Fenofibrate for Prevention of DR Worsening

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Diabetic Retinopathy

In brief

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.

Key facts

Study ID

NCT04661358

Run by

Jaeb Center for Health Research

People needed

563

Starts

2021-03-05

Expected to finish

2029-12-01

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Salehi Retina Institute Inc. — Huntington Beach, California, United States
• Loma Linda University — Loma Linda, California, United States
• UCLA Stein Eye Institute — Pasadena, California, United States
• Regents of the University of California, Davis, DBA University of California, Davis — Sacramento, California, United States
• The Regents of the University of California, San Francisco — San Francisco, California, United States
• National Ophthalmic Research Institute — Fort Myers, Florida, United States
• University of Florida- Jacksonville — Jacksonville, Florida, United States
• Florida Retina Institute, James A. Staman, MD, PA- Jacksonville — Jacksonville, Florida, United States
• Florida Retina Consultants — Lakeland, Florida, United States
• Florida Retina Institute, James A. Staman, MD, PA- Orlando — Orlando, Florida, United States
• Southeast Eye Institute, P.A. dba Eye Associates of Pinellas — Pinellas Park, Florida, United States
• Retina Vitreous Consultants, LLP — Sarasota, Florida, United States
• Sarasota Retina Institute — Sarasota, Florida, United States
• SEASHORE RETINA LLC DBA Retina Specialists of Tampa — Wesley Chapel, Florida, United States
• Southeast Retina Center, P.C. — Augusta, Georgia, United States
• Marietta Eye Clinic — Marietta, Georgia, United States
• Thomas Eye Group — Sandy Springs, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• UIC - Dept of Ophthalmology & Visual Sciences — Chicago, Illinois, United States
• Illinois Retina Associates SC - Oak Park Site — Oak Park, Illinois, United States
• Midwest Eye Institute — Indianapolis, Indiana, United States
• John Kenyon American Eye Institute, LLC — New Albany, Indiana, United States
• Wolfe Eye Clinic-Cedar Rapids — Hiawatha, Iowa, United States
• Kent W. Small, MD, AMC — Glendale, California, United States

Full record on ClinicalTrials.gov

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