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NCT00367133 · ClinicalTrials.gov registry record · Phase 3
Intravitreal Triamcinolone Acetonide Versus Laser for Diabetic Macular Edema
A Phase 3 study, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 840
- Enrollment target
NCT00367133: Completed Phase 3 study, sponsored by Jaeb Center for Health Research.
NCT00367133 is a Phase 3 study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 840 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00367133, a Phase 3 study, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 840 participants
- Enrollment target
Study 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 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.
Primary Outcome
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.
Interventions
- PROCEDURE Standard of Care Group
- DRUG 1mg triamcinolone acetonide
- DRUG 4mg triamcinolone acetonide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 840 participants |
| Start Date | 2004-07 |
| Est. Completion | 2008-10 |
| Phase | Phase 3 |
What the finished NCT00367133 record still lists
NCT00367133 is an interventional study that assigns participants to a tested intervention. The registered 840 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Standard of Care Group is the first listed.
NCT00367133 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00367133 about?
NCT00367133 is a clinical study titled "Intravitreal Triamcinolone Acetonide Versus Laser for Diabetic Macular Edema". 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 intr...
What is the current status of trial NCT00367133?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 840 participants. The study started on 2004-07. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00367133?
The interventions under investigation include: Standard of Care Group (PROCEDURE), 1mg triamcinolone acetonide (DRUG), 4mg triamcinolone acetonide (DRUG).
Who is sponsoring clinical trial NCT00367133?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00367133's enrollment target sits among peer trials
840 392nd of 2000 higher than 1,607 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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