Clinical trial NCT04661358: Fenofibrate for Prevention of DR Worsening
Official title: A Randomized Clinical Trial Evaluating Fenofibrate for Prevention of Diabetic Retinopathy Worsening
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Diabetic Retinopathy
Keywords: Fenofibrate
non-proliferative diabetic retinopathy
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Eye Institute (NEI)
name: Juvenile Diabetes Research Foundation
name: Roche Pharma AG
name: The Leona M. and Harry B. Helmsley Charitable Trust
First posted: 2020-12-10
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-masked, placebo-controlled clinical trial
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Worsening of diabetic retinopathy
timeFrame: 6- years
Secondary outcomes:
measure: Intraocular procedure undertaken to treat diabetic retinopathy or diabetic macular edema including PRP, intraocular anti-VEGF, corticosteroid, focal/grid laser or vitrectomy
timeFrame: 6 years
measure: Development of CI-DME
timeFrame: 6 years
measure: Development of center-involved diabetic macular edema with vision loss
timeFrame: 6 years
measure: Visual acuity loss from any cause
timeFrame: 6 years
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Kent W. Small, MD, AMC
state: California
city: Huntington Beach
country: United States
facility: Salehi Retina Institute Inc.
state: California
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Sacramento
country: United States
facility: Regents of the University of California, Davis, DBA University of California, Davis
state: California
city: San Francisco
country: United States
facility: The Regents of the University of California, San Francisco
state: California
city: Fort Myers
country: United States
facility: National Ophthalmic Research Institute
state: Florida
city: Jacksonville
country: United States
facility: University of Florida- Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
state: Florida
city: Lakeland
country: United States
facility: Florida Retina Consultants
state: Florida
city: Orlando
country: United States
facility: Florida Retina Institute, James A. Staman, MD, PA- Orlando
state: Florida
city: Pinellas Park
country: United States
facility: Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
state: Florida
city: Sarasota
country: United States
facility: Retina Vitreous Consultants, LLP
state: Florida
city: Sarasota
country: United States
facility: Sarasota Retina Institute
state: Florida
city: Wesley Chapel
country: United States
facility: SEASHORE RETINA LLC DBA Retina Specialists of Tampa
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center, P.C.
state: Georgia
city: Marietta
country: United States
facility: Marietta Eye Clinic
state: Georgia
city: Sandy Springs
country: United States
facility: Thomas Eye Group
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Oak Park
country: United States
facility: Illinois Retina Associates SC - Oak Park Site
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Eye Institute
state: Indiana
city: New Albany
country: United States
facility: John Kenyon American Eye Institute, LLC
state: Indiana
city: Hiawatha
country: United States
facility: Wolfe Eye Clinic-Cedar Rapids
state: Iowa
city: West Des Moines
country: United States
facility: Wolfe Clinic, P.C.- West Des Moines
state: Iowa
city: Overland Park
country: United States
facility: Mid-America Retina Consultants, P.A.
state: Kansas
city: West Monroe
country: United States
facility: Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
state: Louisiana
city: Baltimore
country: United States
facility: Elman Retina Group, P.A.
state: Maryland
city: Ayer
country: United States
facility: Valley Eye Physicians and Surgeons
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center Corporation
state: Massachusetts
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Grand Rapids
country: United States
facility: Foundation for Vision Research and Retina Specialists of Michigan, P.C.
state: Michigan
city: Grand Rapids
country: United States
facility: Vitreo-Retinal Associates
state: Michigan
city: Minneapolis
country: United States
facility: Retina Center, PA DBA Retina Center of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Columbia
country: United States
facility: The Curators of the University of Missouri
state: Missouri
city: Saint Louis
country: United States
facility: Retina Research Institute, LLC
state: Missouri
city: Liverpool
country: United States
facility: Retina-Vitreous Surgeons of Central NY, PC
state: New York
city: New York
country: United States
facility: MaculaCare
state: New York
city: Rochester
country: United States
facility: Retina Associates of Western NY, P.C.
state: New York
city: Shirley
country: United States
facility: Pamela Weber, MD/Island Retina
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine
state: Ohio
city: Oklahoma City
country: United States
facility: Dean A. McGee Eye Institute
state: Oklahoma
city: Eugene
country: United States
facility: Verum Research LLC
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Salem
country: United States
facility: Retina Consultants, LLC
state: Oregon
city: Springfield
country: United States
facility: Cascade Medical Research Institute, LLC
state: Oregon
city: Monroeville
country: United States
facility: Retina-Vitreous Consultants, Inc.
state: Pennsylvania
city: Sewickley
country: United States
facility: Pittsburg Clinical Trial Consortium
state: Pennsylvania
city: Knoxville
country: United States
facility: Southeastern Retina Associates, P.C.
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Eye Institute
state: Tennessee
city: Austin
country: United States
facility: Austin Research Center for Retina
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Bellaire
country: United States
facility: Retina Consultants of Texas, PA
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine, Baylor Eye Physicians and Surgeons
state: Texas
city: Lubbock
country: United States
facility: Texas Retina Associates
state: Texas
city: San Antonio
country: United States
facility: Retinal Consultants of San Antonio
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: La Crosse
country: United States
facility: Gunderson Health System
state: Wisconsin
city: Wausau
country: United States
facility: Eye Clinic of Wisconsin
state: Wisconsin
Study officials:
affiliation: National Institutes of Health (NIH)
name: Emily Y Chew, MD
role: STUDY_CHAIR
References: