Fenofibrate for Prevention of DR Worsening
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 560
Not provided
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 (61)
Foundation for Vision Research and Retina Specialists of Michigan, P.C.
🇺🇸Grand Rapids, Michigan, United States
Salehi Retina Institute Inc.
🇺🇸Huntington Beach, California, United States
Pittsburg Clinical Trial Consortium
🇺🇸Sewickley, Pennsylvania, United States
Loma Linda University
🇺🇸Loma Linda, California, United States
Illinois Retina Associates SC - Oak Park Site
🇺🇸Oak Park, Illinois, United States
Sarasota Retina Institute
🇺🇸Sarasota, Florida, United States
Marietta Eye Clinic
🇺🇸Marietta, Georgia, United States
Retina Research Institute, LLC
🇺🇸Saint Louis, Missouri, United States
Kent W. Small, MD, AMC
🇺🇸Glendale, California, United States
Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
🇺🇸Jacksonville, Florida, United States
Wolfe Clinic, P.C.- West Des Moines
🇺🇸West Des Moines, Iowa, United States
Florida Retina Consultants
🇺🇸Lakeland, Florida, United States
Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
🇺🇸Pinellas Park, Florida, United States
Thomas Eye Group
🇺🇸Sandy Springs, Georgia, United States
National Ophthalmic Research Institute
🇺🇸Fort Myers, Florida, United States
SEASHORE RETINA LLC DBA Retina Specialists of Tampa
🇺🇸Wesley Chapel, Florida, United States
Valley Eye Physicians and Surgeons
🇺🇸Ayer, Massachusetts, United States
Vitreo-Retinal Associates
🇺🇸Grand Rapids, Michigan, United States
Mid-America Retina Consultants, P.A.
🇺🇸Overland Park, Kansas, United States
Wolfe Eye Clinic-Cedar Rapids
🇺🇸Hiawatha, Iowa, United States
MaculaCare
🇺🇸New York, New York, United States
University of Florida- Jacksonville
🇺🇸Jacksonville, Florida, United States
Retina Vitreous Consultants, LLP
🇺🇸Sarasota, Florida, United States
The Curators of the University of Missouri
🇺🇸Columbia, Missouri, United States
Southeast Retina Center, P.C.
🇺🇸Augusta, Georgia, United States
Retina-Vitreous Surgeons of Central NY, PC
🇺🇸Liverpool, New York, United States
Retina Consultants, LLC
🇺🇸Salem, Oregon, United States
Southeastern Retina Associates, P.C.
🇺🇸Knoxville, Tennessee, United States
Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
🇺🇸West Monroe, Louisiana, United States
Texas Retina Associates
🇺🇸Lubbock, Texas, United States
John Kenyon American Eye Institute, LLC
🇺🇸New Albany, Indiana, United States
Retina Associates of Western NY, P.C.
🇺🇸Rochester, New York, United States
Verum Research LLC
🇺🇸Eugene, Oregon, United States
Gunderson Health System
🇺🇸La Crosse, Wisconsin, United States
Eye Clinic of Wisconsin
🇺🇸Wausau, Wisconsin, United States
Pamela Weber, MD/Island Retina
🇺🇸Shirley, New York, United States
Retina-Vitreous Consultants, Inc.
🇺🇸Monroeville, Pennsylvania, United States
Retina Consultants of Texas, PA
🇺🇸Bellaire, Texas, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine
🇺🇸Cleveland, Ohio, United States
Elman Retina Group, P.A.
🇺🇸Baltimore, Maryland, United States
University of Washington
🇺🇸Seattle, Washington, United States
Boston Medical Center Corporation
🇺🇸Boston, Massachusetts, United States
Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States
Baylor College of Medicine, Baylor Eye Physicians and Surgeons
🇺🇸Houston, Texas, United States
Midwest Eye Institute
🇺🇸Indianapolis, Indiana, United States
Retina Center, PA DBA Retina Center of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Retinal Consultants of San Antonio
🇺🇸San Antonio, Texas, United States
The Regents of the University of California, San Francisco
🇺🇸San Francisco, California, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Dean A. McGee Eye Institute
🇺🇸Oklahoma City, Oklahoma, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Vanderbilt Eye Institute
🇺🇸Nashville, Tennessee, United States
Cascade Medical Research Institute, LLC
🇺🇸Springfield, Oregon, United States
Regents of the University of California, Davis, DBA University of California, Davis
🇺🇸Sacramento, California, United States
Florida Retina Institute, James A. Staman, MD, PA- Orlando
🇺🇸Orlando, Florida, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Austin Research Center for Retina
🇺🇸Austin, Texas, United States
Austin Retina Associates
🇺🇸Austin, Texas, United States