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Fenofibrate for Prevention of DR Worsening
Fenofibrate for Prevention of DR Worsening

NCT04661358

Active Not RecruitingPhase 3

Sponsor: Jaeb Center for Health Research

Conditions: Diabetic Retinopathy

Interventions: Fenofibrate, Placebo

Countries: United States

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 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.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (66)
  • Glendale, California, United States
  • Huntington Beach, California, United States
  • Loma Linda, California, United States
  • Pasadena, California, United States
  • Sacramento, California, United States
  • San Francisco, California, United States
  • Fort Myers, Florida, United States
  • Jacksonville, Florida, United States
  • Jacksonville, Florida, United States
  • Lakeland, Florida, United States
  • Orlando, Florida, United States
  • Pinellas Park, Florida, United States
  • Sarasota, Florida, United States
  • Sarasota, Florida, United States
  • Wesley Chapel, Florida, United States
  • Augusta, Georgia, United States
  • Marietta, Georgia, United States
  • Sandy Springs, Georgia, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Oak Park, Illinois, United States
  • Indianapolis, Indiana, United States
  • New Albany, Indiana, United States
  • Hiawatha, Iowa, United States
  • West Des Moines, Iowa, United States
  • Overland Park, Kansas, United States
  • Prairie Village, Kansas, United States
  • West Monroe, Louisiana, United States
  • Baltimore, Maryland, United States
  • + 36 more on CT.gov