840
Participants
Start Date
July 31, 2004
Primary Completion Date
May 31, 2008
Study Completion Date
October 31, 2008
Standard of Care Group
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
1mg triamcinolone acetonide
Intravitreal injection of 1mg of triamcinolone acetonide at baseline. At each 4-month interval visit, the investigator will assess whether persistent or recurrent DME is present that warrants retreatment with the randomization assigned treatment. Retreatment, when indicated, will be performed within four weeks after the follow-up visit. Retreatment should not be performed sooner than 3.5 months from the time of the last treatment.
4mg triamcinolone acetonide
4mg intravitreal triamcinolone acetonide injection at baseline. At each 4-month interval visit, the investigator will assess whether persistent or recurrent DME is present that warrants retreatment with the randomization assigned treatment. Retreatment, when indicated, will be performed within four weeks after the follow-up visit. Retreatment should not be performed sooner than 3.5 months from the time of the last treatment.
The New York Eye and Ear Infirmary/Faculty Eye Practice, New York
Retina Consultants, PLLC, Slingerlands
Retina-Vitreous Surgeons of Central New York, PC, Syracuse
University of Rochester, Rochester
Penn State College of Medicine, Hershey
University of Pennsylvania Scheie Eye Institute, Philadelphia
Elman Retina Group, P.A., Baltimore
Retina Consultants of Delmarva, P.A., Salisbury
Wake Forest University Eye Center, Winston-Salem
University of North Carolina, Dept. of Ophthalmology, Chapel Hill
Charlotte Eye Ear Nose and Throat Assoc, PA, Charlotte
Horizon Eye Care, PA, Charlotte
Palmetto Retina Center, Columbia
Carolina Retina Center, Columbia
Southeast Retina Center, P.C., Augusta
Retina Group of Florida, Fort Lauderdale
International Eye Center, Tampa
Central Florida Retina Institute, Lakeland
Florida Retina Consultants, Lakeland
National Ophthalmic Research Institute, Fort Myers
Sarasota Retina Institute, Sarasota
Vanderbilt University Medical Center, Nashville
Southeastern Retina Associates, P.C., Knoxville
Paducah Retinal Center, Paducah
OSU Eye Physicians and Surgeons, LLC., Dublin
Case Western Reserve University, Cleveland
Retina Associates of Cleveland, Inc., Beachwood
Raj K. Maturi, M.D., P.C., Indianapolis
John-Kenyon American Eye Institute, New Albany
Vision Research Foundation, Royal Oak
Henry Ford Health System, Dept of Ophthalmology and Eye Care Services, Detroit
Associated Retinal Consultants, Grand Rapids
Medical College of Wiconsin, Milwaukee
University of Wisconsin-Madison, Dept. of Ophthalmology, Madison
Retina Center, PA, Minneapolis
University of Minnesota, Minneapolis
Black Hills Regional Eye Institute, Rapid City
Illinois Retina Associates, Joliet
Northwestern Medical Faculty Foundation, Chicago
Rush University Medical Center, Chicago
St. Louis University Eye Institute, St Louis
Barnes Retina Institute, St Louis
Dean A. McGee Eye Institute, Oklahoma City
Texas Retina Associates, Dallas
Texas Retina Associates, Arlington
Charles A. Garcia, PA & Associates, Houston
Retina and Vitreous of Texas, Houston
Retina Consultants of Houston, PA, Houston
Valley Retina Institute, McAllen
Retina Research Center, Austin
Texas Retina Associates, Lubbock
West Texas Retina Consultants P.A., Abilene
Eldorado Retina Associates, P.C., Louisville
Denver Health Medical Center, Denver
Rocky Mountain Retina Consultants, Salt Lake City
Doheny Eye Institute, Los Angeles
Jules Stein Eye Institute, Los Angeles
Retina-Vitreous Associates Medical Group, Beverly Hills
SCPMG Regional Offices - Kaiser Permanente, Baldwin Park
Southern California Desert Retina Consultants, MC, Palm Springs
Loma Linda University Health Care, Dept. of Ophthalmology, Loma Linda
University of California, Irvine, Irvine
Orange County Retina Medical Group, Santa Ana
California Retina Consultants, Santa Barbara
West Coast Retina Medical Group, Inc., San Francisco
Bay Area Retina Associates, Walnut Creek
Retina Consultants of Hawaii, Inc., ‘Aiea
Retina Associates of Hawaii, Inc., Honolulu
Retina Northwest, PC, Portland
Casey Eye Institute, Portland
University of Washington Medical Center, Seattle
Jones Eye Institute/University of Arkansas for Medical Sciences, Little Rock
Connecticut Retina Consultants, New Haven
Connecticut Retina Consultants, New Haven
Retina and Vitreous Associates of Kentucky, Lexington
Maine Vitreoretinal Consultants, Bangor
Wilmer Ophthalmological Institute at Johns Hopkins, Baltimore
The Retina Group of Washington, Greenbelt
Ophthalmic Consultants of Boston, Boston
Joslin Diabetes Center, Boston
Kresge Eye Institute, Detroit
Delaware Valley Retina Associates, Lawrenceville
Retina Consultants, Providence
University of Texas Medical Branch, Dept of Ophthalmology and Visual Sciences, Galveston
Lead Sponsor
Collaborators (1)
National Eye Institute (NEI)
NIH
Allergan
INDUSTRY
Jaeb Center for Health Research
OTHER