Intravitreal Triamcinolone Acetonide Versus Laser for Diabetic Macular Edema
IVT
A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for Diabetic Macular Edema
4 other identifiers
interventional
840
1 country
84
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2004
Typical duration for phase_3
84 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 3, 2006
CompletedFirst Posted
Study publicly available on registry
August 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
July 9, 2010
CompletedAugust 26, 2016
August 1, 2016
3.8 years
August 3, 2006
July 14, 2009
August 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change In Visual Acuity [Measured With Electronic-Early Treatment Diabetic Retinopathy Study (E-ETDRS)]Baseline to 2 Years.
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.
Baseline to 2 Years
Median Change in Visual Acuity Baseline to 2 Years
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement.
Baseline to 2 Years
Distribution of Change in Visual Acuity Baseline to 2 Years
Change in best correct visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.
baseline to 2 years
Secondary Outcomes (11)
Central Subfield Thickness at 2 Years
2 Years
Mean Change in Central Subfield Thickness Baseline to 2 Years
Baseline to 2 years
Median Change in Central Subfield Thickness Baseline to 2 Years
Baseline to 2 Years
Overall Central Subfield Thickening Decreased by >=50% Baseline to 2 Years
Baseline to 2 Years
Central Subfield Thickness < 250 Microns at 2 Years
2 Years
- +6 more secondary outcomes
Study Arms (3)
1
ACTIVE COMPARATORStandard of care group: conventional treatment consisting of focal/grid photocoagulation.
2
EXPERIMENTALIntravitreal injection of 1mg of triamcinolone acetonide
3
EXPERIMENTALIntravitreal injection of 4mg of triamcinolone acetonide
Interventions
Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
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 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.
Eligibility Criteria
You may qualify if:
- Age ≥18 years
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Able and willing to provide informed consent.
- Patient understands that (1) if both eyes are eligible at the time of randomization, one eye will receive intravitreal triamcinolone acetonide and one eye will receive laser, and (2) if only one eye is eligible at the time of randomization and the fellow eye develops DME later, then the fellow eye will not receive intravitreal triamcinolone acetonide if the study eye received intravitreal triamcinolone acetonide (however, if the study eye was assigned to the laser group, then the fellow eye may be treated with the 4mg dose of the study intravitreal triamcinolone acetonide formulation, provided the eye assigned to laser has not received an intravitreal injection; such an eye will not be a "study eye" but since it is receiving study drug, it will be followed for adverse effects).
You may not qualify if:
- \. History of chronic renal failure requiring dialysis or kidney transplant.
- \. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control). Note: Patients in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled.
- \. Participation in an investigational trial within 30 days of study entry that involved treatment with any drug that has not received regulatory approval at the time of study entry.
- \. Known allergy to any corticosteroid or any component of the delivery vehicle.
- \. History of systemic (e.g., oral, IV, IM, epidural, bursal) corticosteroids within 4 months prior to randomization or topical, rectal, or inhaled corticosteroids in current use more than 2 times per week.
- \. Patient is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the 3 years of the study.
- \. Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110). Note: If blood pressure is brought below 180/110 by anti-hypertensive treatment, patient can become eligible.
- Study Eye Eligibility
- Best corrected Electronic-Early Treatment Diabetic Retinopathy Study (e-ETDRS) visual acuity score of ≥ 24 letters (i.e., 20/320 or better) and ≤73 letters (i.e., 20/40 or worse).
- Definite retinal thickening due to diabetic macular edema based on clinical exam involving the center of the macula.
- Mean retinal thickness on two Optical Coherence Tomography (OCT) measurements ≥250 microns in the central subfield.
- Media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs.
- Macular edema is considered to be due to a cause other than diabetic macular edema.
- An ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary changes, dense subfoveal hard exudates, nonretinal condition).
- An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.)
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jaeb Center for Health Researchlead
- National Eye Institute (NEI)collaborator
- Allergancollaborator
Study Sites (84)
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
Retina Group of Florida
Fort Lauderdale, Florida, 33334, United States
National Ophthalmic Research Institute
Fort Myers, Florida, 33912, 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 Associates of Hawaii, Inc.
Honolulu, Hawaii, 96813, United States
Retina Consultants of Hawaii, Inc.
