Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
560 participants
INTERVENTIONAL
2021-03-05
2029-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Fenofibrate 160-mg
Fenofibrate
Participants begin with a dose of either 160mg or 54mg fenofibrate, based on eGFR value at screening, taken once daily with food. The dose may be adjusted during follow-up based on protocol guidelines.
Placebo
Placebo
Participants begin with a dose of either 160mg or 54mg placebo, based on eGFR value at screening, taken once daily with food. The dose may be adjusted during follow-up based on protocol guidelines.
Interventions
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Fenofibrate
Participants begin with a dose of either 160mg or 54mg fenofibrate, based on eGFR value at screening, taken once daily with food. The dose may be adjusted during follow-up based on protocol guidelines.
Placebo
Participants begin with a dose of either 160mg or 54mg placebo, based on eGFR value at screening, taken once daily with food. The dose may be adjusted during follow-up based on protocol guidelines.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* Zeiss Cirrus: CST ≥290 µm in women or ≥ 305 µm in men
* Heidelberg Spectralis: CST ≥305 µm in women or ≥320 µm in men
* Any prior treatment for DME or DR, other than focal/grid laser. If the eye has a history of focal/grid laser, it must be at least 12 months prior.
* History of intraocular anti-VEGF or corticosteroid treatment within the prior year for any indication
Participant-level exclusion criterion (the participant is ineligible if the following criterion is met):
• Decreased renal function, defined as requiring dialysis or central laboratory eGFR value \< 45 mL/min/1.73 m2
18 Years
80 Years
ALL
No
Sponsors
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Jaeb Center for Health Research
OTHER
National Institutes of Health (NIH)
NIH
National Eye Institute (NEI)
NIH
Juvenile Diabetes Research Foundation
OTHER
Roche Pharma AG
INDUSTRY
The Leona M. and Harry B. Helmsley Charitable Trust
OTHER
Responsible Party
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Principal Investigators
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Emily Y Chew, MD
Role: STUDY_CHAIR
National Institutes of Health (NIH)
Locations
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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
Florida Retina Institute, James A. Staman, MD, PA- Orlando
Orlando, Florida, United States
Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
Pinellas Park, Florida, United States
Retina Vitreous Consultants, LLP
Sarasota, Florida, United States
Sarasota Retina Institute
Sarasota, Florida, United States
SEASHORE RETINA LLC DBA Retina Specialists of Tampa
Wesley Chapel, Florida, United States
Southeast Retina Center, P.C.
Augusta, Georgia, United States
Marietta Eye Clinic
Marietta, Georgia, United States
Thomas Eye Group
Sandy Springs, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
UIC - Dept of Ophthalmology & Visual Sciences
Chicago, Illinois, United States
Illinois Retina Associates SC - Oak Park Site
Oak Park, Illinois, United States
Midwest Eye Institute
Indianapolis, Indiana, United States
John Kenyon American Eye Institute, LLC
New Albany, Indiana, United States
Wolfe Eye Clinic-Cedar Rapids
Hiawatha, Iowa, United States
Wolfe Clinic, P.C.- West Des Moines
West Des Moines, Iowa, United States
Mid-America Retina Consultants, P.A.
Overland Park, Kansas, United States
University of Kansas Medical Center Research Institute, Inc.
Prairie Village, Kansas, United States
Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
West Monroe, Louisiana, United States
Elman Retina Group, P.A.
Baltimore, Maryland, United States
Valley Eye Physicians and Surgeons
Ayer, Massachusetts, United States
Boston Medical Center Corporation
Boston, Massachusetts, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Foundation for Vision Research and Retina Specialists of Michigan, P.C.
Grand Rapids, Michigan, United States
Vitreo-Retinal Associates
Grand Rapids, Michigan, United States
Retina Center, PA DBA Retina Center of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
The Curators of the University of Missouri
Columbia, Missouri, United States
Washington University Ophthalmology
St Louis, Missouri, United States
Retina Research Institute, LLC
St Louis, Missouri, United States
Retina-Vitreous Surgeons of Central NY, PC
Liverpool, New York, United States
MaculaCare
New York, New York, United States
Retina Associates of Western NY, P.C.
Rochester, New York, United States
Pamela Weber, MD/Island Retina
Shirley, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio, United States
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States
Verum Research LLC
Eugene, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Retina Consultants, LLC
Salem, Oregon, United States
Cascade Medical Research Institute, LLC
Springfield, Oregon, United States
Retina-Vitreous Consultants, Inc.
Monroeville, Pennsylvania, United States
Pittsburg Clinical Trial Consortium
Sewickley, Pennsylvania, United States
Southeastern Retina Associates, P.C.
Knoxville, Tennessee, United States
Vanderbilt Eye Institute
Nashville, Tennessee, United States
Austin Research Center for Retina
Austin, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Retina Consultants of Texas
Beaumont, Texas, United States
Retina Consultants of Texas, PA
Bellaire, Texas, United States
Baylor College of Medicine, Baylor Eye Physicians and Surgeons
Houston, Texas, United States
Texas Retina Associates
Lubbock, Texas, United States
Retinal Consultants of San Antonio
San Antonio, Texas, United States
University of Washington
Seattle, Washington, United States
Gunderson Health System
La Crosse, Wisconsin, United States
Eye Clinic of Wisconsin
Wausau, Wisconsin, United States
Countries
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Central Contacts
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Emily Chew, MD
Role: CONTACT
Facility Contacts
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Other Identifiers
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DRCR.net Protocol AF
Identifier Type: -
Identifier Source: org_study_id
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