ClinConnect ClinConnect Logo
Search / Trial NCT04661358

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

Fenofibrate Non Proliferative Diabetic Retinopathy

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.

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

0 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

Similar Trials