Diabetic Retinopathy Clinical Trial
Official title:
PROMINENT-Eye Ancillary Study: Diabetic Retinopathy Outcomes in a Randomized Trial of Pemafibrate Versus Placebo (Protocol AD)
| Verified date | August 2020 |
| Source | Jaeb Center for Health Research |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 18 |
| Est. completion date | April 3, 2019 |
| Est. primary completion date | April 3, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 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. Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | University Health Network - Toronto Western Hospital | Toronto | |
| Canada | UBC/VCHA Eye Care Centre | Vancouver | British Columbia |
| United States | Eye Associates of New Mexico | Albuquerque | New Mexico |
| United States | Eye Associates of New Mexico | Albuquerque | New Mexico |
| United States | Kellogg Eye Center, University of Michigan | Ann Arbor | Michigan |
| United States | Western Carolina Clinical Research, LLC | Asheville | North Carolina |
| 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 | Retina Research Center | Austin | Texas |
| United States | Valley Eye Physicians and Surgeons | Ayer | Massachusetts |
| United States | Elman Retina Group, P.A. | Baltimore | Maryland |
| United States | Wilmer Eye Institute at Johns Hopkins | Baltimore | Maryland |
| United States | Joslin Diabetes Center | Boston | Massachusetts |
| United States | Ophthalmic Consultants of Boston | Boston | Massachusetts |
| United States | Retinal Diagnostic Center | Campbell | California |
| United States | Kittner Eye Center | Chapel Hill | North Carolina |
| United States | Kittner Eye Center | Chapel Hill | North Carolina |
| United States | Charlotte Eye, Ear, Nose and Throat Assoc., PA | Charlotte | North Carolina |
| United States | Southeastern Retina Associates | Chattanooga | Tennessee |
| 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 | Robert E. Torti, MD, PA dba Retina Specialists | DeSoto | Texas |
| United States | Valley Retina Institute | DeSoto | Texas |
| United States | Henry Ford Health System, Dept of Ophthalmology and Eye Care Services | Detroit | Michigan |
| United States | Henry Ford Health System, Dept of Ophthalmology and Eye Care Services | Detroit | Michigan |
| United States | Retina Vitreous Center | Edmond | Oklahoma |
| United States | National Ophthalmic Research Institute | Fort Myers | Florida |
| United States | Macula & Retina Institute | Glendale | California |
| United States | NorthShore University HealthSystem | Glenview | Illinois |
| United States | Vitreo-Retinal Associates | Grand Rapids | Michigan |
| United States | Retina Center of Texas | Grapevine | Texas |
| United States | Baylor Eye Physicians and Surgeons | Houston | Texas |
| United States | Baylor Eye Physicians and Surgeons | Houston | Texas |
| United States | Retina Consultants of Houston, PA | Houston | Texas |
| United States | Atlantis Eye Care | Huntington Beach | California |
| United States | University of Florida College of Med., Department of Ophthalmology, Jacksonville Health Science Cent | Jacksonville | Florida |
| United States | Southeastern Retina Associates, P.C. | Knoxville | Tennessee |
| United States | Florida Retina Consultants | Lakeland | Florida |
| United States | Retina and Vitreous Associates of Kentucky | Lexington | Kentucky |
| United States | Loma Linda University Health Care, Department of Ophthalmology | Loma Linda | California |
| United States | South Coast Retina Center | Long Beach | California |
| United States | University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service | Madison | Wisconsin |
| United States | Valley Retina Institute | McAllen | Texas |
| United States | Retina Macula Specialists of Miami | Miami | Florida |
| United States | Retina Center, PA | Minneapolis | Minnesota |
| United States | Retina Center, PA | Minneapolis | Minnesota |
| United States | Retina Vitreous Consultants | Monroeville | Pennsylvania |
| United States | Northern California Retina Vitreous Associates | Mountain View | California |
| United States | John-Kenyon American Eye Institute | New Albany | Indiana |
| United States | MaculaCare | New York | New York |
| United States | Illinois Retina Associates, S.C. | Oak Park | Illinois |
| United States | Dean A. McGee Eye Institute | Oklahoma City | Oklahoma |
| United States | Florida Retina Institute | Orlando | Florida |
| United States | Mid-America Retina Consultants, P.A. | Overland Park | Kansas |
| United States | Arizona Retina and Vitreous Consultants | Phoenix | Arizona |
| United States | Southeast Eye Institute, P.A. dba Eye Associates of Pinellas | Pinellas Park | Florida |
| United States | Retina Institute of Virginia | Richmond | Virginia |
| United States | Retina Associates of Western New York | Rochester | New York |
| United States | The Retina Institute | Saint Louis | Missouri |
| United States | Medical Center Ophthalmology Associates | San Antonio | Texas |
| United States | Retinal Consultants of San Antonio | San Antonio | Texas |
| United States | Thomas Eye Group | Sandy Springs | Georgia |
| United States | Sarasota Retina Institute | Sarasota | Florida |
| United States | Retina Associates, P.A. | Shawnee Mission | Kansas |
| United States | Retina-Vitreous Surgeons of Central New York, PC | Syracuse | New York |
| United States | Wolfe Eye Clinic | West Des Moines | Iowa |
| United States | Eye Associates of Northeast Louisiana dba Haik Humble Eye Center | West Monroe | Louisiana |
| United States | Eye Associates of Northeast Louisiana dba Haik Humble Eye Center | West Monroe | Louisiana |
| United States | Retinal Consultants of Southern California Medical Group, Inc. | Westlake Village | California |
| Lead Sponsor | Collaborator |
|---|---|
| Jaeb Center for Health Research | Kowa Company, Ltd. |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Diabetic Retinopathy Worsening or Diabetic Macular Edema (DME) Development (Composite Outcome) | 4 years |
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