‘Aiea, Hawaii, 96701, 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
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Kresge Eye Institute
Detroit, Michigan, 48201-1423, United States
Henry Ford Health System, Dept of Ophthalmology and Eye Care Services
Detroit, Michigan, 48202, 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
St. Louis University Eye Institute
St Louis, Missouri, 63104, United States
Barnes Retina Institute
St Louis, Missouri, 63110, 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
Retina Northwest, PC
Portland, Oregon, 97210, United States
Casey Eye Institute
Portland, Oregon, 97239, 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
Palmetto Retina Center
Columbia, South Carolina, 29169, United States
Carolina Retina Center
Columbia, South Carolina, 29223, 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
Related Publications (8)
Bhavsar AR, Ip MS, Glassman AR; DRCRnet and the SCORE Study Groups. The risk of endophthalmitis following intravitreal triamcinolone injection in the DRCRnet and SCORE clinical trials. Am J Ophthalmol. 2007 Sep;144(3):454-6. doi: 10.1016/j.ajo.2007.04.011.
PMID: 17765429RESULTIp MS, Bressler SB, Antoszyk AN, Flaxel CJ, Kim JE, Friedman SM, Qin H; Diabetic Retinopathy Clinical Research Network. A randomized trial comparing intravitreal triamcinolone and focal/grid photocoagulation for diabetic macular edema: baseline features. Retina. 2008 Jul-Aug;28(7):919-30. doi: 10.1097/IAE.0b013e31818144a7.
PMID: 18698292RESULTDiabetic Retinopathy Clinical Research Network. A randomized trial comparing intravitreal triamcinolone acetonide and focal/grid photocoagulation for diabetic macular edema. Ophthalmology. 2008 Sep;115(9):1447-9, 1449.e1-10. doi: 10.1016/j.ophtha.2008.06.015. Epub 2008 Jul 26.
PMID: 18662829RESULTDiabetic Retinopathy Clinical Research Network (DRCR.net); Beck RW, Edwards AR, Aiello LP, Bressler NM, Ferris F, Glassman AR, Hartnett E, Ip MS, Kim JE, Kollman C. Three-year follow-up of a randomized trial comparing focal/grid photocoagulation and intravitreal triamcinolone for diabetic macular edema. Arch Ophthalmol. 2009 Mar;127(3):245-51. doi: 10.1001/archophthalmol.2008.610.
PMID: 19273785RESULTAiello LP, Edwards AR, Beck RW, Bressler NM, Davis MD, Ferris F, Glassman AR, Ip MS, Miller KM; Diabetic Retinopathy Clinical Research Network. Factors associated with improvement and worsening of visual acuity 2 years after focal/grid photocoagulation for diabetic macular edema. Ophthalmology. 2010 May;117(5):946-53. doi: 10.1016/j.ophtha.2009.10.002. Epub 2010 Feb 1.
PMID: 20122739RESULTBressler NM, Edwards AR, Beck RW, Flaxel CJ, Glassman AR, Ip MS, Kollman C, Kuppermann BD, Stone TW; Diabetic Retinopathy Clinical Research Network. Exploratory analysis of diabetic retinopathy progression through 3 years in a randomized clinical trial that compares intravitreal triamcinolone acetonide with focal/grid photocoagulation. Arch Ophthalmol. 2009 Dec;127(12):1566-71. doi: 10.1001/archophthalmol.2009.308.
PMID: 20008708RESULTRittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3.
PMID: 33206392DERIVEDGangaputra S, Almukhtar T, Glassman AR, Aiello LP, Bressler N, Bressler SB, Danis RP, Davis MD; Diabetic Retinopathy Clinical Research Network. Comparison of film and digital fundus photographs in eyes of individuals with diabetes mellitus. Invest Ophthalmol Vis Sci. 2011 Aug 3;52(9):6168-73. doi: 10.1167/iovs.11-7321.
PMID: 21571677DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Adam R. Glassman, Director DRCR.net Coordinating Center
- Organization
- Jaeb Center for Health Research
Study Officials
- STUDY CHAIR
Michael Ip, M.D.
University of Wisconsin Medical School
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2006
First Posted
August 22, 2006
Study Start
July 1, 2004
Primary Completion
May 1, 2008
Study Completion
October 1, 2008
Last Updated
August 26, 2016
Results First Posted
July 9, 2010
Record last verified: 2016-08