Fenofibrate for Prevention of DR Worsening (NCT04661358)
A Randomized Clinical Trial Evaluating Fenofibrate for Prevention of Diabetic Retinopathy Worsening
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Kent W. Small, MD, AMC — Glendale, California
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (66 Sites)
Showing the first 25 of 66 sites.
- Kent W. Small, MD, AMC — Glendale, California
- Salehi Retina Institute Inc. — Huntington Beach, California
- Loma Linda University — Loma Linda, California
- UCLA Stein Eye Institute — Pasadena, California
- Regents of the University of California, Davis, DBA University of California, Davis — Sacramento, California
- The Regents of the University of California, San Francisco — San Francisco, California
- National Ophthalmic Research Institute — Fort Myers, Florida
- University of Florida- Jacksonville — Jacksonville, Florida
- Florida Retina Institute, James A. Staman, MD, PA- Jacksonville — Jacksonville, Florida
- Florida Retina Consultants — Lakeland, Florida
- Florida Retina Institute, James A. Staman, MD, PA- Orlando — Orlando, Florida
- Southeast Eye Institute, P.A. dba Eye Associates of Pinellas — Pinellas Park, Florida
- Retina Vitreous Consultants, LLP — Sarasota, Florida
- Sarasota Retina Institute — Sarasota, Florida
- SEASHORE RETINA LLC DBA Retina Specialists of Tampa — Wesley Chapel, Florida
- Southeast Retina Center, P.C. — Augusta, Georgia
- Marietta Eye Clinic — Marietta, Georgia
- Thomas Eye Group — Sandy Springs, Georgia
- Northwestern University — Chicago, Illinois
- Rush University Medical Center — Chicago, Illinois
- UIC - Dept of Ophthalmology & Visual Sciences — Chicago, Illinois
- Illinois Retina Associates SC - Oak Park Site — Oak Park, Illinois
- Midwest Eye Institute — Indianapolis, Indiana
- John Kenyon American Eye Institute, LLC — New Albany, Indiana
- Wolfe Eye Clinic-Cedar Rapids — Hiawatha, Iowa
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Camera Qualification Study — Norco, California
- A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy — Phoenix, Arizona
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Explore by condition: All Diabetic Retinopathy clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.