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Fenofibrate for Prevention of DR 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.
Conditions:
🦠 Diabetic Retinopathy
🗓️ Study Start (Actual) 5 March 2021
🗓️ Primary Completion (Estimated) April 2029
✅ Study Completion (Estimated) April 2029
👥 Enrollment (Estimated) 560
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 Glendale, California, United States
📍 Huntington Beach, California, United States
📍 Loma Linda, California, United States
📍 Sacramento, California, United States
📍 San Francisco, California, United States
📍 Fort Myers, Florida, United States
📍 Jacksonville, Florida, United States
📍 Jacksonville, Florida, United States
📍 Lakeland, Florida, United States
📍 Orlando, Florida, United States
📍 Pinellas Park, Florida, United States
📍 Sarasota, Florida, United States
📍 Sarasota, Florida, United States
📍 Wesley Chapel, Florida, United States
📍 Augusta, Georgia, United States
📍 Marietta, Georgia, United States
📍 Sandy Springs, Georgia, United States
📍 Chicago, Illinois, United States
📍 Chicago, Illinois, United States
📍 Oak Park, Illinois, United States
📍 Indianapolis, Indiana, United States
📍 New Albany, Indiana, United States
📍 Hiawatha, Iowa, United States
📍 West Des Moines, Iowa, United States
📍 Overland Park, Kansas, United States
📍 West Monroe, Louisiana, United States
📍 Baltimore, Maryland, United States
📍 Ayer, Massachusetts, United States
📍 Boston, Massachusetts, United States
📍 Boston, Massachusetts, United States
📍 Detroit, Michigan, United States
📍 Grand Rapids, Michigan, United States
📍 Grand Rapids, Michigan, United States
📍 Minneapolis, Minnesota, United States
📍 Rochester, Minnesota, United States
📍 Columbia, Missouri, United States
📍 Saint Louis, Missouri, United States
📍 Liverpool, New York, United States
📍 New York, New York, United States
📍 Rochester, New York, United States
📍 Shirley, New York, United States
📍 Chapel Hill, North Carolina, United States
📍 Cleveland, Ohio, United States
📍 Oklahoma City, Oklahoma, United States
📍 Eugene, Oregon, United States
📍 Portland, Oregon, United States
📍 Salem, Oregon, United States
📍 Springfield, Oregon, United States
📍 Monroeville, Pennsylvania, United States
📍 Sewickley, Pennsylvania, United States
📍 Knoxville, Tennessee, United States
📍 Nashville, Tennessee, United States
📍 Austin, Texas, United States
📍 Austin, Texas, United States
📍 Bellaire, Texas, United States
📍 Houston, Texas, United States
📍 Lubbock, Texas, United States
📍 San Antonio, Texas, United States
📍 Seattle, Washington, United States
📍 La Crosse, Wisconsin, United States
More locations available...

📋 Eligibility Criteria

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
Ages Eligible for Study: 18 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

  • First Submitted 3 December 2020
  • First Submitted that Met QC Criteria 3 December 2020
  • First Posted 10 December 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 25 March 2024
  • Last Update Posted 27 March 2024
  • Last Verified March 2024
I'm interested ...!!