Fenofibrate for Prevention of DR Worsening (Protocol AF)

  • STATUS
    Recruiting
  • End date
    Apr 13, 2027
  • participants needed
    910
  • sponsor
    Jaeb Center for Health Research
Updated on 13 July 2022
diabetes
insulin
pupil dilation
microaneurysms
severe nonproliferative diabetic retinopathy

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.

Details
Condition Diabetic Retinopathy
Treatment Placebo, Fenofibrate, Fenofibrate 160mg
Clinical Study IdentifierNCT04661358
SponsorJaeb Center for Health Research
Last Modified on13 July 2022

Eligibility

Yes No Not Sure

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 ≥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)

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
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