399
Participants
Start Date
January 31, 2016
Primary Completion Date
May 31, 2020
Study Completion Date
May 11, 2022
Prompt Sham
A sham injection (syringe without a needle pressed against the injection site) is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.
Prompt aflibercept
Intravitreal injection of 2.0mg aflibercept is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.
Deferred laser
Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met
Deferred aflibercept
Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria.
The New York Eye and Ear Infirmary/Faculty Eye Practice, New York
MaculaCare, New York
Retina-Vitreous Surgeons of Central New York, PC, Syracuse
University of Rochester, Rochester
Retina Vitreous Consultants, Monroeville
University of Pennsylvania Scheie Eye Institute, Philadelphia
Elman Retina Group, P.A., Baltimore
Wilmer Eye Institute at Johns Hopkins, Baltimore
Mid Atlantic Retina Specialists, Hagerstown
Retina Institute of Virginia, Richmond
Virginia Commonwealth University, Dept. of Ophthalmology, Richmond
Kittner Eye Center, Chapel Hill
Charlotte Eye, Ear, Nose and Throat Assoc., PA, Charlotte
Western Carolina Clinical Research, LLC, Asheville
Palmetto Retina Center, West Columbia
Carolina Retina Center, Columbia
Marietta Eye Clinic, Marietta
Emory Eye Center, Atlanta
Thomas Eye Group, Sandy Springs
Southeast Retina Center, P.C., Augusta
University of Florida College of Med., Department of Ophthalmology, Jacksonville Health Science Cent, Jacksonville
Florida Retina Institute-Jacksonville, Jacksonville
Magruder Eye Institute, Orlando
Florida Retina Institute, Orlando
Bascom Palmer Eye Institute, Miami
Retina Group of Florida, Fort Lauderdale
Fort Lauderdale Eye Institute, Plantation
Retina Associates of Florida, P.A., Tampa
Southeast Eye Institute, P.A. dba Eye Associates of Pinellas, Pinellas Park
Florida Retina Consultants, Lakeland
National Ophthalmic Research Institute, Fort Myers
Sarasota Retina Institute, Sarasota
Southeastern Retina Associates, Chattanooga
Southeastern Retina Associates, P.C., Knoxville
Paducah Retinal Center, Paducah
University Hospitals Cleveland Medical Center, Cleveland
Retina Associates of Cleveland, Inc., Beachwood
Raj K. Maturi, M.D., P.C., Indianapolis
Henry Ford Health System, Dept of Ophthalmology and Eye Care Services, Detroit
Vitreo-Retinal Associates, Grand Rapids
Wolfe Eye Clinic, West Des Moines
Medical Associates Clinic, P.C., Dubuque
University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service, Madison
Retina Center, PA, Minneapolis
Northwestern Medical Faculty Foundation, Chicago
University of Illinois at Chicago Medical Center, Chicago
Gailey Eye Clinic, Bloomington
Springfield Clinic, LLP, Springfield
Mid-America Retina Consultants, P.A., Kansas City
Retina Associates, P.A., Shawnee Mission
Eye Associates of Northeast Louisiana dba Haik Humble Eye Center, West Monroe
Robert E. Torti, MD, PA dba Retina Specialists, DeSoto
Retina Center of Texas, Grapevine
Retina and Vitreous of Texas, Houston
Baylor Eye Physicians and Surgeons, Houston
Retina Consultants of Houston, PA, Houston
Retinal Consultants of San Antonio, San Antonio
Valley Retina Institute, McAllen
Austin Retina Associates, Austin
Retina Research Center, Austin
Southwest Retina Specialists, Amarillo
Texas Retina Associates, Lubbock
Arizona Retina and Vitreous Consultants, Phoenix
University of Arizona Medical Center/Department of Ophthalmology, Tucson
Eye Associates of New Mexico, Albuquerque
Retinal Consultants of Southern California Medical Group, Inc., Westlake Village
Southern California Desert Retina Consultants, MC, Palm Desert
Loma Linda University Health Care, Department of Ophthalmology, Loma Linda
Retina Consultants of Southern California, Redlands
Atlantis Eye Care, Huntington Beach
California Retina Consultants, Santa Barbara
Shashi D Ganti, MD PC, Porterville
East Bay Retina Consultants, Inc., Oakland
U.C. Davis Eye Center, Sacramento
Retina Northwest, PC, Portland
Casey Eye Institute, Portland
Oregon Retina, LLP, Eugene
New England Retina Associates, Hamden
Valley Eye Physicians and Surgeons, Ayer
Joslin Diabetes Center, Boston
Retinal and Ophthalmic Consultants, PC, Northfield
UBC/VCHA Eye Care Centre, Vancouver
Nova Scotia District Health Authority, Halifax
Toronto Retina Institute (TRI), North York
University Health Network - Toronto Western Hospital, Toronto
Lead Sponsor
Collaborators (1)
Regeneron Pharmaceuticals
INDUSTRY
Juvenile Diabetes Research Foundation
OTHER
National Eye Institute (NEI)
NIH
National Institutes of Health (NIH)
NIH
Jaeb Center for Health Research
OTHER