PROMINENT-Eye Ancillary Study (Protocol AD)



Status:Terminated
Conditions:Ocular, Ocular, Diabetes
Therapuetic Areas:Endocrinology, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:January 15, 2018
End Date:April 3, 2019

Use our guide to learn which trials are right for you!

PROMINENT-Eye Ancillary Study: Diabetic Retinopathy Outcomes in a Randomized Trial of Pemafibrate Versus Placebo (Protocol AD)

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.


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
We found this trial at
62
sites
Richmond, Virginia
Phone: 804-644-7478
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Albuquerque, New Mexico 87109
Phone: 505-842-6575
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Ann Arbor, Michigan 48105
Phone: 734-936-0138
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Asheville, North Carolina 28803
Phone: 828-255-8008
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Atlanta, Georgia 30322
Phone: 404-778-4261
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Augusta, Georgia 30909
Phone: 706-650-0061
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Austin, Texas 78705
Phone: 512-279-1252
?
mi
from
Austin, TX
Click here to add this to my saved trials
Ayer, Massachusetts 01940
Phone: 978-772-4000
?
mi
from
Ayer, MA
Click here to add this to my saved trials
Baltimore, Maryland 21237
Phone: 410-686-3394
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 21287
Phone: 410-614-6908
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
One Joslin Place
Boston, Massachusetts 02215
617-309-2400
Phone: 617-309-2520
Joslin Diabetes Center Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Boston, Massachusetts 02114
Phone: 617-367-4800
?
mi
from
Boston, MA
Click here to add this to my saved trials
Campbell, California 95008
Phone: 408-559-0666
?
mi
from
Campbell, CA
Click here to add this to my saved trials
Chapel Hill, North Carolina 27517
Phone: 919-966-5296
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28210
Phone: 704-295-3390
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chattanooga, Tennessee 37421
Phone: 423-756-1002
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Chicago, Illinois 60611
Phone: 312-695-2567
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60612
Phone: 312-355-3743
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2625 Bolton Boone Drive
DeSoto, Texas 75115
Phone: 972-283-1516
?
mi
from
DeSoto, TX
Click here to add this to my saved trials
DeSoto, Texas 75115
Phone: 972-283-1516
?
mi
from
DeSoto, TX
Click here to add this to my saved trials
Detroit, Michigan 48202
Phone: 313-874-9167
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Edmond, Oklahoma 73013
Phone: 405-607-6699
?
mi
from
Edmond, OK
Click here to add this to my saved trials
Fort Myers, Florida 33912
Phone: 239-939-4323
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
Glendale, California 91203
Phone: 818-552-5040
?
mi
from
Glendale, CA
Click here to add this to my saved trials
Glenview, Illinois 60026
Phone: 847-657-1750
?
mi
from
Glenview, IL
Click here to add this to my saved trials
Grand Rapids, Michigan 49525
Phone: 616-285-1200
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
2321 Ira East Woods Avenue
Grapevine, Texas 76051
Phone: 817-865-6800
?
mi
from
Grapevine, TX
Click here to add this to my saved trials
Houston, Texas 77030
Phone: 713-524-3434
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
Phone: 713-798-4125
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntington Beach, California 92647
Phone: 714-901-2006
?
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
653 8th Street West
Jacksonville, Florida 32209
Phone: 904-244-9361
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Knoxville, Tennessee 37909
Phone: 865-588-0811
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Lakeland, Florida 33805
Phone: 863-682-7474
?
mi
from
Lakeland, FL
Click here to add this to my saved trials
Lexington, Kentucky 40509
Phone: 859-263-3900
?
mi
from
Lexington, KY
Click here to add this to my saved trials
11234 Anderson Street
Loma Linda, California 92354
Phone: 909-558-2169
?
mi
from
Loma Linda, CA
Click here to add this to my saved trials
Long Beach, California 90807
Phone: 562-984-7024
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Madison, Wisconsin 53705
Phone: 608-263-7290
?
mi
from
Madison, WI
Click here to add this to my saved trials
McAllen, Texas 78503
Phone: 956-631-8875
?
mi
from
McAllen, TX
Click here to add this to my saved trials
Miami, Florida
Phone: 305-643-8871
?
mi
from
Miami, FL
Click here to add this to my saved trials
Minneapolis, Minnesota 55404
Phone: 612-871-2292
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Monroeville, Pennsylvania 15146
Phone: 412-683-5300
?
mi
from
Monroeville, PA
Click here to add this to my saved trials
Mountain View, California 94040
Phone: 650-988-7480
?
mi
from
Mountain View, CA
Click here to add this to my saved trials
New Albany, Indiana 47150
Phone: 800-965-3937
?
mi
from
New Albany, IN
Click here to add this to my saved trials
New York, New York 10021
Phone: 212-439-9600
?
mi
from
New York, NY
Click here to add this to my saved trials
Oak Park, Illinois 60304
Phone: 708-660-8450
?
mi
from
Oak Park, IL
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
Phone: 405-271-6307
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orlando, Florida 32805
Phone: 407-849-9621
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Overland Park, Kansas 66211
Phone: 913-663-5900
?
mi
from
Overland Park, KS
Click here to add this to my saved trials
Phoenix, Arizona 85021
Phone: 480-999-5458
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
9375 66th Street North
Pinellas Park, Florida 33782
Phone: 727-541-4469
?
mi
from
Pinellas Park, FL
Click here to add this to my saved trials
Rochester, New York 14618
Phone: 585-442-3411
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Saint Louis, Missouri 63110
Phone: 314-367-1181
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas 78240
Phone: 210-615-1311
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Antonio, Texas 78240
Phone: 210-697-2020
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Sandy Springs, Georgia 30328
Phone: 404-256-1507
?
mi
from
Sandy Springs, GA
Click here to add this to my saved trials
Sarasota, Florida 34239
Phone: 941-921-5335
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
Shawnee Mission, Kansas 66204
Phone: 913-831-7400
?
mi
from
Shawnee Mission, KS
Click here to add this to my saved trials
Syracuse, New York 13224
Phone: 315-445-8166
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
2329 West Mall
Vancouver, British Columbia V6T 1Z4
Phone: 604-875-4111
?
mi
from
Vancouver,
Click here to add this to my saved trials
West Des Moines, Iowa 50266
Phone: 515-223-8685
?
mi
from
West Des Moines, IA
Click here to add this to my saved trials
1804 North 7th Street
West Monroe, Louisiana 71291
Phone: 318-325-2610
?
mi
from
West Monroe, LA
Click here to add this to my saved trials
Westlake Village, California 91361
Phone: 805-379-0200
?
mi
from
Westlake Village, CA
Click here to add this to my saved trials