Laser-Ranibizumab-Triamcinolone for Diabetic Macular Edema

PHASE3CompletedINTERVENTIONAL
Enrollment

691

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

December 31, 2009

Study Completion Date

February 28, 2014

Conditions
Diabetic RetinopathyDiabetic Macular Edema
Interventions
DRUG

Triamcinolone Acetonide + laser

4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.

DRUG

Ranibizumab + laser

0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.

DRUG

Sham injection + laser

Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.

DRUG

Ranibizumab + deferred laser

0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.

Trial Locations (50)

10003

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

13224

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

17033

Penn State College of Medicine, Hershey

19104

University of Pennsylvania Scheie Eye Institute, Philadelphia

21237

Elman Retina Group, P.A., Baltimore

21801

Retina Consultants of Delmarva, P.A., Salisbury

27157

Wake Forest University Eye Center, Winston-Salem

28210

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

29169

Palmetto Retina Center, Columbia

29223

Carolina Retina Center, Columbia

30909

Southeast Retina Center, P.C., Augusta

32209

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

33334

Retina Vitreous Consultants, Fort Lauderdale

33805

Central Florida Retina Institute, Lakeland

33912

Retina Consultants of Southwest Florida, Fort Myers

37660

Southeastern Retina Associates, PC, Kingsport

37909

Southeastern Retina Associates, P.C., Knoxville

42001

Paducah Retinal Center, Paducah

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

52002

Medical Associates Clinic, P.C., Dubuque

53226

Medical College of Wisconsin, Milwaukee

53705

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

55404

Retina Center, PA, Minneapolis

60435

Illinois Retina Associates, Joliet

75231

Texas Retina Associates, Dallas

77025

Retina and Vitreous of Texas, Houston

77030

Vitreoretinal Consultants, Houston

78705

Retina Research Center, Austin

79424

Texas Retina Associates, Lubbock

79605

West Texas Retina Consultants P.A., Abilene

90211

Retina-Vitreous Associates Medical Group, Beverly Hills

90701

Sall Research Medical Center, Artesia

92262

Southern California Desert Retina Consultants, MC, Palm Springs

92354

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

92697

University of California, Irvine, Irvine

93103

California Retina Consultants, Santa Barbara

94598

Bay Area Retina Associates, Walnut Creek

97210

Retina Northwest, PC, Portland

97239

Casey Eye Institute, Portland

98195

University of Washington Medical Center, Seattle

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

03801

Eyesight Ophthalmic Services, PA, Portsmouth

27599-7040

University of North Carolina, Dept of Ophthalmology, Chapel Hill

02903

Retina Consultants, Providence

Sponsors
All Listed Sponsors
lead

Jaeb Center for Health Research

OTHER

collaborator

National Eye Institute (NEI)

NIH

collaborator

Allergan

INDUSTRY

collaborator

Genentech, Inc.

INDUSTRY