PROMINENT-Eye Ancillary Study (Protocol AD)

Last updated: August 27, 2020
Sponsor: Jaeb Center for Health Research
Overall Status: Terminated

Phase

3

Condition

Diabetic Macular Edema

Diabetic Retinopathy

Retina

Treatment

N/A

Clinical Study ID

NCT03345901
DRCR.net Protocol AD
  • Ages > 18
  • All Genders

Study Summary

Despite improved glycemic and systemic control for many patients with diabetes, over the past several decades, diabetic retinopathy (DR) develops and progresses in a large proportion of patients, and visual loss from diabetic eye complications continues to be a leading cause of blindness in the US and other developed countries worldwide. Thus, even a modest ability to prevent DR onset or to slow DR worsening might substantially reduce the number of patients at risk for diabetes-related vision loss worldwide. Widespread use of an oral agent effective at reducing worsening of DR might also decrease the numbers of patients who undergo treatment for DR and diabetic macular edema (DME) and who are consequently at risk for side effects that adversely affect visual function. Two major studies of fenofibrate, the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) and The Action to Control Cardiovascular Risk in Diabetes (ACCORD)-eye study, have demonstrated clinically important reduction in progression of retinopathy in patients with diabetes assigned to fibrate compared with placebo. However, despite the positive clinical trial results, fenofibrate has not gained wide acceptance as a preventive agent by either ophthalmologists or primary diabetes care providers. Thus, it is important to provide further evidence demonstrating whether or not selectively increasing peroxisome proliferator-activated receptor alpha (PPARα) activity reduces progression of retinopathy in patients with diabetes and non-proliferative diabetic retinopathy at baseline. Pemafibrate is a more potent and selective PPARα modulator than fenofibrate. Its efficacy is currently being evaluated in the Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT) study for prevention of cardiovascular events in patients with type 2 diabetes. Given the large study cohort with a substantial proportion likely to have DR and the multi-year duration of the PROMINENT trial, this study represents a unique opportunity to assess effects of chronic PPARα activation through pemafibrate therapy on DR outcomes.

Primary Study Objective: To assess whether treatment with pemafibrate (0.2 mg orally BID) compared with placebo reduces the hazard rate of diabetic retinopathy worsening in adults with type 2 diabetes and diabetic retinopathy without neovascularization in at least one eye who are participating in the parent PROMINENT trial.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Already randomized at US or Canadian sites in the PROMINENT study

  • Ability to cooperate with dilated ophthalmic examination and imaging procedures

  • At least one eye meets the following study eye inclusion criteria:

  1. Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severitylevel between 20 and 53 (minimal to severe non-proliferative diabetic retinopathy (NPDR)), inclusive, on color fundus photographs confirmed by central ReadingCenter grading.

Exclusion

Exclusion Criteria:

  • Study eye exclusion criteria are: a. Neovascularization present. b. Current central-involved diabetic macular edema (DMEbased on optical coherence tomography (OCT) central subfield thickness (CST) i. ZeissCirrus: CST ≥ 290µm in women or ≥ 305µm in men ii. Heidelberg Spectralis: CST ≥ 305µmin women or ≥ 320µm in men c. Known major non-diabetic intraocular pathology that inthe opinion of the investigator would substantially and adversely affect visual acuityor lead to ocular neovascularization during the course of the study d. Anticipatedneed for intravitreous anti-vascular endothelial growth factor (VEGF), intravitreouscorticosteroid, or pan-retinal photocoagulation (PRP) in the next 6 months followingrandomization e. History of intravitreous anti-VEGF or corticosteroid treatment withinthe prior year for any indication. f. History of intraocular surgery within prior 4 months or anticipated within the next 6 months following randomization g. Any history of PRP or vitrectomy h. History ofyttrium aluminum garnet (YAG) capsulotomy performed within 2 months prior to screeningi. Aphakia j. Known substantial media opacities that would preclude successful imaging

Study Design

Total Participants: 18
Study Start date:
January 15, 2018
Estimated Completion Date:
April 03, 2019

Connect with a study center

  • UBC/VCHA Eye Care Centre

    Vancouver, British Columbia V5Z 3N9
    Canada

    Site Not Available

  • University Health Network - Toronto Western Hospital

    Toronto, M5T 2S8
    Canada

    Site Not Available

  • Arizona Retina and Vitreous Consultants

    Phoenix, Arizona 85021
    United States

    Site Not Available

  • Retinal Diagnostic Center

    Campbell, California 95008
    United States

    Site Not Available

  • Macula & Retina Institute

    Glendale, California 91203
    United States

    Site Not Available

  • Atlantis Eye Care

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Loma Linda University Health Care, Department of Ophthalmology

    Loma Linda, California 92354
    United States

    Site Not Available

  • South Coast Retina Center

    Long Beach, California 90807
    United States

    Site Not Available

  • Northern California Retina Vitreous Associates

    Mountain View, California 94040
    United States

    Site Not Available

  • Retinal Consultants of Southern California Medical Group, Inc.

