Fenofibrate for Prevention of DR Worsening

Phase 3

Recruiting

• Conditions: Diabetic Retinopathy
• Interventions: Other: Placebo; Drug: Fenofibrate

• Registration Number: NCT04661358
• Lead Sponsor: Jaeb Center for Health Research

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-10
• Study Start: 2021-03-05
• Status Verified: 2024-08
• Last Update Submitted: 2025-06-26
• Last Update Posted: 2025-07-01
• Primary Completion: 2029-04
• Study Completion: 2029-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Fenofibrate 160-mg	Fenofibrate	-

Primary Outcome Measures

Name	Time	Method
Worsening of diabetic retinopathy	6- years	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.

Secondary Outcome Measures

Name	Time	Method
Intraocular procedure undertaken to treat diabetic retinopathy or diabetic macular edema including PRP, intraocular anti-VEGF, corticosteroid, focal/grid laser or vitrectomy	6 years
Development of CI-DME	6 years	Defined as, either 1) at least a 10% increase in OCT central subfield thickness from baseline, OCT central subfield thickness greater than sex and machine-specific threshold values (Zeiss Cirrus: CST ≥290 µm in women or ≥ 305 µm in men; Heidelberg Spectralis: CST ≥305 µm in women or ≥320 µm in men), and Investigator determination that thickening cannot be attributed to any cause other than CI-DME, or 2)Intraocular DME treatment including focal/grid laser, intraocular anti-VEGF, intraocular corticosteroid, or vitrectomy
Development of center-involved diabetic macular edema with vision loss	6 years	Defined as either 1) an increase in OCT central subfield thickness of 10% or more from baseline, OCT central subfield thickness greater than sex and machine-specific threshold values (Zeiss Cirrus: CST ≥290 µm in women or ≥ 305 µm in men; Heidelberg Spectralis: CST ≥305 µm in women or ≥320 µm in men), investigator determination that thickening cannot be attributed to any cause other than DME, and a decrease in visual acuity from baseline of 10 or more letters at a single visit or 5 to 9 letters at 2 consecutive visits at least 21 days apart with vision loss presumed to be from DME, intraocular DME or 2) treatment including focal/grid laser, anti-VEGF, corticosteroid injection, or vitrectomy
Visual acuity loss from any cause	6 years	Defined as a decrease in visual acuity from baseline of 10 or more letters at a single visit or a 5 to 9-letter decrease at 2 consecutive visits at least 21 days apart regardless of whether vision loss is presumed to be from DME or any other cause

Trial Locations

Locations (63)

Kent W. Small, MD, AMC; 🇺🇸 Glendale, California, United States

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

Scroll for more (53 remaining)