Treatment for CI-DME in Eyes With Very Good VA Study

PHASE3CompletedINTERVENTIONAL
Enrollment

702

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

September 11, 2018

Study Completion Date

September 11, 2018

Conditions
Diabetic Macular Edema
Interventions
PROCEDURE

Prompt Laser

Focal/grid laser performed at baseline and as needed during follow-up

DRUG

Prompt aflibercept

Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria

PROCEDURE

Deferred laser

Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met

DRUG

Deferred aflibercept

Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria

Trial Locations (103)

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

14209

Ross Eye Institute, SUNY Buffalo, Buffalo

14618

Retina Associates of Western New York, Rochester

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

23235

Retina Institute of Virginia, Richmond

23298

Virginia Commonwealth University, Dept. of Ophthalmology, Richmond

28210

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

28803

Western Carolina Retinal Associates, PA, 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

32803

Magruder Eye Institute, Orlando

33126

Retina Macula Specialists of Miami, Miami

33136

Bascom Palmer Eye Institute, Miami

33324

Fort Lauderdale Eye Institute, Plantation

33609

Retina Associates of Florida, P.A., Tampa

33805

Florida Retina Consultants, Lakeland

33912

National Ophthalmic Research Institute, Fort Myers

34239

Center for Sight, Sarasota

Sarasota Retina Institute, Sarasota

34474

Ocala Eye Retina Consultants, Ocala

37421

Southeastern Retina Associates, Chattanooga

37660

Southeastern Retina Associates, PC, Kingsport

37909

Southeastern Retina Associates, P.C., Knoxville

40509

Retina and Vitreous Associates of Kentucky, Lexington

42001

Paducah Retinal Center, Paducah

44106

Case Western Reserve University, Cleveland

44122

Retina Associates of Cleveland, Inc., Beachwood

46290

Raj Maturi, Indianapolis

47150

John-Kenyon American Eye Institute, New Albany

48105

Kellogg Eye Center, University of Michigan, Ann Arbor

48202

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

48439

Retina Vitreous Center, Grand Blanc

48603

Andersen Eye Associates, Saginaw

49525

Retina Specialists of Michigan, Grand Rapids

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

55455

University of Minnesota, Minneapolis

55905

Mayo Clinic Department of Ophthalmology, Rochester

60026

NorthShore University HealthSystem, Glenview

60435

Illinois Retina Associates, Joliet

60452

University Retina and Macula Associates, Oak Forest

60611

Northwestern Medical Faculty Foundation, Chicago

60612

University of Illinois at Chicago Medical Center, Chicago

61801

Carle Foundation Hospital, Urbana

63128

The Retina Institute, St Louis

64111

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

66204

Retina Associates, P.A., Shawnee Mission

66208

University of Kansas Medical Center, Dept. of Ophthalmology, Prairie Village

73013

Retina Vitreous Center, Edmond

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

85021

Arizona Retina and Vitreous Consultants, Phoenix

85711

University of Arizona Medical Center/Department of Ophthalmology, Tucson

87102

Eye Associates of New Mexico, Albuquerque

90807

South Coast Retina Center, Long Beach

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

92374

Retina Consultants of Southern California, Redlands

93103

California Retina Consultants, Santa Barbara

94598

Bay Area Retina Associates, Walnut Creek

95008

Retinal Diagnostic Center, Campbell

95841

Retinal Consultants Medical Group, Inc., Sacramento

97210

Retina Northwest, PC, Portland

97239

Casey Eye Institute, Portland

97401

Oregon Retina, LLP, Eugene

98104

University of Washington Medical Center, Seattle

99204

Spokane Eye Clinic, Spokane

72205-7199

Jones Eye Institute/University of Arkansas for Medical Sciences, Little Rock

06320

Retina Group of New England, New London

06360

New England Retina Associates, Norwich

21287-9277

Wilmer Eye Institute at Johns Hopkins, Baltimore

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

08225

Retinal and Ophthalmic Consultants, PC, Northfield

27599-7040

University of North Carolina, Chapel Hill

17601-2644

Family Eye Group, Lancaster

T5H 0X5

Alberta Retina Consultants, Edmonton

M5T 258

University Health Network - Toronto Western Hospital, Toronto

V5Z 3N9

UBC/VCHA Eye Care Centre, Vancouver

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

collaborator

National Eye Institute (NEI)

NIH

collaborator

National Institutes of Health (NIH)

NIH

lead

Jaeb Center for Health Research

OTHER