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NCT04661358 · ClinicalTrials.gov registry record · Phase 3
Fenofibrate for Prevention of DR Worsening
A Phase 3 study of Diabetic Retinopathy, sponsored by Jaeb Center for Health Research.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 560
- Enrollment target
- 20
- Study locations
NCT04661358 is a Phase 3 study of Diabetic Retinopathy that is actively recruiting participants, run by Jaeb Center for Health Research. The registered enrollment target is 560 participants, below the 1,667-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (66% lower). The trial reports 20 study locations across 4 states.
The verdict
NCT04661358, a Phase 3 study of Diabetic Retinopathy, is actively recruiting participants, sponsored by Jaeb Center for Health Research.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 560 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 560 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,667-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (66% lower). The listed sponsor is Jaeb Center for Health Research, which has 119 total studies on file at ClinicalTrials.gov.
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.
NCT04661358 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Florida, California, Georgia.
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.
What interventions are being tested in trial NCT04661358?
The interventions under investigation include: Placebo (OTHER), Fenofibrate (DRUG).
Who is sponsoring clinical trial NCT04661358?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
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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