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Diabetic RetinopathyPhase 3Protocol AFNCT04661358

Fenofibrate for Prevention of DR Worsening

A Phase 3 study testing Fenofibrate in people with Diabetic Retinopathy, run by Jaeb Center for Health Research at 66 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This randomized trial will evaluate the effect of fenofibrate compared with placebo for prevention of diabetic retinopathy (DR) worsening through 6 years of follow-up in eyes with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetic Retinopathy
What is being tested?
Fenofibrate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
563 participants
Where
66 sitesUnited States
Study dates
5 Mar 2021to Dec 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

66 sites in 1 country.

66 sites in 1 country

United States66 sites

  • Southeast Retina Center, P.C.

    Augusta, Georgia, 30909

  • Austin Research Center for Retina

    Austin, Texas, 78705

  • Austin Retina Associates

    Austin, Texas, 78705

  • Valley Eye Physicians and Surgeons

    Ayer, Massachusetts, 01432

  • Elman Retina Group, P.A.

    Baltimore, Maryland, 21237

  • Retina Consultants of Texas

    Beaumont, Texas, 77707

  • Retina Consultants of Texas, PA

    Bellaire, Texas, 77401

  • Boston Medical Center Corporation

    Boston, Massachusetts, 02118

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27517

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • UIC - Dept of Ophthalmology & Visual Sciences

    Chicago, Illinois, 60612

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

    Cleveland, Ohio, 44120

  • The Curators of the University of Missouri

    Columbia, Missouri, 65201-5276

  • Henry Ford Health System

    Detroit, Michigan, 48202-2689

  • Verum Research LLC

    Eugene, Oregon, 97401

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

  • Kent W. Small, MD, AMC

    Glendale, California, 91203-1971

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

    Grand Rapids, Michigan, 49546

  • Vitreo-Retinal Associates

    Grand Rapids, Michigan, 49546

  • Wolfe Eye Clinic-Cedar Rapids

    Hiawatha, Iowa, 52233

  • Baylor College of Medicine, Baylor Eye Physicians and Surgeons

    Houston, Texas, 77030-4101

  • Salehi Retina Institute Inc.

    Huntington Beach, California, 92647-8693

  • Midwest Eye Institute

    Indianapolis, Indiana, 46290

  • University of Florida- Jacksonville

    Jacksonville, Florida, 32209

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

    Jacksonville, Florida, 32216

  • Southeastern Retina Associates, P.C.

    Knoxville, Tennessee, 37922

  • Gunderson Health System

    La Crosse, Wisconsin, 54601

  • Florida Retina Consultants

    Lakeland, Florida, 33805

  • Retina-Vitreous Surgeons of Central NY, PC

    Liverpool, New York, 13088

  • Loma Linda University

    Loma Linda, California, 92354

  • Texas Retina Associates

    Lubbock, Texas, 79424

  • Marietta Eye Clinic

    Marietta, Georgia, 30060

  • Retina Center, PA DBA Retina Center of Minnesota

    Minneapolis, Minnesota, 55404

  • Retina-Vitreous Consultants, Inc.

    Monroeville, Pennsylvania, 15146

  • Vanderbilt Eye Institute

    Nashville, Tennessee, 37232

  • John Kenyon American Eye Institute, LLC

    New Albany, Indiana, 47150

  • MaculaCare

    New York, New York, 10021

  • Illinois Retina Associates SC - Oak Park Site

    Oak Park, Illinois, 60304

  • Dean A. McGee Eye Institute

    Oklahoma City, Oklahoma, 73104

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

    Orlando, Florida, 32806-1101

  • Mid-America Retina Consultants, P.A.

    Overland Park, Kansas, 66211

  • UCLA Stein Eye Institute

    Pasadena, California, 91103

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

    Pinellas Park, Florida, 33782

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • University of Kansas Medical Center Research Institute, Inc.

    Prairie Village, Kansas, 66208

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Retina Associates of Western NY, P.C.

    Rochester, New York, 14620-4655

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

    Sacramento, California, 95817

  • Retina Consultants, LLC

    Salem, Oregon, 97302

  • Retinal Consultants of San Antonio

    San Antonio, Texas, 78240

  • The Regents of the University of California, San Francisco

    San Francisco, California, 94110

  • Thomas Eye Group

    Sandy Springs, Georgia, 30328

  • Retina Vitreous Consultants, LLP

    Sarasota, Florida, 34233-1261

  • Sarasota Retina Institute

    Sarasota, Florida, 34239

  • University of Washington

    Seattle, Washington, 98104

  • Pittsburg Clinical Trial Consortium

    Sewickley, Pennsylvania, 15143

  • Pamela Weber, MD/Island Retina

    Shirley, New York, 11967

  • Cascade Medical Research Institute, LLC

    Springfield, Oregon, 97477

  • Washington University Ophthalmology

    St Louis, Missouri, 63110

  • Retina Research Institute, LLC

    St Louis, Missouri, 63128-1729

  • Eye Clinic of Wisconsin

    Wausau, Wisconsin, 54403

  • SEASHORE RETINA LLC DBA Retina Specialists of Tampa

    Wesley Chapel, Florida, 33544

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

    West Des Moines, Iowa, 50266-7705

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

    West Monroe, Louisiana, 71291-4452

Other trials in United States

About this study

Official title: A Randomized Clinical Trial Evaluating Fenofibrate for Prevention of Diabetic Retinopathy Worsening

This randomized trial will evaluate the effect of fenofibrate compared with placebo for prevention of diabetic retinopathy (DR) worsening through 6 years of follow-up in eyes with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline.

