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RECRUITINGPhase 3INTERVENTIONAL

Fenofibrate for Prevention of DR Worsening

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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.

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.

Locations (20)

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