PROMINENT-Eye Ancillary Study (Protocol AD)
- Conditions
- Diabetic RetinopathyDiabetic Macular Edema
- Interventions
- Drug: Placebo
- Registration Number
- NCT03345901
- Lead Sponsor
- Jaeb Center for Health Research
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 18
-
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:
- Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity level between 20 and 53 (minimal to severe non-proliferative diabetic retinopathy (NPDR)), inclusive, on color fundus photographs confirmed by central Reading Center grading.
-
Study eye exclusion criteria are:
a. Neovascularization present. b. Current central-involved diabetic macular edema (DME based on optical coherence tomography (OCT) central subfield thickness (CST) i. Zeiss Cirrus: CST ≥ 290µm in women or ≥ 305µm in men ii. Heidelberg Spectralis: CST ≥ 305µm in women or ≥ 320µm in men c. Known major non-diabetic intraocular pathology that in the opinion of the investigator would substantially and adversely affect visual acuity or lead to ocular neovascularization during the course of the study d. Anticipated need for intravitreous anti-vascular endothelial growth factor (VEGF), intravitreous corticosteroid, or pan-retinal photocoagulation (PRP) in the next 6 months following randomization e. History of intravitreous anti-VEGF or corticosteroid treatment within the 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 of yttrium aluminum garnet (YAG) capsulotomy performed within 2 months prior to screening i. Aphakia j. Known substantial media opacities that would preclude successful imaging
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo pill orally BID Pemafibrate Pemafibrate .2 mg pemafibrate orally BID
- Primary Outcome Measures
Name Time Method Diabetic Retinopathy Worsening or Diabetic Macular Edema (DME) Development (Composite Outcome) 4 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (62)
Wilmer Eye Institute at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
University of Florida College of Med., Department of Ophthalmology, Jacksonville Health Science Cent
🇺🇸Jacksonville, Florida, United States
Valley Eye Physicians and Surgeons
🇺🇸Ayer, Massachusetts, United States
University Health Network - Toronto Western Hospital
🇨🇦Toronto, Canada
Thomas Eye Group
🇺🇸Sandy Springs, Georgia, United States
Sarasota Retina Institute
🇺🇸Sarasota, Florida, United States
Wolfe Eye Clinic
🇺🇸West Des Moines, Iowa, United States
University of Illinois at Chicago Medical Center
🇺🇸Chicago, Illinois, United States
John-Kenyon American Eye Institute
🇺🇸New Albany, Indiana, United States
Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
🇺🇸West Monroe, Louisiana, United States
Retina Associates of Western New York
🇺🇸Rochester, New York, United States
Retina Vitreous Center
🇺🇸Edmond, Oklahoma, United States
Southeastern Retina Associates, P.C.
🇺🇸Knoxville, Tennessee, United States
Retina Center of Texas
🇺🇸Grapevine, Texas, United States
Arizona Retina and Vitreous Consultants
🇺🇸Phoenix, Arizona, United States
Retina Macula Specialists of Miami
🇺🇸Miami, Florida, United States
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States
Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
🇺🇸Detroit, Michigan, United States
Retina Center, PA
🇺🇸Minneapolis, Minnesota, United States
Dean A. McGee Eye Institute
🇺🇸Oklahoma City, Oklahoma, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
Retinal Consultants of San Antonio
🇺🇸San Antonio, Texas, United States
Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
🇺🇸Pinellas Park, Florida, United States
NorthShore University HealthSystem
🇺🇸Glenview, Illinois, United States
Mid-America Retina Consultants, P.A.
🇺🇸Overland Park, Kansas, United States
Retinal Diagnostic Center
🇺🇸Campbell, California, United States
Atlantis Eye Care
🇺🇸Huntington Beach, California, United States
National Ophthalmic Research Institute
🇺🇸Fort Myers, Florida, United States
Loma Linda University Health Care, Department of Ophthalmology
🇺🇸Loma Linda, California, United States
Macula & Retina Institute
🇺🇸Glendale, California, United States
Retinal Consultants of Southern California Medical Group, Inc.
🇺🇸Westlake Village, California, United States
Florida Retina Consultants
🇺🇸Lakeland, Florida, United States
Elman Retina Group, P.A.
🇺🇸Baltimore, Maryland, United States
The Retina Institute
🇺🇸Saint Louis, Missouri, United States
Northwestern Medical Faculty Foundation
🇺🇸Chicago, Illinois, United States
Vitreo-Retinal Associates
🇺🇸Grand Rapids, Michigan, United States
Retina Associates, P.A.
🇺🇸Shawnee Mission, Kansas, United States
Valley Retina Institute
🇺🇸McAllen, Texas, United States
Southeastern Retina Associates
🇺🇸Chattanooga, Tennessee, United States
Baylor Eye Physicians and Surgeons
🇺🇸Houston, Texas, United States
Robert E. Torti, MD, PA dba Retina Specialists
🇺🇸DeSoto, Texas, United States
UBC/VCHA Eye Care Centre
🇨🇦Vancouver, British Columbia, Canada
University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service
🇺🇸Madison, Wisconsin, United States
Emory Eye Center
🇺🇸Atlanta, Georgia, United States
Southeast Retina Center, P.C.
🇺🇸Augusta, Georgia, United States
Illinois Retina Associates, S.C.
🇺🇸Oak Park, Illinois, United States
Retina and Vitreous Associates of Kentucky
🇺🇸Lexington, Kentucky, United States
Eye Associates of New Mexico
🇺🇸Albuquerque, New Mexico, United States
MaculaCare
🇺🇸New York, New York, United States
Retina-Vitreous Surgeons of Central New York, PC
🇺🇸Syracuse, New York, United States
Western Carolina Clinical Research, LLC
🇺🇸Asheville, North Carolina, United States
Retina Vitreous Consultants
🇺🇸Monroeville, Pennsylvania, United States
Charlotte Eye, Ear, Nose and Throat Assoc., PA
🇺🇸Charlotte, North Carolina, United States
Retina Consultants of Houston, PA
🇺🇸Houston, Texas, United States
Retina Institute of Virginia
🇺🇸Richmond, Virginia, United States
South Coast Retina Center
🇺🇸Long Beach, California, United States
Northern California Retina Vitreous Associates
🇺🇸Mountain View, California, United States
Retina Research Center
🇺🇸Austin, Texas, United States
Florida Retina Institute
🇺🇸Orlando, Florida, United States
Kellogg Eye Center, University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Kittner Eye Center
🇺🇸Chapel Hill, North Carolina, United States