Phase
Condition
Diabetic Macular Edema
Diabetic Retinopathy
Retina
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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:
- Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severitylevel between 20 and 53 (minimal to severe non-proliferative diabetic retinopathy (NPDR)), inclusive, on color fundus photographs confirmed by central ReadingCenter grading.
Exclusion
Exclusion Criteria:
- Study eye exclusion criteria are: a. Neovascularization present. b. Current central-involved diabetic macular edema (DMEbased on optical coherence tomography (OCT) central subfield thickness (CST) i. ZeissCirrus: CST ≥ 290µm in women or ≥ 305µm in men ii. Heidelberg Spectralis: CST ≥ 305µmin women or ≥ 320µm in men c. Known major non-diabetic intraocular pathology that inthe opinion of the investigator would substantially and adversely affect visual acuityor lead to ocular neovascularization during the course of the study d. Anticipatedneed for intravitreous anti-vascular endothelial growth factor (VEGF), intravitreouscorticosteroid, or pan-retinal photocoagulation (PRP) in the next 6 months followingrandomization e. History of intravitreous anti-VEGF or corticosteroid treatment withinthe 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 ofyttrium aluminum garnet (YAG) capsulotomy performed within 2 months prior to screeningi. Aphakia j. Known substantial media opacities that would preclude successful imaging
Study Design
Connect with a study center
UBC/VCHA Eye Care Centre
Vancouver, British Columbia V5Z 3N9
CanadaSite Not Available
University Health Network - Toronto Western Hospital
Toronto, M5T 2S8
CanadaSite Not Available
Arizona Retina and Vitreous Consultants
Phoenix, Arizona 85021
United StatesSite Not Available
Retinal Diagnostic Center
Campbell, California 95008
United StatesSite Not Available
Macula & Retina Institute
Glendale, California 91203
United StatesSite Not Available
Atlantis Eye Care
Huntington Beach, California 92647
United StatesSite Not Available
Loma Linda University Health Care, Department of Ophthalmology
Loma Linda, California 92354
United StatesSite Not Available
South Coast Retina Center
Long Beach, California 90807
United StatesSite Not Available
Northern California Retina Vitreous Associates
Mountain View, California 94040
United StatesSite Not Available
Retinal Consultants of Southern California Medical Group, Inc.
Westlake Village, California 91361
United StatesSite Not Available
National Ophthalmic Research Institute
Fort Myers, Florida 33912
United StatesSite Not Available
University of Florida College of Med., Department of Ophthalmology, Jacksonville Health Science Cent
Jacksonville, Florida 32209
United StatesSite Not Available
Florida Retina Consultants
Lakeland, Florida 33805
United StatesSite Not Available
Retina Macula Specialists of Miami
Miami, Florida 33126
United StatesSite Not Available
Florida Retina Institute
Orlando, Florida 32806
United StatesSite Not Available
Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
Pinellas Park, Florida 33782
United StatesSite Not Available
Sarasota Retina Institute
Sarasota, Florida 34239
United StatesSite Not Available
Emory Eye Center
Atlanta, Georgia 30322
United StatesSite Not Available
Southeast Retina Center, P.C.
Augusta, Georgia 30909
United StatesSite Not Available
Thomas Eye Group
Sandy Springs, Georgia 30328
United StatesSite Not Available
Northwestern Medical Faculty Foundation
Chicago, Illinois 60611
United StatesSite Not Available
University of Illinois at Chicago Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
NorthShore University HealthSystem
Glenview, Illinois 60026
United StatesSite Not Available
Illinois Retina Associates, S.C.
Oak Park, Illinois 60304
United StatesSite Not Available
John-Kenyon American Eye Institute
New Albany, Indiana 47150
United StatesSite Not Available
Wolfe Eye Clinic
West Des Moines, Iowa 50266
United StatesSite Not Available
Mid-America Retina Consultants, P.A.
Overland Park, Kansas 66211
United StatesSite Not Available
Retina Associates, P.A.
Shawnee Mission, Kansas 66204
United StatesSite Not Available
Retina and Vitreous Associates of Kentucky
Lexington, Kentucky 40509
United StatesSite Not Available
Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
West Monroe, Louisiana 71291-4452
United StatesSite Not Available
Elman Retina Group, P.A.
Baltimore, Maryland 21237
United StatesSite Not Available
Wilmer Eye Institute at Johns Hopkins
Baltimore, Maryland 21287
United StatesSite Not Available
Valley Eye Physicians and Surgeons
Ayer, Massachusetts 01432
United StatesSite Not Available
Joslin Diabetes Center
Boston, Massachusetts 02215
United StatesSite Not Available
Ophthalmic Consultants of Boston
Boston, Massachusetts 02114
United StatesSite Not Available
Kellogg Eye Center, University of Michigan
Ann Arbor, Michigan 48105
United StatesSite Not Available
Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
Detroit, Michigan 48202
United StatesSite Not Available
Vitreo-Retinal Associates
Grand Rapids, Michigan 49546
United StatesSite Not Available
Retina Center, PA
Minneapolis, Minnesota 55404
United StatesSite Not Available
The Retina Institute
Saint Louis, Missouri 63128
United StatesSite Not Available
Eye Associates of New Mexico
Albuquerque, New Mexico 87109
United StatesSite Not Available
MaculaCare
New York, New York 10021
United StatesSite Not Available
Retina Associates of Western New York
Rochester, New York 14620
United StatesSite Not Available
Retina-Vitreous Surgeons of Central New York, PC
Syracuse, New York 13224
United StatesSite Not Available
Western Carolina Clinical Research, LLC
Asheville, North Carolina 28803
United StatesSite Not Available
Kittner Eye Center
Chapel Hill, North Carolina 27517-8923
United StatesSite Not Available
Charlotte Eye, Ear, Nose and Throat Assoc., PA
Charlotte, North Carolina 28210
United StatesSite Not Available
Retina Vitreous Center
Edmond, Oklahoma 73103
United StatesSite Not Available
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Retina Vitreous Consultants
Monroeville, Pennsylvania 15146
United StatesSite Not Available
Southeastern Retina Associates
Chattanooga, Tennessee 37421
United StatesSite Not Available
Southeastern Retina Associates, P.C.
Knoxville, Tennessee 37909
United StatesSite Not Available
Retina Research Center
Austin, Texas 78705
United StatesSite Not Available
Robert E. Torti, MD, PA dba Retina Specialists
DeSoto, Texas 75115-2011
United StatesSite Not Available
Valley Retina Institute
DeSoto, Texas 75115
United StatesSite Not Available
Retina Center of Texas
Grapevine, Texas 76051
United StatesSite Not Available
Baylor Eye Physicians and Surgeons
Houston, Texas 77030
United StatesSite Not Available
Retina Consultants of Houston, PA
Houston, Texas 77030
United StatesSite Not Available
Valley Retina Institute
McAllen, Texas 78503
United StatesSite Not Available
Medical Center Ophthalmology Associates
San Antonio, Texas 78240
United StatesSite Not Available
Retinal Consultants of San Antonio
San Antonio, Texas 78240
United StatesSite Not Available
Retina Institute of Virginia
Richmond, Virginia 23235
United StatesSite Not Available
University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service
Madison, Wisconsin 53705
United StatesSite Not Available
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