Fenofibrate for Prevention of DR Worsening
Launched by JAEB CENTER FOR HEALTH RESEARCH · Dec 3, 2020
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the use of a medication called fenofibrate to see if it can help prevent worsening diabetic retinopathy (DR) in people with mild to moderately severe non-proliferative diabetic retinopathy. DR is a common eye condition that can occur in people with diabetes and can lead to vision loss if not managed properly. The trial will last for six years, and researchers want to find out if fenofibrate can slow down the progression of DR and reduce the need for more invasive treatments. They will also explore whether eye doctors can work together with primary care providers to safely prescribe this medication.
To participate in the study, individuals must be between 18 and 80 years old, have either type 1 or type 2 diabetes, and have at least one eye showing signs of mild to moderately severe non-proliferative diabetic retinopathy. Participants will be closely monitored during the trial, which includes regular check-ups to assess their eye health and manage their diabetes. It's important to note that individuals with certain eye conditions or serious kidney issues may not be eligible for this study. If successful, this research could lead to new ways to help many people manage their eye health more effectively, potentially preventing serious vision problems.
Gender
ALL
Eligibility criteria
- • Key Inclusion Criteria
- • 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)
- • Key Exclusion Criteria
- Eye-level exclusion criteria (the eye is ineligible if any of the following is met):
- • Current CI-DME based on clinical exam or OCT central subfield thickness (CST)
- • 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
About Jaeb Center For Health Research
The Jaeb Center for Health Research is a leading nonprofit organization dedicated to advancing medical research through innovative clinical trials and data analysis. With a strong emphasis on improving patient outcomes, the Center collaborates with healthcare professionals and institutions to conduct rigorous studies across various therapeutic areas, particularly in ophthalmology and diabetes. By leveraging cutting-edge methodologies and a commitment to ethical research practices, the Jaeb Center strives to enhance the understanding of disease mechanisms and develop effective treatment options, ultimately contributing to the improvement of public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Rochester, Minnesota, United States
Chicago, Illinois, United States
Seattle, Washington, United States
Boston, Massachusetts, United States
Portland, Oregon, United States
Austin, Texas, United States
Loma Linda, California, United States
Oklahoma City, Oklahoma, United States
Fort Myers, Florida, United States
New York, New York, United States
Sarasota, Florida, United States
Augusta, Georgia, United States
Baltimore, Maryland, United States
Lubbock, Texas, United States
Nashville, Tennessee, United States
Lakeland, Florida, United States
Detroit, Michigan, United States
San Antonio, Texas, United States
Chapel Hill, North Carolina, United States
Jacksonville, Florida, United States
Indianapolis, Indiana, United States
Marietta, Georgia, United States
Sandy Springs, Georgia, United States
Grand Rapids, Michigan, United States
La Crosse, Wisconsin, United States
Pinellas Park, Florida, United States
Ayer, Massachusetts, United States
Boston, Massachusetts, United States
Overland Park, Kansas, United States
Springfield, Oregon, United States
Austin, Texas, United States
Salem, Oregon, United States
Glendale, California, United States
Huntington Beach, California, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Sarasota, Florida, United States
Wesley Chapel, Florida, United States
Oak Park, Illinois, United States
New Albany, Indiana, United States
Hiawatha, Iowa, United States
West Des Moines, Iowa, United States
West Monroe, Louisiana, United States
Minneapolis, Minnesota, United States
Columbia, Missouri, United States
Saint Louis, Missouri, United States
Liverpool, New York, United States
Rochester, New York, United States
Shirley, New York, United States
Eugene, Oregon, United States
Monroeville, Pennsylvania, United States
Knoxville, Tennessee, United States
Bellaire, Texas, United States
Houston, Texas, United States
Sacramento, California, United States
Cleveland, Ohio, United States
San Francisco, California, United States
Beaumont, Texas, United States
Grand Rapids, Michigan, United States
Sewickley, Pennsylvania, United States
Wausau, Wisconsin, United States
Pasadena, California, United States
Patients applied
Trial Officials
Emily Y Chew, MD
Study Chair
National Institutes of Health (NIH)
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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