The study involves the enrollment of patients over 18 years of age with diabetic macular
edema(DME). Patients with one study eye will be randomly assigned (stratified by visual
acuity and prior laser) with equal probability to one of the three treatment groups:
1. Laser photocoagulation
2. 1mg intravitreal triamcinolone acetonide injection
3. 4mg intravitreal triamcinolone acetonide injection
For patients with two study eyes (both eyes eligible at the time of randomization), the
right eye (stratified by visual acuity and prior laser) will be randomly assigned with equal
probabilities to one of the three treatment groups listed above. The left eye will be
assigned to the alternative treatment (laser or triamcinolone). If the left eye is assigned
to triamcinolone, then the dose (1mg or 4 mg) will be randomly assigned to the left eye with
equal probability (stratified by visual acuity and prior laser).
The study drug, triamcinolone acetonide, has been manufactured as a sterile intravitreal
injectable by Allergan. Study eyes assigned to an intravitreal triamcinolone injection will
receive a dose of either 1mg or 4mg. There is no indication of which treatment regimen will
be better.
Patients enrolled into the study will be followed for three years and will have study visits
every 4 months after receiving their assigned study treatment. In addition, standard of care
post-treatment visits will be performed at 4 weeks after each intravitreal injection.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Jones Eye Institute/University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205-7199, United States
SCPMG Regional Offices - Kaiser Permanente, Baldwin Park, California 91706, United States
Retina-Vitreous Associates Medical Group, Beverly Hills, California 90211, United States
University of California, Irvine, Irvine, California 92697, United States
Loma Linda University Health Care, Dept. of Ophthalmology, Loma Linda, California 92354, United States
Doheny Eye Institute, Los Angeles, California 90033, United States
Jules Stein Eye Institute, Los Angeles, California 90095, United States
Southern California Desert Retina Consultants, MC, Palm Springs, California 92262, United States
West Coast Retina Medical Group, Inc., San Francisco, California 94107, United States
Orange County Retina Medical Group, Santa Ana, California 92705, United States
California Retina Consultants, Santa Barbara, California 93103, United States
Bay Area Retina Associates, Walnut Creek, California 94598, United States
Denver Health Medical Center, Denver, Colorado 80204, United States
Eldorado Retina Associates, P.C., Louisville, Colorado 80027, United States
Connecticut Retina Consultants, New Haven, Connecticut 06519-1600, United States
Connecticut Retina Consultants, New Haven, Connecticut 06519, United States
National Ophthalmic Research Institute, Fort Myers, Florida 33912, United States
Retina Group of Florida, Ft. Lauderdale, Florida 33334, United States
Central Florida Retina Institute, Lakeland, Florida 33805, United States
Florida Retina Consultants, Lakeland, Florida 33805, United States
Sarasota Retina Institute, Sarasota, Florida 34239, United States
International Eye Center, Tampa, Florida 33603, United States
Southeast Retina Center, P.C., Augusta, Georgia 30909, United States
Retina Consultants of Hawaii, Inc., Aiea, Hawaii 96701, United States
Retina Associates of Hawaii, Inc., Honolulu, Hawaii 96813, United States
Northwestern Medical Faculty Foundation, Chicago, Illinois 60611, United States
Rush University Medical Center, Chicago, Illinois 60612, United States
Illinois Retina Associates, Joliet, Illinois 60435, United States
Raj K. Maturi, M.D., P.C., Indianapolis, Indiana 46290, United States
John-Kenyon American Eye Institute, New Albany, Indiana 47150, United States
Retina and Vitreous Associates of Kentucky, Lexington, Kentucky 40509-1802, United States
Paducah Retinal Center, Paducah, Kentucky 42001, United States
