PROMINENT-Eye Ancillary Study (Protocol AD)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Diabetic Retinopathy, Diabetic Macular Edema

In brief

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.

Key facts

Study ID

NCT03345901

Run by

Jaeb Center for Health Research

People needed

18

Starts

2018-01-15

Expected to finish

2019-04-03

Last updated by the study team

2020-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Retinal Diagnostic Center — Campbell, California, United States
• Macula & Retina Institute — Glendale, California, United States
• Atlantis Eye Care — Huntington Beach, California, United States
• Loma Linda University Health Care, Department of Ophthalmology — Loma Linda, California, United States
• South Coast Retina Center — Long Beach, California, United States
• Northern California Retina Vitreous Associates — Mountain View, California, United States
• Retinal Consultants of Southern California Medical Group, Inc. — Westlake Village, California, United States
• National Ophthalmic Research Institute — Fort Myers, Florida, United States
• University of Florida College of Med., Department of Ophthalmology, Jacksonville Health Science Cent — Jacksonville, Florida, United States
• Florida Retina Consultants — Lakeland, Florida, United States
• Retina Macula Specialists of Miami — Miami, Florida, United States
• Florida Retina Institute — Orlando, Florida, United States
• Southeast Eye Institute, P.A. dba Eye Associates of Pinellas — Pinellas Park, Florida, United States
• Sarasota Retina Institute — Sarasota, Florida, United States
• Emory Eye Center — Atlanta, Georgia, United States
• Emory Eye Center — Atlanta, Georgia, United States
• Southeast Retina Center, P.C. — Augusta, Georgia, United States
• Thomas Eye Group — Sandy Springs, Georgia, United States
• Northwestern Medical Faculty Foundation — Chicago, Illinois, United States
• Northwestern Medical Faculty Foundation — Chicago, Illinois, United States
• University of Illinois at Chicago Medical Center — Chicago, Illinois, United States
• NorthShore University HealthSystem — Glenview, Illinois, United States
• Illinois Retina Associates, S.C. — Oak Park, Illinois, United States
• John-Kenyon American Eye Institute — New Albany, Indiana, United States
• Arizona Retina and Vitreous Consultants — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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