Anti-VEGF Treatment for Prevention of PDR/DME

PHASE3CompletedINTERVENTIONAL
Enrollment

399

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

May 31, 2020

Study Completion Date

May 11, 2022

Conditions
Diabetic RetinopathyDiabetic Macular Edema
Interventions
PROCEDURE

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.

DRUG

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.

PROCEDURE

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

DRUG

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.

Trial Locations (85)

10003

The New York Eye and Ear Infirmary/Faculty Eye Practice, New York

10021

MaculaCare, New York

13224

Retina-Vitreous Surgeons of Central New York, PC, Syracuse

14642

University of Rochester, Rochester

15146

Retina Vitreous Consultants, Monroeville

19104

University of Pennsylvania Scheie Eye Institute, Philadelphia

21237

Elman Retina Group, P.A., Baltimore

21287

Wilmer Eye Institute at Johns Hopkins, Baltimore

21740

Mid Atlantic Retina Specialists, Hagerstown

23235

Retina Institute of Virginia, Richmond

23298

Virginia Commonwealth University, Dept. of Ophthalmology, Richmond

27517

Kittner Eye Center, Chapel Hill

28210

Charlotte Eye, Ear, Nose and Throat Assoc., PA, Charlotte

28803

Western Carolina Clinical Research, LLC, Asheville

29169

Palmetto Retina Center, West Columbia

29223

Carolina Retina Center, Columbia

30060

Marietta Eye Clinic, Marietta

30322

Emory Eye Center, Atlanta

30328

Thomas Eye Group, Sandy Springs

30909

Southeast Retina Center, P.C., Augusta

32209

University of Florida College of Med., Department of Ophthalmology, Jacksonville Health Science Cent, Jacksonville

32216

Florida Retina Institute-Jacksonville, Jacksonville

32803

Magruder Eye Institute, Orlando

32806

Florida Retina Institute, Orlando

33136

Bascom Palmer Eye Institute, Miami

33308

Retina Group of Florida, Fort Lauderdale

33324

Fort Lauderdale Eye Institute, Plantation

33609

Retina Associates of Florida, P.A., Tampa

33782

Southeast Eye Institute, P.A. dba Eye Associates of Pinellas, Pinellas Park

33805

Florida Retina Consultants, Lakeland

33912

National Ophthalmic Research Institute, Fort Myers

34239

Sarasota Retina Institute, Sarasota

37421

Southeastern Retina Associates, Chattanooga

37909

Southeastern Retina Associates, P.C., Knoxville

42001

Paducah Retinal Center, Paducah

44106

University Hospitals Cleveland Medical Center, Cleveland

44122

Retina Associates of Cleveland, Inc., Beachwood

46290

Raj K. Maturi, M.D., P.C., Indianapolis

48202

Henry Ford Health System, Dept of Ophthalmology and Eye Care Services, Detroit

49546

Vitreo-Retinal Associates, Grand Rapids

50266

Wolfe Eye Clinic, West Des Moines

52002

Medical Associates Clinic, P.C., Dubuque

53705

University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service, Madison

55404

Retina Center, PA, Minneapolis

60611

Northwestern Medical Faculty Foundation, Chicago

60612

University of Illinois at Chicago Medical Center, Chicago

61704

Gailey Eye Clinic, Bloomington

62703

Springfield Clinic, LLP, Springfield

64111

Mid-America Retina Consultants, P.A., Kansas City

66204

Retina Associates, P.A., Shawnee Mission

71291

Eye Associates of Northeast Louisiana dba Haik Humble Eye Center, West Monroe

75115

Robert E. Torti, MD, PA dba Retina Specialists, DeSoto

76051

Retina Center of Texas, Grapevine

77025

Retina and Vitreous of Texas, Houston

77030

Baylor Eye Physicians and Surgeons, Houston

Retina Consultants of Houston, PA, Houston

78240

Retinal Consultants of San Antonio, San Antonio

78503

Valley Retina Institute, McAllen

78705

Austin Retina Associates, Austin

Retina Research Center, Austin

79106

Southwest Retina Specialists, Amarillo

79424

Texas Retina Associates, Lubbock

85021

Arizona Retina and Vitreous Consultants, Phoenix

85711

University of Arizona Medical Center/Department of Ophthalmology, Tucson

87109

Eye Associates of New Mexico, Albuquerque

91361

Retinal Consultants of Southern California Medical Group, Inc., Westlake Village

92211

Southern California Desert Retina Consultants, MC, Palm Desert

92354

Loma Linda University Health Care, Department of Ophthalmology, Loma Linda

92374

Retina Consultants of Southern California, Redlands

92647

Atlantis Eye Care, Huntington Beach

93103

California Retina Consultants, Santa Barbara

93257

Shashi D Ganti, MD PC, Porterville

94609

East Bay Retina Consultants, Inc., Oakland

95817

U.C. Davis Eye Center, Sacramento

97210

Retina Northwest, PC, Portland

97239

Casey Eye Institute, Portland

97401

Oregon Retina, LLP, Eugene

06518

New England Retina Associates, Hamden

01432

Valley Eye Physicians and Surgeons, Ayer

02215

Joslin Diabetes Center, Boston

08225

Retinal and Ophthalmic Consultants, PC, Northfield

V5Z 3N9

UBC/VCHA Eye Care Centre, Vancouver

B3H 2Y9

Nova Scotia District Health Authority, Halifax

M3C 0G9

Toronto Retina Institute (TRI), North York

M5T 2S8

University Health Network - Toronto Western Hospital, Toronto

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

collaborator

Juvenile Diabetes Research Foundation

OTHER

collaborator

National Eye Institute (NEI)

NIH

collaborator

National Institutes of Health (NIH)

NIH

lead

Jaeb Center for Health Research

OTHER