Intravitreal Triamcinolone Acetonide Versus Laser for Diabetic Macular Edema
Public ClinicalTrials.gov record NCT00367133. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for Diabetic Macular Edema
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00367133
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 840 participants
Conditions and interventions
Conditions
Interventions
- Standard of Care Group Procedure
- 1mg triamcinolone acetonide Drug
- 4mg triamcinolone acetonide Drug
Procedure · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2004 (Type not available)
- Primary completion
- May 2008 (Actual)
- Completion
- Oct 2008 (Actual)
- Last update posted
- Aug 26, 2016
2004 – 2008
United States locations
- U.S. sites
- 84
- U.S. states
- 31
- U.S. cities
- 70
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Jones Eye Institute/University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205-7199 | — |
| SCPMG Regional Offices - Kaiser Permanente | Baldwin Park | California | 91706 | — |
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | — |
| University of California, Irvine | Irvine | California | 92697 | — |
| Loma Linda University Health Care, Dept. of Ophthalmology | Loma Linda | California | 92354 | — |
| Doheny Eye Institute | Los Angeles | California | 90033 | — |
| Jules Stein Eye Institute | Los Angeles | California | 90095 | — |
| Southern California Desert Retina Consultants, MC | Palm Springs | California | 92262 | — |
| West Coast Retina Medical Group, Inc. | San Francisco | California | 94107 | — |
| Orange County Retina Medical Group | Santa Ana | California | 92705 | — |
| California Retina Consultants | Santa Barbara | California | 93103 | — |
| Bay Area Retina Associates | Walnut Creek | California | 94598 | — |
| Denver Health Medical Center | Denver | Colorado | 80204 | — |
| Eldorado Retina Associates, P.C. | Louisville | Colorado | 80027 | — |
| Connecticut Retina Consultants | New Haven | Connecticut | 06519-1600 | — |
| Connecticut Retina Consultants | New Haven | Connecticut | 06519 | — |
| Retina Group of Florida | Fort Lauderdale | Florida | 33334 | — |
| National Ophthalmic Research Institute | Fort Myers | Florida | 33912 | — |
| Central Florida Retina Institute | Lakeland | Florida | 33805 | — |
| Florida Retina Consultants | Lakeland | Florida | 33805 | — |
| Sarasota Retina Institute | Sarasota | Florida | 34239 | — |
| International Eye Center | Tampa | Florida | 33603 | — |
| Southeast Retina Center, P.C. | Augusta | Georgia | 30909 | — |
| Retina Associates of Hawaii, Inc. | Honolulu | Hawaii | 96813 | — |
| Retina Consultants of Hawaii, Inc. | ‘Aiea | Hawaii | 96701 | — |
| Northwestern Medical Faculty Foundation | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Illinois Retina Associates | Joliet | Illinois | 60435 | — |
| Raj K. Maturi, M.D., P.C. | Indianapolis | Indiana | 46290 | — |
| John-Kenyon American Eye Institute | New Albany | Indiana | 47150 | — |
| Retina and Vitreous Associates of Kentucky | Lexington | Kentucky | 40509-1802 | — |
| Paducah Retinal Center | Paducah | Kentucky | 42001 | — |
| Maine Vitreoretinal Consultants | Bangor | Maine | 04401 | — |
| Elman Retina Group, P.A. | Baltimore | Maryland | 21237 | — |
| Wilmer Ophthalmological Institute at Johns Hopkins | Baltimore | Maryland | 21287-9277 | — |
| The Retina Group of Washington | Greenbelt | Maryland | 20770-3502 | — |
| Retina Consultants of Delmarva, P.A. | Salisbury | Maryland | 21801 | — |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | — |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | — |
| Kresge Eye Institute | Detroit | Michigan | 48201-1423 | — |
| Henry Ford Health System, Dept of Ophthalmology and Eye Care Services | Detroit | Michigan | 48202 | — |
| Associated Retinal Consultants | Grand Rapids | Michigan | 49546 | — |
| Vision Research Foundation | Royal Oak | Michigan | 48073 | — |
| Retina Center, PA | Minneapolis | Minnesota | 55404 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| St. Louis University Eye Institute | St Louis | Missouri | 63104 | — |
| Barnes Retina Institute | St Louis | Missouri | 63110 | — |
| Delaware Valley Retina Associates | Lawrenceville | New Jersey | 08648 | — |
| The New York Eye and Ear Infirmary/Faculty Eye Practice | New York | New York | 10003 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Retina Consultants, PLLC | Slingerlands | New York | 12159 | — |
| Retina-Vitreous Surgeons of Central New York, PC | Syracuse | New York | 13224 | — |
| University of North Carolina, Dept. of Ophthalmology | Chapel Hill | North Carolina | 27599 | — |
| Charlotte Eye Ear Nose and Throat Assoc, PA | Charlotte | North Carolina | 28210 | — |
| Horizon Eye Care, PA | Charlotte | North Carolina | 28211 | — |
| Wake Forest University Eye Center | Winston-Salem | North Carolina | 27157 | — |
| Retina Associates of Cleveland, Inc. | Beachwood | Ohio | 44122 | — |
| Case Western Reserve University | Cleveland | Ohio | 44106 | — |
| OSU Eye Physicians and Surgeons, LLC. | Dublin | Ohio | 43017 | — |
| Dean A. McGee Eye Institute | Oklahoma City | Oklahoma | 73104 | — |
| Retina Northwest, PC | Portland | Oregon | 97210 | — |
| Casey Eye Institute | Portland | Oregon | 97239 | — |
| Penn State College of Medicine | Hershey | Pennsylvania | 17033 | — |
| University of Pennsylvania Scheie Eye Institute | Philadelphia | Pennsylvania | 19104 | — |
| Retina Consultants | Providence | Rhode Island | 02903 | — |
| Palmetto Retina Center | Columbia | South Carolina | 29169 | — |
| Carolina Retina Center | Columbia | South Carolina | 29223 | — |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | — |
| Southeastern Retina Associates, P.C. | Knoxville | Tennessee | 37909 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| West Texas Retina Consultants P.A. | Abilene | Texas | 79605 | — |
| Texas Retina Associates | Arlington | Texas | 76012 | — |
| Retina Research Center | Austin | Texas | 78705 | — |
| Texas Retina Associates | Dallas | Texas | 75231 | — |
| University of Texas Medical Branch, Dept of Ophthalmology and Visual Sciences | Galveston | Texas | 77555-1106 | — |
| Charles A. Garcia, PA & Associates | Houston | Texas | 77002 | — |
| Retina and Vitreous of Texas | Houston | Texas | 77025 | — |
| Retina Consultants of Houston, PA | Houston | Texas | 77030 | — |
| Texas Retina Associates | Lubbock | Texas | 79424 | — |
| Valley Retina Institute | McAllen | Texas | 78503 | — |
| Rocky Mountain Retina Consultants | Salt Lake City | Utah | 84107 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
| University of Wisconsin-Madison, Dept. of Ophthalmology | Madison | Wisconsin | 53705 | — |
| Medical College of Wiconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00367133, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 26, 2016 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00367133 live on ClinicalTrials.gov.