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Fenofibrate for Preventing Diabetic Retinopathy Worsening

This study is looking at whether fenofibrate, a medication, can help prevent diabetic retinopathy (DR) from getting worse. Diabetic retinopathy is an eye condition that can affect people with diabetes. You might be able to join if you are between 18 and 80 years old, have type 1 or type 2 diabetes, and have mild to moderately severe non-proliferative diabetic retinopathy (NPDR) in at least one eye. The study will compare fenofibrate to a placebo (an inactive pill that looks like the study drug) over 6 years to see if fenofibrate can reduce the worsening of your diabetic retinopathy. The goal is to find new ways to prevent vision problems caused by diabetes.

Study design
This is a randomized study, meaning participants are randomly assigned to receive either fenofibrate or a placebo. It aims to enroll 563 participants.
What's involved
You would take fenofibrate or a placebo once daily with food. The dose may be adjusted during the study based on guidelines.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 years to measure the worsening of diabetic retinopathy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04661358

Fenofibrate for Prevention of DR Worsening

Active, Not Recruiting
PHASE3Ages 18–80InterventionalTreatment
Jaeb Center for Health Research
~563 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:FenofibratePlacebo

At a glance

Recruiting sites
0 of 66 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Worsening of diabetic retinopathy
Measured over 6- years

Conditions

Diabetic Retinopathy

Explore related trials

Diabetic Retinopathy

Where it's being run

66 sites across 23 states
Florida9
Texas7
California6
Illinois4
New York4
Oregon4
Georgia3
Massachusetts3

Study leadership

  • Emily Y Chew, MD · STUDY_CHAIR · National Institutes of Health (NIH)

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)

Exclusion

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

What this trial measures

  • Worsening of diabetic retinopathy6- years

    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.