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Fenofibrate for Prevention of DR Worsening
NCT04661358 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Fenofibrate
Study Locations (20)
Florida
- National Ophthalmic Research Institute — Fort Myers
- University of Florida- Jacksonville — Jacksonville
- Florida Retina Institute, James A. Staman, MD, PA- Jacksonville — Jacksonville
- Florida Retina Consultants — Lakeland
- Florida Retina Institute, James A. Staman, MD, PA- Orlando — Orlando
- Southeast Eye Institute, P.A. dba Eye Associates of Pinellas — Pinellas Park
- Retina Vitreous Consultants, LLP — Sarasota
- Sarasota Retina Institute — Sarasota
- SEASHORE RETINA LLC DBA Retina Specialists of Tampa — Wesley Chapel
California
- Kent W. Small, MD, AMC — Glendale
- Salehi Retina Institute Inc. — Huntington Beach
- Loma Linda University — Loma Linda
- UCLA Stein Eye Institute — Pasadena
- Regents of the University of California, Davis, DBA University of California, Davis — Sacramento
- The Regents of the University of California, San Francisco — San Francisco
Georgia
- Southeast Retina Center, P.C. — Augusta
- Marietta Eye Clinic — Marietta
- Thomas Eye Group — Sandy Springs
Illinois
- Northwestern University — Chicago
- Rush University Medical Center — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 560 participants |
| Start Date | 2021-03-05 |
| Est. Completion | 2029-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04661358
The ClinicalTrials.gov registry entry for NCT04661358 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 560 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jaeb Center for Health Research, which has 134 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Diabetic Retinopathy appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04661358 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04661358 about?
NCT04661358 is a clinical study titled "Fenofibrate for Prevention of DR Worsening". 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, th...
What is the current status of trial NCT04661358?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 560 participants. The study started on 2021-03-05. Estimated completion is 2029-12.
What conditions does trial NCT04661358 study?
This clinical trial studies the following conditions: Diabetic Retinopathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04661358?
The interventions under investigation include: Placebo (OTHER), Fenofibrate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04661358?
This trial is sponsored by Jaeb Center for Health Research, which has 134 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04661358 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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