A Randomized Clinical Trial Evaluating Fenofibrate for Prevention of Diabetic Retinopathy Worsening

Who is this study for? Patients with Diabetic Retinopathy
What treatments are being studied? Fenofibrate
Status: Recruiting
Location: See all (64) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age ≥18 years and \< 80 years.

• Type 1 or type 2 diabetes.

• At least one eye with the following:

‣ Mild to moderately severe NPDR (defined by ETDRS DR severity level 35 to 47), confirmed by central Reading Center grading of fundus photographs.

⁃ Best-corrected E-ETDRS visual acuity letter score of ≥74 (approximate Snellen equivalent 20/32 or better). If best corrected letter score is 74-78, investigator must verify that vision loss is not due to the presence of CI-DME, cataract, or other condition that may affect visual acuity during the course of the study.

• If only one eye is eligible, the non-study eye must have at least microaneurysms only (DR severity level 20)

Locations
United States
California
Kent W. Small, MD, AMC
RECRUITING
Glendale
Salehi Retina Institute Inc.
RECRUITING
Huntington Beach
Loma Linda University
RECRUITING
Loma Linda
UCLA Stein Eye Institute
RECRUITING
Pasadena
Regents of the University of California, Davis, DBA University of California, Davis
RECRUITING
Sacramento
The Regents of the University of California, San Francisco
RECRUITING
San Francisco
Florida
National Ophthalmic Research Institute
RECRUITING
Fort Myers
Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
RECRUITING
Jacksonville
University of Florida- Jacksonville
RECRUITING
Jacksonville
Florida Retina Consultants
RECRUITING
Lakeland
Florida Retina Institute, James A. Staman, MD, PA- Orlando
RECRUITING
Orlando
Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
RECRUITING
Pinellas Park
Retina Vitreous Consultants, LLP
RECRUITING
Sarasota
Sarasota Retina Institute
RECRUITING
Sarasota
SEASHORE RETINA LLC DBA Retina Specialists of Tampa
RECRUITING
Wesley Chapel
Georgia
Southeast Retina Center, P.C.
RECRUITING
Augusta
Marietta Eye Clinic
RECRUITING
Marietta
Thomas Eye Group
RECRUITING
Sandy Springs
Iowa
Wolfe Eye Clinic-Cedar Rapids
RECRUITING
Hiawatha
Wolfe Clinic, P.C.- West Des Moines
RECRUITING
West Des Moines
Illinois
Northwestern University
RECRUITING
Chicago
Rush University Medical Center
RECRUITING
Chicago
Illinois Retina Associates SC - Oak Park Site
RECRUITING
Oak Park
Indiana
Midwest Eye Institute
RECRUITING
Indianapolis
John Kenyon American Eye Institute, LLC
RECRUITING
New Albany
Kansas
Mid-America Retina Consultants, P.A.
RECRUITING
Overland Park
Louisiana
Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
RECRUITING
West Monroe
Massachusetts
Valley Eye Physicians and Surgeons
RECRUITING
Ayer
Boston Medical Center Corporation
RECRUITING
Boston
Joslin Diabetes Center
RECRUITING
Boston
Maryland
Elman Retina Group, P.A.
RECRUITING
Baltimore
Michigan
Henry Ford Health System
RECRUITING
Detroit
Foundation for Vision Research and Retina Specialists of Michigan, P.C.
RECRUITING
Grand Rapids
Vitreo-Retinal Associates
RECRUITING
Grand Rapids
Minnesota
Retina Center, PA DBA Retina Center of Minnesota
RECRUITING
Minneapolis
Mayo Clinic
RECRUITING
Rochester
Missouri
The Curators of the University of Missouri
RECRUITING
Columbia
Retina Research Institute, LLC
RECRUITING
St Louis
Washington University Ophthalmology
RECRUITING
St Louis
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
New York
Retina-Vitreous Surgeons of Central NY, PC
RECRUITING
Liverpool
MaculaCare
RECRUITING
New York
Retina Associates of Western NY, P.C.
RECRUITING
Rochester
Pamela Weber, MD/Island Retina
RECRUITING
Shirley
Ohio
The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine
RECRUITING
Cleveland
Oklahoma
Dean A. McGee Eye Institute
RECRUITING
Oklahoma City
Oregon
Verum Research LLC
RECRUITING
Eugene
Oregon Health & Science University
RECRUITING
Portland
Retina Consultants, LLC
RECRUITING
Salem
Cascade Medical Research Institute, LLC
RECRUITING
Springfield
Pennsylvania
Retina-Vitreous Consultants, Inc.
RECRUITING
Monroeville
Pittsburg Clinical Trial Consortium
RECRUITING
Sewickley
Tennessee
Southeastern Retina Associates, P.C.
RECRUITING
Knoxville
Vanderbilt Eye Institute
RECRUITING
Nashville
Texas
Austin Research Center for Retina
RECRUITING
Austin
Austin Retina Associates
RECRUITING
Austin
Retina Consultants of Texas
RECRUITING
Beaumont
Retina Consultants of Texas, PA
RECRUITING
Bellaire
Baylor College of Medicine, Baylor Eye Physicians and Surgeons
RECRUITING
Houston
Texas Retina Associates
RECRUITING
Lubbock
Retinal Consultants of San Antonio
RECRUITING
San Antonio
Washington
University of Washington
RECRUITING
Seattle
Wisconsin
Gunderson Health System
RECRUITING
La Crosse
Eye Clinic of Wisconsin
RECRUITING
Wausau
Contact Information
Primary
Adam R Glassman, MS
drcrnet@jaeb.org
813-975-8690
Backup
Emily Chew, MD
Time Frame
Start Date: 2021-03-05
Estimated Completion Date: 2029-12
Participants
Target number of participants: 560
Treatments
Experimental: Fenofibrate 160-mg
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Collaborators: Juvenile Diabetes Research Foundation, The Leona M. and Harry B. Helmsley Charitable Trust, Roche Pharma AG, National Institutes of Health (NIH), National Eye Institute (NEI)
Leads: Jaeb Center for Health Research

This content was sourced from clinicaltrials.gov