    Westlake Village, California 91361
    United States

    Site Not Available

  • National Ophthalmic Research Institute

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • University of Florida College of Med., Department of Ophthalmology, Jacksonville Health Science Cent

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Florida Retina Consultants

    Lakeland, Florida 33805
    United States

    Site Not Available

  • Retina Macula Specialists of Miami

    Miami, Florida 33126
    United States

    Site Not Available

  • Florida Retina Institute

    Orlando, Florida 32806
    United States

    Site Not Available

  • Southeast Eye Institute, P.A. dba Eye Associates of Pinellas

    Pinellas Park, Florida 33782
    United States

    Site Not Available

  • Sarasota Retina Institute

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Emory Eye Center

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Southeast Retina Center, P.C.

    Augusta, Georgia 30909
    United States

    Site Not Available

  • Thomas Eye Group

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Northwestern Medical Faculty Foundation

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Illinois at Chicago Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • NorthShore University HealthSystem

    Glenview, Illinois 60026
    United States

    Site Not Available

  • Illinois Retina Associates, S.C.

    Oak Park, Illinois 60304
    United States

    Site Not Available

  • John-Kenyon American Eye Institute

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Wolfe Eye Clinic

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Mid-America Retina Consultants, P.A.

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • Retina Associates, P.A.

    Shawnee Mission, Kansas 66204
    United States

    Site Not Available

  • Retina and Vitreous Associates of Kentucky

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • Eye Associates of Northeast Louisiana dba Haik Humble Eye Center

    West Monroe, Louisiana 71291-4452
    United States

    Site Not Available

  • Elman Retina Group, P.A.

    Baltimore, Maryland 21237
    United States

    Site Not Available

  • Wilmer Eye Institute at Johns Hopkins

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Valley Eye Physicians and Surgeons

    Ayer, Massachusetts 01432
    United States

    Site Not Available

  • Joslin Diabetes Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Kellogg Eye Center, University of Michigan

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • Henry Ford Health System, Dept of Ophthalmology and Eye Care Services

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Vitreo-Retinal Associates

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • Retina Center, PA

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • The Retina Institute

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • Eye Associates of New Mexico

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • MaculaCare

    New York, New York 10021
    United States

    Site Not Available

  • Retina Associates of Western New York

    Rochester, New York 14620
    United States

    Site Not Available

  • Retina-Vitreous Surgeons of Central New York, PC

    Syracuse, New York 13224
    United States

    Site Not Available

  • Western Carolina Clinical Research, LLC

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Kittner Eye Center

    Chapel Hill, North Carolina 27517-8923
    United States

    Site Not Available

  • Charlotte Eye, Ear, Nose and Throat Assoc., PA

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • Retina Vitreous Center

    Edmond, Oklahoma 73103
    United States

    Site Not Available

  • Dean A. McGee Eye Institute

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Retina Vitreous Consultants

    Monroeville, Pennsylvania 15146
    United States

    Site Not Available

  • Southeastern Retina Associates

    Chattanooga, Tennessee 37421
    United States

    Site Not Available

  • Southeastern Retina Associates, P.C.

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Retina Research Center

    Austin, Texas 78705
    United States

    Site Not Available

  • Robert E. Torti, MD, PA dba Retina Specialists

    DeSoto, Texas 75115-2011
    United States

    Site Not Available

  • Valley Retina Institute

    DeSoto, Texas 75115
    United States

    Site Not Available

  • Retina Center of Texas

    Grapevine, Texas 76051
    United States

    Site Not Available

  • Baylor Eye Physicians and Surgeons

    Houston, Texas 77030
    United States

    Site Not Available

  • Retina Consultants of Houston, PA

    Houston, Texas 77030
    United States

    Site Not Available

  • Valley Retina Institute

    McAllen, Texas 78503
    United States

    Site Not Available

  • Medical Center Ophthalmology Associates

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Retinal Consultants of San Antonio

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Retina Institute of Virginia

    Richmond, Virginia 23235
    United States

    Site Not Available

  • University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service

    Madison, Wisconsin 53705
    United States

    Site Not Available

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