Fenofibrate for Prevention of DR Worsening (Protocol AF)

March 25, 2024 updated by: Jaeb Center for Health Research

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

560

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Emily Chew, MD

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91203-1971
        • Recruiting
        • Kent W. Small, MD, AMC
        • Contact:
      • Huntington Beach, California, United States, 92647-8693
        • Recruiting
        • Salehi Retina Institute Inc.
        • Contact:
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University
        • Contact:
      • Sacramento, California, United States, 95817
        • Recruiting
        • Regents of the University of California, Davis, DBA University of California, Davis
        • Contact:
      • San Francisco, California, United States, 94110
        • Recruiting
        • The Regents of the University of California, San Francisco
        • Contact:
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Recruiting
        • National Ophthalmic Research Institute
        • Contact:
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
        • Contact:
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • University of Florida- Jacksonville
        • Contact:
      • Lakeland, Florida, United States, 33805
        • Recruiting
        • Florida Retina Consultants
        • Contact:
      • Orlando, Florida, United States, 32806-1101
        • Recruiting
        • Florida Retina Institute, James A. Staman, MD, PA- Orlando
        • Contact:
      • Pinellas Park, Florida, United States, 33782
        • Recruiting
        • Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
        • Contact:
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Retina Institute
        • Contact:
      • Sarasota, Florida, United States, 34233-1261
        • Recruiting
        • Retina Vitreous Consultants, LLP
        • Contact:
      • Wesley Chapel, Florida, United States, 33544
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Recruiting
        • Southeast Retina Center, P.C.
        • Contact:
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Marietta Eye Clinic
        • Contact:
      • Sandy Springs, Georgia, United States, 30328
        • Recruiting
        • Thomas Eye Group
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
      • Chicago, Illinois, United States, 60611
      • Oak Park, Illinois, United States, 60304
        • Recruiting
        • Illinois Retina Associates SC - Oak Park Site
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Recruiting
        • Midwest Eye Institute
        • Contact:
      • New Albany, Indiana, United States, 47150
        • Recruiting
        • John Kenyon American Eye Institute, LLC
        • Contact:
    • Iowa
      • Hiawatha, Iowa, United States, 52233
        • Recruiting
        • Wolfe Eye Clinic-Cedar Rapids
        • Contact:
      • West Des Moines, Iowa, United States, 50266-7705
        • Recruiting
        • Wolfe Clinic, P.C.- West Des Moines
        • Contact:
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • Mid-America Retina Consultants, P.A.
        • Contact:
    • Louisiana
      • West Monroe, Louisiana, United States, 71291-4452
        • Recruiting
        • Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Recruiting
        • Elman Retina Group, P.A.
        • Contact:
    • Massachusetts
      • Ayer, Massachusetts, United States, 01432
      • Boston, Massachusetts, United States, 02215
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center Corporation
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202-2689
        • Recruiting
        • Henry Ford Health System
        • Contact:
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • Vitreo-Retinal Associates
        • Contact:
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • Foundation for Vision Research and Retina Specialists of Michigan, P.C.
        • Contact:
          • Thomas M. Aaberg, MD
          • Phone Number: 616-954-2020
          • Email: holly@fvr.org
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Recruiting
        • Retina Center, PA DBA Retina Center of Minnesota
        • Contact:
      • Rochester, Minnesota, United States, 55905
    • Missouri
      • Columbia, Missouri, United States, 65201-5276
        • Recruiting
        • The Curators of the University of Missouri
        • Contact:
      • Saint Louis, Missouri, United States, 63128-1729
        • Recruiting
        • Retina Research Institute, LLC
        • Contact:
    • New York
      • Liverpool, New York, United States, 13088
        • Recruiting
        • Retina-Vitreous Surgeons of Central NY, PC
        • Contact:
      • New York, New York, United States, 10021
        • Recruiting
        • MaculaCare
        • Contact:
      • Rochester, New York, United States, 14620-4655
      • Shirley, New York, United States, 11967
        • Recruiting
        • Pamela Weber, MD/Island Retina
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • Recruiting
        • University of North Carolina at Chapel Hill
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44120
        • Recruiting
        • The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine
        • Contact:
          • Aleksandra V. Rachitskaya, MD
          • Phone Number: 216-445-9519
          • Email: contit@ccf.org
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • Dean A. McGee Eye Institute
        • Contact:
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Verum Research LLC
        • Contact:
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
      • Salem, Oregon, United States, 97302
        • Recruiting
        • Retina Consultants, LLC
        • Contact:
      • Springfield, Oregon, United States, 97477
    • Pennsylvania
      • Monroeville, Pennsylvania, United States, 15146
      • Sewickley, Pennsylvania, United States, 15143
        • Recruiting
        • Pittsburg Clinical Trial Consortium
        • Contact:
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • Recruiting
        • Southeastern Retina Associates, P.C.
        • Contact:
      • Nashville, Tennessee, United States, 37232
    • Texas
      • Austin, Texas, United States, 78705
      • Austin, Texas, United States, 78705
        • Recruiting
        • Austin Retina Associates
        • Contact:
      • Bellaire, Texas, United States, 77401
      • Houston, Texas, United States, 77030-4101
        • Recruiting
        • Baylor College of Medicine, Baylor Eye Physicians and Surgeons
        • Contact:
      • Lubbock, Texas, United States, 79424
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Retinal Consultants of San Antonio
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • University of Washington
        • Contact:
          • Kasra Rezaei, MD
          • Phone Number: 206-543-7250
          • Email: Simona@uw.edu
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: 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.
Experimental: Fenofibrate 160-mg
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Worsening of diabetic retinopathy
Time Frame: 6- years

Defined as

  • 2 or more step worsening on Early Treatment Diabetic Retinopathy Study (ETDRS) diabetic retinopathy severity on fundus photographs.
  • Development of neovascularization within the 7-modified ETDRS fields on fluorescein angiography.
  • Intraocular procedure undertaken to treat diabetic retinopathy including panretinal photocoagulation, intraocular anti-vascular endothelial growth factor, corticosteroid, or vitrectomy.
6- years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular procedure undertaken to treat diabetic retinopathy or diabetic macular edema including PRP, intraocular anti-VEGF, corticosteroid, focal/grid laser or vitrectomy
Time Frame: 6 years
6 years
Development of CI-DME
Time Frame: 6 years
Defined as, either 1) at least a 10% increase in OCT central subfield thickness from baseline, OCT central subfield thickness greater than sex and machine-specific threshold values (Zeiss Cirrus: CST ≥290 µm in women or ≥ 305 µm in men; Heidelberg Spectralis: CST ≥305 µm in women or ≥320 µm in men), and Investigator determination that thickening cannot be attributed to any cause other than CI-DME, or 2)Intraocular DME treatment including focal/grid laser, intraocular anti-VEGF, intraocular corticosteroid, or vitrectomy
6 years
Development of center-involved diabetic macular edema with vision loss
Time Frame: 6 years
Defined as either 1) an increase in OCT central subfield thickness of 10% or more from baseline, OCT central subfield thickness greater than sex and machine-specific threshold values (Zeiss Cirrus: CST ≥290 µm in women or ≥ 305 µm in men; Heidelberg Spectralis: CST ≥305 µm in women or ≥320 µm in men), investigator determination that thickening cannot be attributed to any cause other than DME, and a decrease in visual acuity from baseline of 10 or more letters at a single visit or 5 to 9 letters at 2 consecutive visits at least 21 days apart with vision loss presumed to be from DME, intraocular DME or 2) treatment including focal/grid laser, anti-VEGF, corticosteroid injection, or vitrectomy
6 years
Visual acuity loss from any cause
Time Frame: 6 years
Defined as a decrease in visual acuity from baseline of 10 or more letters at a single visit or a 5 to 9-letter decrease at 2 consecutive visits at least 21 days apart regardless of whether vision loss is presumed to be from DME or any other cause
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaeb Center for Health Research

Collaborators

Juvenile Diabetes Research Foundation
Roche Pharma AG
National Eye Institute (NEI)
National Institutes of Health (NIH)
The Leona M. and Harry B. Helmsley Charitable Trust

Investigators

  • Study Chair: Emily Y Chew, MD, National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2021

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

December 3, 2020

First Submitted That Met QC Criteria

December 3, 2020

First Posted (Actual)

December 10, 2020

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRCR.net Protocol AF
  • U10EY014231 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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