In addition to evaluating efficacy, this study aims to evaluate the feasibility of a model for ophthalmologists to prescribe or collaborate with a primary care provider such as an internist/endocrinologist to prescribe and monitor the drug safely. If this study demonstrates that fenofibrate is effective for reducing the onset of proliferative diabetic retinopathy (PDR) or and the results are adopted by the community of retina specialists, a new strategy to prevent vision threatening complications of diabetes could be widely adopted. Widespread use of an oral agent effective at reducing worsening of DR would decrease the numbers of patients who undergo more invasive and much more expensive treatment for DR and who are consequently at risk for side effects that adversely affect visual function. This study will also assess the relationship of glycemic variability, as measured by continuous glucose monitoring with DR outcomes. Ancillary studies will characterize functional and structural outcomes in this cohort.

Being tested
Fenofibrate, Placebo
Keywords
Fenofibrate, non-proliferative diabetic retinopathy
Medical subject headings
Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FenofibrateDrug

    Participants begin with a dose of either 160mg or 54mg fenofibrate, based on eGFR value at screening, taken once daily with food. The dose may be adjusted during follow-up based on protocol guidelines.

  • PlaceboOther

    Participants begin with a dose of either 160mg or 54mg placebo, based on eGFR value at screening, taken once daily with food. The dose may be adjusted during follow-up based on protocol guidelines.

Study groups in NCT04661358
Study groupRoleWhat they receive
Fenofibrate 160-mgExperimentalNot described
Receives: Drug: Fenofibrate
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Worsening of diabetic retinopathy

    Defined as

    • 2 or more step worsening on Early Treatment Diabetic Retinopathy Study (ETDRS) diabetic retinopathy severity on fundus photographs.
    • Development of neovascularization within the 7-modified ETDRS fields on fluorescein angiography.
    • Intraocular procedure undertaken to treat diabetic retinopathy including panretinal photocoagulation, intraocular anti-vascular endothelial growth factor, corticosteroid, or vitrectomy.

    Measured: 6- years

Secondary outcomes (4)

  1. Intraocular procedure undertaken to treat diabetic retinopathy or diabetic macular edema including PRP, intraocular anti-VEGF, corticosteroid, focal/grid laser or vitrectomy

    Measured: 6 years

  2. Development of CI-DME

    Defined as, either 1) at least a 10% increase in OCT central subfield thickness from baseline, OCT central subfield thickness greater than sex and machine-specific threshold values (Zeiss Cirrus: CST ≥290 µm in women or ≥ 305 µm in men; Heidelberg Spectralis: CST ≥305 µm in women or ≥320 µm in men), and Investigator determination that thickening cannot be attributed to any cause other than CI-DME, or 2)Intraocular DME treatment including focal/grid laser, intraocular anti-VEGF, intraocular corticosteroid, or vitrectomy

    Measured: 6 years

  3. Development of center-involved diabetic macular edema with vision loss

    Defined as either 1) an increase in OCT central subfield thickness of 10% or more from baseline, OCT central subfield thickness greater than sex and machine-specific threshold values (Zeiss Cirrus: CST ≥290 µm in women or ≥ 305 µm in men; Heidelberg Spectralis: CST ≥305 µm in women or ≥320 µm in men), investigator determination that thickening cannot be attributed to any cause other than DME, and a decrease in visual acuity from baseline of 10 or more letters at a single visit or 5 to 9 letters at 2 consecutive visits at least 21 days apart with vision loss presumed to be from DME, intraocular DME or 2) treatment including focal/grid laser, anti-VEGF, corticosteroid injection, or vitrectomy

    Measured: 6 years

  4. Visual acuity loss from any cause

    Defined as a decrease in visual acuity from baseline of 10 or more letters at a single visit or a 5 to 9-letter decrease at 2 consecutive visits at least 21 days apart regardless of whether vision loss is presumed to be from DME or any other cause

    Measured: 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2020
  2. Study start5 Mar 2021
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, double-masked, placebo-controlled clinical trial
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
563 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04661358
Sponsor's protocol ID
DRCR.net Protocol AF
Other IDs
U10EY014231
Acronym
Protocol AF
Status last verified
Jun 2026
First submitted
3 Dec 2020
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fenofibrate in people with Diabetic Retinopathy, run by Jaeb Center for Health Research at 66 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Worsening of diabetic retinopathy (time frame: 6- years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04661358.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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