Fenofibrate for Prevention of DR Worsening

PHASE3RecruitingINTERVENTIONAL
Enrollment

560

Participants

Timeline

Start Date

March 5, 2021

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2029

Conditions
Diabetic Retinopathy
Interventions
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.

Trial Locations (64)

10021

RECRUITING

MaculaCare, New York

11967

RECRUITING

Pamela Weber, MD/Island Retina, Shirley

13088

RECRUITING

Retina-Vitreous Surgeons of Central NY, PC, Liverpool

15143

RECRUITING

Pittsburg Clinical Trial Consortium, Sewickley

15146

RECRUITING

Retina-Vitreous Consultants, Inc., Monroeville

21237

RECRUITING

Elman Retina Group, P.A., Baltimore

27517

RECRUITING

University of North Carolina at Chapel Hill, Chapel Hill

30060

RECRUITING

Marietta Eye Clinic, Marietta

30328

RECRUITING

Thomas Eye Group, Sandy Springs

30909

RECRUITING

Southeast Retina Center, P.C., Augusta

32209

RECRUITING

University of Florida- Jacksonville, Jacksonville

32216

RECRUITING

Florida Retina Institute, James A. Staman, MD, PA- Jacksonville, Jacksonville

33544

RECRUITING

SEASHORE RETINA LLC DBA Retina Specialists of Tampa, Wesley Chapel

33782

RECRUITING

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

33805

RECRUITING

Florida Retina Consultants, Lakeland

33912

RECRUITING

National Ophthalmic Research Institute, Fort Myers

34239

RECRUITING

Sarasota Retina Institute, Sarasota

37232

RECRUITING

Vanderbilt Eye Institute, Nashville

37922

RECRUITING

Southeastern Retina Associates, P.C., Knoxville

44120

RECRUITING

The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine, Cleveland

46290

RECRUITING

Midwest Eye Institute, Indianapolis

47150

RECRUITING

John Kenyon American Eye Institute, LLC, New Albany

49546

RECRUITING

Foundation for Vision Research and Retina Specialists of Michigan, P.C., Grand Rapids

RECRUITING

Vitreo-Retinal Associates, Grand Rapids

52233

RECRUITING

Wolfe Eye Clinic-Cedar Rapids, Hiawatha

54403

RECRUITING

Eye Clinic of Wisconsin, Wausau

54601

RECRUITING

Gunderson Health System, La Crosse

55404

RECRUITING

Retina Center, PA DBA Retina Center of Minnesota, Minneapolis

55905

RECRUITING

Mayo Clinic, Rochester

60304

RECRUITING

Illinois Retina Associates SC - Oak Park Site, Oak Park

60611

RECRUITING

Northwestern University, Chicago

60612

RECRUITING

Rush University Medical Center, Chicago

63110

RECRUITING

Washington University Ophthalmology, St Louis

66211

RECRUITING

Mid-America Retina Consultants, P.A., Overland Park

73104

RECRUITING

Dean A. McGee Eye Institute, Oklahoma City

77401

RECRUITING

Retina Consultants of Texas, PA, Bellaire

77707

RECRUITING

Retina Consultants of Texas, Beaumont

78240

RECRUITING

Retinal Consultants of San Antonio, San Antonio

78705

RECRUITING

Austin Research Center for Retina, Austin

RECRUITING

Austin Retina Associates, Austin

79424

RECRUITING

Texas Retina Associates, Lubbock

91103

RECRUITING

UCLA Stein Eye Institute, Pasadena

92354

RECRUITING

Loma Linda University, Loma Linda

94110

RECRUITING

The Regents of the University of California, San Francisco, San Francisco

95817

RECRUITING

Regents of the University of California, Davis, DBA University of California, Davis, Sacramento

97239

RECRUITING

Oregon Health & Science University, Portland

97302

RECRUITING

Retina Consultants, LLC, Salem

97401

RECRUITING

Verum Research LLC, Eugene

97477

RECRUITING

Cascade Medical Research Institute, LLC, Springfield

98104

RECRUITING

University of Washington, Seattle

91203-1971

RECRUITING

Kent W. Small, MD, AMC, Glendale

92647-8693

RECRUITING

Salehi Retina Institute Inc., Huntington Beach

32806-1101

RECRUITING

Florida Retina Institute, James A. Staman, MD, PA- Orlando, Orlando

34233-1261

RECRUITING

Retina Vitreous Consultants, LLP, Sarasota

50266-7705

RECRUITING

Wolfe Clinic, P.C.- West Des Moines, West Des Moines

71291-4452

RECRUITING

Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana, West Monroe

01432

RECRUITING

Valley Eye Physicians and Surgeons, Ayer

02118

RECRUITING

Boston Medical Center Corporation, Boston

02215

RECRUITING

Joslin Diabetes Center, Boston

48202-2689

RECRUITING

Henry Ford Health System, Detroit

65201-5276

RECRUITING

The Curators of the University of Missouri, Columbia

63128-1729

RECRUITING

Retina Research Institute, LLC, St Louis

14620-4655

RECRUITING

Retina Associates of Western NY, P.C., Rochester

77030-4101

RECRUITING

Baylor College of Medicine, Baylor Eye Physicians and Surgeons, Houston

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Eye Institute (NEI)

NIH

collaborator

Juvenile Diabetes Research Foundation

OTHER

collaborator

Roche Pharma AG

INDUSTRY

collaborator

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

lead

Jaeb Center for Health Research

OTHER