texas
Beaumont, Texas, 77707, United States
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Retina Consultants of Texas, PA
Bellaire, Texas, 77401, United States
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Retina Consultants, LLC
Salem, Oregon, 97302, United States
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Retina Research Institute, LLC
St Louis, Missouri, 63128-1729, United States
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Retina Vitreous Consultants, LLP
Sarasota, Florida, 34233-1261, United States
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Retina-Vitreous Consultants, Inc.
Monroeville, Pennsylvania, 15146, United States
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Retina-Vitreous Surgeons of Central NY, PC
Liverpool, New York, 13088, United States
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Retinal Consultants of San Antonio
San Antonio, Texas, 78240, United States
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Rush University Medical Center
Chicago, Illinois, 60612, United States
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SEASHORE RETINA LLC DBA Retina Specialists of Tampa
Wesley Chapel, Florida, 33544, United States
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Salehi Retina Institute Inc.
Huntington Beach, California, 92647-8693, United States
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Sarasota Retina Institute
Sarasota, Florida, 34239, United States
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Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
Pinellas Park, Florida, 33782, United States
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Southeast Retina Center, P.C.
Augusta, Georgia, 30909, United States
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Southeastern Retina Associates, P.C.
Knoxville, Tennessee, 37922, United States
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Texas Retina Associates
Lubbock, Texas, 79424, United States
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The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio, 44120, United States
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The Curators of the University of Missouri
Columbia, Missouri, 65201-5276, United States
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The Regents of the University of California, San Francisco
San Francisco, California, 94110, United States
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Thomas Eye Group
Sandy Springs, Georgia, 30328, United States
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UCLA Stein Eye Institute
Pasadena, California, 91103, United States
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UIC - Dept of Ophthalmology & Visual Sciences
Chicago, Illinois, 60612, United States
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University of Florida- Jacksonville
Jacksonville, Florida, 32209, United States
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University of Kansas Medical Center Research Institute, Inc.
Prairie Village, Kansas, 66208, United States
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27517, United States
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University of Washington
Seattle, Washington, 98104, United States
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Valley Eye Physicians and Surgeons
Ayer, Massachusetts, 01432, United States
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Vanderbilt Eye Institute
Nashville, Tennessee, 37232, United States
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Verum Research LLC
Eugene, Oregon, 97401, United States
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Vitreo-Retinal Associates
Grand Rapids, Michigan, 49546, United States
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Washington University Ophthalmology
St Louis, Missouri, 63110, United States
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Wolfe Clinic, P.C.- West Des Moines
West Des Moines, Iowa, 50266-7705, United States
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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.
- Could a work health check catch diabetic eye damage before it steals sight?
- Eye scans as a window to the body: study probes retinal imaging across diseases
- Can a new gel make eye injections less painful?
- AI eye doctor: could software catch diabetic blindness sooner?
- Can eye scans reveal hidden clues about diabetes damage?
- AI could predict which eye treatments work best for Diabetes-Related vision loss