Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema

PHASE3CompletedINTERVENTIONAL
Enrollment

660

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

October 31, 2014

Study Completion Date

April 18, 2019

Conditions
Diabetic Macular Edema
Interventions
DRUG

2.0 mg intravitreal aflibercept

Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.

DRUG

1.25 mg intravitreal bevacizumab

Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.

DRUG

0.3 mg intravitreal ranibizumab

Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.

Trial Locations (90)

10003

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

10021

MaculaCare, New York

10029

Mount Sinai School of Medicine, Dept. of Ophthalmology, New York

13224

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

14618

Retina Associates of Western New York, Rochester

14642

University of Rochester, Rochester

15213

Retina Vitrous Consultants, Pittsburgh

19104

University of Pennsylvania Scheie Eye Institute, Philadelphia

20176

Virginia Retina Center, Leesburg

21237

Elman Retina Group, P.A., Baltimore

23235

Retina Institute of Virginia, Richmond

27157

Wake Forest University Eye Center, Winston-Salem

28210

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

28803

Western Carolina Retinal Associates, PA, Asheville

29169

Palmetto Retina Center, Columbia

29223

Carolina Retina Center, Columbia

29425

Storm Eye Institute, Medical University of South Carolina, Charleston

30322

Emory Eye Center, Atlanta

30342

Georgia Retina, P.C., Atlanta

Thomas Eye Group, Atlanta

30909

Southeast Retina Center, P.C., Augusta

32803

Magruder Eye Institute, Orlando

33324

Fort Lauderdale Eye Institute, Plantation

33334

Retina Group of Florida, Fort Lauderdale

33609

Retina Associates of Florida, P.A., Tampa

33761

Gulf Coast Retina Center, Clearwater

33805

Central Florida Retina Institute, Lakeland

33912

National Ophthalmic Research Institute, Fort Myers

34239

Sarasota Retina Institute, Sarasota

34474

Ocala Eye Retina Consultants, Ocala

37660

Southeastern Retina Associates, PC, Kingsport

37909

Southeastern Retina Associates, P.C., Knoxville

42001

Paducah Retinal Center, Paducah

43212

OSU Eye Physicians and Surgeons, LLC., Columbus

44106

Case Western Reserve University, Cleveland

44122

Retina Associates of Cleveland, Inc., Beachwood

46280

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

47150

John-Kenyon American Eye Institute, New Albany

48202

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

48439

Retina Vitrous Center, Grand Blanc

49525

Retina Specialists of Michigan, Grand Rapids

Vitreo-Retinal Associates, Grand Rapids

50266

Wolfe Eye Clinic, West Des Moines

52002

Medical Associates Clinic, P.C., Dubuque

53226

Medical College of Wiconsin, Milwaukee

53705

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

55404

Retina Center, PA, Minneapolis

55905

Mayo Clinic Department of Ophthalmology, Rochester

60026

NorthShore University HealthSystem, Glenview

60611

Northwestern Medical Faculty Foundation, Chicago

60612

University of Illinois at Chicago Medical Center, Chicago

63110

Barnes Retina Institute, St Louis

66204

Retina Associates, P.A., Shawnee Mission

73013

Retina Vitreous Center, Edmond

73104

Dean A. McGee Eye Institute, Oklahoma City

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

84107

Retina Associates of Utah, P.C., Salt Lake City

85710

Retina Associates, Tucson

87102

Eye Associates of New Mexico, Albuquerque

90211

Retina-Vitreous Associates Medical Group, Beverly Hills

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, Dept. of Ophthalmology, Loma Linda

93103

California Retina Consultants, Santa Barbara

94598

Bay Area Retina Associates, Walnut Creek

96701

Retina Consultants of Hawaii, Inc., Honolulu

97210

Retina Northwest, PC, Portland

97239

Casey Eye Institute, Portland

98195

University of Washington Medical Center, Seattle

99204

Spokane Eye Clinic, Spokane

871310001

University of New Mexico Health Sciences Center, Albuquerque

06360

New England Retina Associates, Norwich

40509-1802

Retina and Vitreous Associates of Kentucky, Lexington

21287-9277

Wilmer Eye Institute at Johns Hopkins, Baltimore

02114

Ophthalmic Consultants of Boston, Boston

02215

Joslin Diabetes Center, Boston

01605

Vitreo-Retinal Associates, PC, Worcester

03801

Eyesight Ophthalmic Services, PA, Portsmouth

07103

The Institute of Ophthalmology and Visual Science (IOVS), Newark

10467-2401

Montefiore Medical Center, The Bronx

27599-7040

University of North Carolina, Chapel Hill

17601-2644

Family Eye Group, Lancaster

Sponsors
All Listed Sponsors
collaborator

National Eye Institute (NEI)

NIH

collaborator

Genentech, Inc.

INDUSTRY

collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Jaeb Center for Health Research

OTHER