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Status:

RECRUITING

Fenofibrate for Prevention of DR Worsening

Lead Sponsor:

Jaeb Center for Health Research

Collaborating Sponsors:

National Institutes of Health (NIH)

National Eye Institute (NEI)

Conditions:

Diabetic Retinopathy

Eligibility:

All Genders

18-80 years

Phase:

PHASE3

Brief 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 s...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 5 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 1 2029

    Estimated Enrollment :

    560 Patients enrolled

    Trial Details

    Trial ID

    NCT04661358

    Start Date

    March 5 2021

    End Date

    December 1 2029

    Last Update

    November 13 2025

    Active Locations (66)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 17 (66 locations)

    1

    Kent W. Small, MD, AMC

    Glendale, California, United States, 91203-1971

    2

    Salehi Retina Institute Inc.

    Huntington Beach, California, United States, 92647-8693

    3

    Loma Linda University

    Loma Linda, California, United States, 92354

    4

    UCLA Stein Eye Institute

    Pasadena, California, United States, 91103