Actively Recruiting
Fenofibrate for Prevention of DR Worsening
Led by Jaeb Center for Health Research · Updated on 2025-11-13
560
Participants Needed
66
Research Sites
456 weeks
Total Duration
On this page
Sponsors
J
Jaeb Center for Health Research
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Fenofibrate for Prevention of DR Worsening
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and under 80 years
- Diagnosis of type 1 or type 2 diabetes
- At least one eye with mild to moderately severe non-proliferative diabetic retinopathy (ETDRS level 35 to 47) confirmed by central Reading Center grading
- Best-corrected visual acuity letter score of 74 or higher (approximate Snellen equivalent 20/32 or better) in the eligible eye
- If only one eye is eligible, the other eye must have diabetic retinopathy severity level 20 (microaneurysms only)
You will not qualify if you...
- Presence of center-involved diabetic macular edema (CI-DME) based on clinical exam or OCT central subfield thickness above specified thresholds
- Prior treatment for diabetic macular edema or diabetic retinopathy except focal/grid laser more than 12 months ago
- History of intraocular anti-VEGF or corticosteroid treatment within the past year
- Decreased kidney function requiring dialysis or eGFR less than 45 mL/min/1.73 m2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 66 locations
1
Kent W. Small, MD, AMC
Glendale, California, United States, 91203-1971
Actively Recruiting
2
Salehi Retina Institute Inc.
Huntington Beach, California, United States, 92647-8693
Actively Recruiting
3
Loma Linda University
Loma Linda, California, United States, 92354
Actively Recruiting
4
UCLA Stein Eye Institute
Pasadena, California, United States, 91103
Actively Recruiting
5
Regents of the University of California, Davis, DBA University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
6
The Regents of the University of California, San Francisco
San Francisco, California, United States, 94110
Actively Recruiting
7
National Ophthalmic Research Institute
Fort Myers, Florida, United States, 33912
Actively Recruiting
8
University of Florida- Jacksonville
Jacksonville, Florida, United States, 32209
Actively Recruiting
9
Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
Jacksonville, Florida, United States, 32216
Actively Recruiting
10
Florida Retina Consultants
Lakeland, Florida, United States, 33805
Actively Recruiting
11
Florida Retina Institute, James A. Staman, MD, PA- Orlando
Orlando, Florida, United States, 32806-1101
Actively Recruiting
12
Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
Pinellas Park, Florida, United States, 33782
Actively Recruiting
13
Retina Vitreous Consultants, LLP
Sarasota, Florida, United States, 34233-1261
Actively Recruiting
14
Sarasota Retina Institute
Sarasota, Florida, United States, 34239
Actively Recruiting
15
SEASHORE RETINA LLC DBA Retina Specialists of Tampa
Wesley Chapel, Florida, United States, 33544
Actively Recruiting
16
Southeast Retina Center, P.C.
Augusta, Georgia, United States, 30909
Actively Recruiting
17
Marietta Eye Clinic
Marietta, Georgia, United States, 30060
Actively Recruiting
18
Thomas Eye Group
Sandy Springs, Georgia, United States, 30328
Actively Recruiting
19
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
20
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
21
UIC - Dept of Ophthalmology & Visual Sciences
Chicago, Illinois, United States, 60612
Actively Recruiting
22
Illinois Retina Associates SC - Oak Park Site
Oak Park, Illinois, United States, 60304
Actively Recruiting
23
Midwest Eye Institute
Indianapolis, Indiana, United States, 46290
Actively Recruiting
24
John Kenyon American Eye Institute, LLC
New Albany, Indiana, United States, 47150
Actively Recruiting
25
Wolfe Eye Clinic-Cedar Rapids
Hiawatha, Iowa, United States, 52233
Actively Recruiting
26
Wolfe Clinic, P.C.- West Des Moines
West Des Moines, Iowa, United States, 50266-7705
Actively Recruiting
27
Mid-America Retina Consultants, P.A.
Overland Park, Kansas, United States, 66211
Actively Recruiting
28
University of Kansas Medical Center Research Institute, Inc.
Prairie Village, Kansas, United States, 66208
Actively Recruiting
29
Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
West Monroe, Louisiana, United States, 71291-4452
Actively Recruiting
30
Elman Retina Group, P.A.
Baltimore, Maryland, United States, 21237
Actively Recruiting
31
Valley Eye Physicians and Surgeons
Ayer, Massachusetts, United States, 01432
Actively Recruiting
32
Boston Medical Center Corporation
Boston, Massachusetts, United States, 02118
Actively Recruiting
33
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
34
Henry Ford Health System
Detroit, Michigan, United States, 48202-2689
Actively Recruiting
35
Foundation for Vision Research and Retina Specialists of Michigan, P.C.
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
36
Vitreo-Retinal Associates
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
37
Retina Center, PA DBA Retina Center of Minnesota
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
38
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
39
The Curators of the University of Missouri
Columbia, Missouri, United States, 65201-5276
Actively Recruiting
40
Washington University Ophthalmology
St Louis, Missouri, United States, 63110
Actively Recruiting
41
Retina Research Institute, LLC
St Louis, Missouri, United States, 63128-1729
Actively Recruiting
42
Retina-Vitreous Surgeons of Central NY, PC
Liverpool, New York, United States, 13088
Actively Recruiting
43
MaculaCare
New York, New York, United States, 10021
Actively Recruiting
44
Retina Associates of Western NY, P.C.
Rochester, New York, United States, 14620-4655
Actively Recruiting
45
Pamela Weber, MD/Island Retina
Shirley, New York, United States, 11967
Actively Recruiting
46
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27517
Actively Recruiting
47
The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio, United States, 44120
Actively Recruiting
48
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
49
Verum Research LLC
Eugene, Oregon, United States, 97401
Actively Recruiting
50
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
51
Retina Consultants, LLC
Salem, Oregon, United States, 97302
Actively Recruiting
52
Cascade Medical Research Institute, LLC
Springfield, Oregon, United States, 97477
Actively Recruiting
53
Retina-Vitreous Consultants, Inc.
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
54
Pittsburg Clinical Trial Consortium
Sewickley, Pennsylvania, United States, 15143
Actively Recruiting
55
Southeastern Retina Associates, P.C.
Knoxville, Tennessee, United States, 37922
Actively Recruiting
56
Vanderbilt Eye Institute
Nashville, Tennessee, United States, 37232
Actively Recruiting
57
Austin Research Center for Retina
Austin, Texas, United States, 78705
Actively Recruiting
58
Austin Retina Associates
Austin, Texas, United States, 78705
Actively Recruiting
59
Retina Consultants of Texas
Beaumont, Texas, United States, 77707
Actively Recruiting
60
Retina Consultants of Texas, PA
Bellaire, Texas, United States, 77401
Actively Recruiting
61
Baylor College of Medicine, Baylor Eye Physicians and Surgeons
Houston, Texas, United States, 77030-4101
Actively Recruiting
62
Texas Retina Associates
Lubbock, Texas, United States, 79424
Actively Recruiting
63
Retinal Consultants of San Antonio
San Antonio, Texas, United States, 78240
Actively Recruiting
64
University of Washington
Seattle, Washington, United States, 98104
Actively Recruiting
65
Gunderson Health System
La Crosse, Wisconsin, United States, 54601
Actively Recruiting
66
Eye Clinic of Wisconsin
Wausau, Wisconsin, United States, 54403
Actively Recruiting
Research Team
A
Adam R Glassman, MS
CONTACT
E
Emily Chew, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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