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NCT00444600 · ClinicalTrials.gov registry record · Phase 3
Laser-Ranibizumab-Triamcinolone for Diabetic Macular Edema
A Phase 3 study, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 691
- Enrollment target
NCT00444600: Completed Phase 3 study, sponsored by Jaeb Center for Health Research.
NCT00444600 is a Phase 3 study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 691 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00444600, a Phase 3 study, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 691 participants
- Enrollment target
Study Summary
The purpose of the study is to find out which is a better treatment for diabetic macular edema (DME): laser alone, laser combined with an intravitreal injection of triamcinolone, laser combined with an intravitreal injection of ranibizumab, or intravitreal injection of ranibizumab alone. At the present time, it is not known whether intravitreal steroid or anti-vascular endothelial growth factor (anti-VEGF) injections, with or without laser treatment, are better than just laser by itself. It is possible that one or both of the types of injections, with or without laser treatment, will improve vision more often than will laser without injections. However, even if better vision outcomes are seen with injections, side effects may be more of a problem with the injections than with laser. Therefore, this study is conducted to find out whether the benefits of the injections will outweigh the risks.
Primary Outcome
Change in best correct visual acuity letter score from baseline to one year 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
- DRUG Triamcinolone Acetonide + laser
- DRUG Ranibizumab + laser
- DRUG Sham injection + laser
- DRUG Ranibizumab + deferred laser
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 691 participants |
| Start Date | 2007-03 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
What the finished NCT00444600 record still lists
NCT00444600 is an interventional study that assigns participants to a tested intervention. The registered 691 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 4 interventions - of which Triamcinolone Acetonide + laser is the first listed.
NCT00444600 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00444600 about?
NCT00444600 is a clinical study titled "Laser-Ranibizumab-Triamcinolone for Diabetic Macular Edema". The purpose of the study is to find out which is a better treatment for diabetic macular edema (DME): laser alone, laser combined with an intravitreal injection of triamcinolone, laser combined with an intravitreal injection of ranibizumab, or intravitreal injection of ranibizumab alone. At the pres...
What is the current status of trial NCT00444600?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 691 participants. The study started on 2007-03. Estimated completion is 2014-02.
What interventions are being tested in trial NCT00444600?
The interventions under investigation include: Triamcinolone Acetonide + laser (DRUG), Ranibizumab + laser (DRUG), Sham injection + laser (DRUG), Ranibizumab + deferred laser (DRUG).
Who is sponsoring clinical trial NCT00444600?
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 NCT00444600's enrollment target sits among peer trials
691 524th of 2000 higher than 1,477 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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