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NCT00464685 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema
A Phase 2 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 2
- Development phase
- 253
- Enrollment target
NCT00464685: Completed Phase 2 study, sponsored by Allergan.
NCT00464685 is a Phase 2 study that has completed, run by Allergan. The registered enrollment target is 253 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00464685, a Phase 2 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 253 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs. laser treatment alone in patients with diabetic macular edema.
Primary Outcome
BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
Interventions
- DRUG Dexamethasone
- DRUG Sham injection
- PROCEDURE Laser Photocoagulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 253 participants |
| Start Date | 2007-05-01 |
| Est. Completion | 2010-02-08 |
| Phase | Phase 2 |
What the finished NCT00464685 record still lists
NCT00464685 is an interventional study that assigns participants to a tested intervention. The registered 253 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% higher).
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT00464685 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00464685 about?
NCT00464685 is a clinical study titled "Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema". This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs. laser treatment alone in patients with diabetic macular edema.
What is the current status of trial NCT00464685?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 253 participants. The study started on 2007-05-01. Estimated completion is 2010-02-08.
What interventions are being tested in trial NCT00464685?
The interventions under investigation include: Dexamethasone (DRUG), Sham injection (DRUG), Laser Photocoagulation (PROCEDURE).
Who is sponsoring clinical trial NCT00464685?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00464685's enrollment target sits among peer trials
253 220th of 2000 higher than 1,781 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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