Maine Vitreoretinal Consultants, Bangor, Maine 04401, United States
Elman Retina Group, P.A., Baltimore, Maryland 21237, United States
Wilmer Ophthalmological Institute at Johns Hopkins, Baltimore, Maryland 21287-9277, United States
The Retina Group of Washington, Greenbelt, Maryland 20770-3502, United States
Retina Consultants of Delmarva, P.A., Salisbury, Maryland 21801, United States
Joslin Diabetes Center, Boston, Massachusetts 02215, United States
Ophthalmic Consultants of Boston, Boston, Massachusetts 02114, United States
Henry Ford Health System, Dept of Ophthalmology and Eye Care Services, Detroit, Michigan 48202, United States
Kresge Eye Institute, Detroit, Michigan 48201-1423, United States
Associated Retinal Consultants, Grand Rapids, Michigan 49546, United States
Vision Research Foundation, Royal Oak, Michigan 48073, United States
Retina Center, PA, Minneapolis, Minnesota 55404, United States
University of Minnesota, Minneapolis, Minnesota 55455, United States
Barnes Retina Institute, St. Louis, Missouri 63110, United States
St. Louis University Eye Institute, St. Louis, Missouri 63104, United States
Delaware Valley Retina Associates, Lawrenceville, New Jersey 08648, United States
The New York Eye and Ear Infirmary/Faculty Eye Practice, New York, New York 10003, United States
University of Rochester, Rochester, New York 14642, United States
Retina Consultants, PLLC, Slingerlands, New York 12159, United States
Retina-Vitreous Surgeons of Central New York, PC, Syracuse, New York 13224, United States
University of North Carolina, Dept. of Ophthalmology, Chapel Hill, North Carolina 27599, United States
Charlotte Eye Ear Nose and Throat Assoc, PA, Charlotte, North Carolina 28210, United States
Horizon Eye Care, PA, Charlotte, North Carolina 28211, United States
Wake Forest University Eye Center, Winston-Salem, North Carolina 27157, United States
Retina Associates of Cleveland, Inc., Beachwood, Ohio 44122, United States
Case Western Reserve University, Cleveland, Ohio 44106, United States
OSU Eye Physicians and Surgeons, LLC., Dublin, Ohio 43017, United States
Dean A. McGee Eye Institute, Oklahoma City, Oklahoma 73104, United States
Casey Eye Institute, Portland, Oregon 97239, United States
Retina Northwest, PC, Portland, Oregon 97210, United States
Penn State College of Medicine, Hershey, Pennsylvania 17033, United States
University of Pennsylvania Scheie Eye Institute, Philadelphia, Pennsylvania 19104, United States
Retina Consultants, Providence, Rhode Island 02903, United States
Carolina Retina Center, Columbia, South Carolina 29223, United States
Palmetto Retina Center, Columbia, South Carolina 29169, United States
Black Hills Regional Eye Institute, Rapid City, South Dakota 57701, United States
Southeastern Retina Associates, P.C., Knoxville, Tennessee 37909, United States
Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States
West Texas Retina Consultants P.A., Abilene, Texas 79605, United States
Texas Retina Associates, Arlington, Texas 76012, United States
Retina Research Center, Austin, Texas 78705, United States
Texas Retina Associates, Dallas, Texas 75231, United States
University of Texas Medical Branch, Dept of Ophthalmology and Visual Sciences, Galveston, Texas 77555-1106, United States
Charles A. Garcia, PA & Associates, Houston, Texas 77002, United States
Retina and Vitreous of Texas, Houston, Texas 77025, United States
Retina Consultants of Houston, PA, Houston, Texas 77030, United States
Texas Retina Associates, Lubbock, Texas 79424, United States
Valley Retina Institute, McAllen, Texas 78503, United States
Rocky Mountain Retina Consultants, Salt Lake City, Utah 84107, United States
University of Washington Medical Center, Seattle, Washington 98195, United States
University of Wisconsin-Madison, Dept. of Ophthalmology, Madison, Wisconsin 53705, United States
Medical College of Wiconsin, Milwaukee, Wisconsin 53226, United States