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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: Recruiting Phase 3 study of Diabetic Retinopathy, sponsored by Jaeb Center for Health Research.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Defined as * 2 or more step worsening on Early Treatment Diabetic Retinopathy Study (ETDRS) diabetic retinopathy severity on fundus photographs. * Development of neovascularization within the 7-modified ETDRS fields on fluorescein angiography. * Intraocular procedure undertaken to treat diabetic retinopathy including panretinal photocoagulation, intraocular anti-vascular endothelial growth factor, corticosteroid, or vitrectomy.
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 |
What NCT04661358 shows while recruiting
NCT04661358 is an interventional study that assigns participants to a tested intervention. The registered 560 participants enrollment target is mid-sized for trials with a published cap, below the 1,667-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (66% lower).
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 names 20 study sites across 4 states, led by 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.
Learn More About Clinical Trials
Similar trials for Diabetic Retinopathy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04661358's enrollment target sits among peer trials
560 16th of 57 higher than 42 of 57 other Diabetic Retinopathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Retinopathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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