Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

This randomized trial will evaluate the effect of fenofibrate compared with placebo for prevention of diabetic retinopathy (DR) worsening through 4 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.

Official Title

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

Keywords

Diabetic Retinopathy, Fenofibrate, non-proliferative diabetic retinopathy, Retinal Diseases, Fenofibrate 160-mg

Eligibility

You can join if…

Open to people ages 18-80

  • 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 ≥79 (approximate Snellen equivalent 20/25 or better).
  • If only one eye is eligible, the non-study eye must have at least microaneurysms only (DR severity level 20)

You CAN'T join if...

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

Locations

  • The Regents of the University of California, San Francisco accepting new patients
    San Francisco California 94110 United States
  • Regents of the University of California, Davis, DBA University of California, Davis accepting new patients
    Sacramento California 95817 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jaeb Center for Health Research
ID
NCT04661358
Phase
Phase 3 Diabetes Research Study
Study Type
Interventional
Participants
Expecting 910 study participants
Last Updated