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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 is a Phase 3 study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 840 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00367133
The ClinicalTrials.gov registry entry for NCT00367133 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 840 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jaeb Center for Health Research, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Standard of Care Group is the first listed.
NCT00367133 reports 0 study locations.
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.
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