Phase II Combination Steroid and Anti-VEGF for Persistent DME

PHASE2CompletedINTERVENTIONAL
Enrollment

129

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

June 5, 2017

Study Completion Date

June 5, 2017

Conditions
Diabetic Macular Edema
Interventions
DRUG

intravitreal ranibizumab 0.3 mg

Intravitreal injection of 0.3mg ranibizumab performed on the day of randomization and up to every 4 weeks using defined treatment criteria

DRUG

dexamethasone intravitreal implant

The dexamethasone intravitreal injection will be given within 0-8 days of the ranibizumab injection. If defined criteria are met, a second dexamethasone injection in combination with intravitreal ranibizumab (within 0-8 days) will be given at the 12 week visit. If the injections are given consecutively on the same day, the ranibizumab injection must be given first.

PROCEDURE

Sham injection

No injection is given. It is a sham injection to keep the participant masked. The sham injection will be given within 0-8 days of the ranibizumab injection. If the injections are given consecutively on the same day, the sham injection must be given first.

Trial Locations (56)

10021

MaculaCare, New York

14618

Retina Associates of Western New York, Rochester

14642

University of Rochester, Rochester

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

28210

Charlotte Eye Ear Nose and Throat Assoc, PA, Charlotte

30328

Thomas Eye Group, Sandy Springs

30909

Southeast Retina Center, P.C., Augusta

32209

University of Florida College of Med., Department of Ophthalmology, Jacksonville

33609

Retina Associates of Florida, P.A., Tampa

33805

Central Florida Retina Institute, Lakeland

33912

National Ophthalmic Research Institute, Fort Myers

34239

Sarasota Retina Institute, Sarasota

34474

Ocala Eye Retina Consultants, Ocala

37909

Southeastern Retina Associates, P.C., Knoxville

44106

Case Western Reserve University, Cleveland

44122

Retina Associates of Cleveland, Inc., Beachwood

46290

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

48439

Retina Vitreous Center, Grand Blanc

49525

Retina Specialists of Michigan, 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

63128

The Retina Institute, St Louis

66204

Retina Associates, P.A., Shawnee Mission

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

90211

Retina-Vitreous Associates Medical Group, Beverly Hills

92354

Loma Linda University Health Care, Dept. of Ophthalmology, Loma Linda

92374

Retina Consultants of Southern California, Redlands

92647

Atlantis Eye Care, Huntington Beach

93103

California Retina Consultants, Santa Barbara

94040

Northern California Retina Vitreous Associates, Mountain View

94598

Bay Area Retina Associates, Walnut Creek

95841

Retinal Consultants Medical Group, Inc., Sacramento

97210

Retina Northwest, PC, Portland

97239

Casey Eye Institute, Portland

98195

University of Washington Medical Center, Seattle

99204

Spokane Eye Clinic, Spokane

06320

Retina Group of New England, New London

06360

New England Retina Associates, Norwich

20892-2510

National Eye Institute/National Institutes of Health, Bethesda

02114

Ophthalmic Consultants of Boston, Boston

02215

Joslin Diabetes Center, Boston

07103

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

Sponsors
All Listed Sponsors
collaborator

Allergan

INDUSTRY

collaborator

Genentech, Inc.

INDUSTRY

collaborator

National Eye Institute (NEI)

NIH

lead

Jaeb Center for Health Research

OTHER