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Using fenofibrate to prevent worsening of diabetic retinopathy

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

Phase 3 Interventional Jaeb Center for Health Research · NCT04661358

This study is testing if the medication fenofibrate can help prevent the worsening of diabetic retinopathy in adults with diabetes.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment560 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorJaeb Center for Health Research Academic / other
Locations66 sites (Glendale, California and 65 other locations)
Trial IDNCT04661358 on ClinicalTrials.gov

What this trial studies

This randomized trial evaluates the effectiveness of fenofibrate compared to a placebo in preventing the worsening of diabetic retinopathy (DR) over a six-year period in patients with mild to moderately severe non-proliferative diabetic retinopathy. The study also aims to establish a collaborative model for ophthalmologists and primary care providers to safely prescribe and monitor the medication. If successful, this approach could lead to a significant reduction in the progression to more severe forms of DR, potentially decreasing the need for invasive treatments. The trial includes patients aged 18 to 80 with type 1 or type 2 diabetes and specific visual acuity criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with type 1 or type 2 diabetes and mild to moderately severe non-proliferative diabetic retinopathy.

Not a fit: Patients with current clinically significant diabetic macular edema or other conditions affecting visual acuity may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new oral treatment option to prevent vision-threatening complications of diabetes.

How similar studies have performed: Previous studies have shown promise in using fenofibrate for diabetic retinopathy, but this specific approach is being evaluated in a novel context.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Glendale, California and 65 other locations

+16 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetic RetinopathyFenofibratenon-proliferative diabetic retinopathy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.