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NCT00168389 · ClinicalTrials.gov registry record · Phase 3
A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema
A Phase 3 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 3
- Development phase
- 494
- Enrollment target
NCT00168389: Completed Phase 3 study, sponsored by Allergan.
NCT00168389 is a Phase 3 study that has completed, run by Allergan. The registered enrollment target is 494 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00168389, a Phase 3 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 494 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.
Primary Outcome
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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
- OTHER Sham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 494 participants |
| Start Date | 2005-02 |
| Est. Completion | 2012-06 |
| Phase | Phase 3 |
What the finished NCT00168389 record still lists
NCT00168389 is an interventional study that assigns participants to a tested intervention. The registered 494 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 (36% lower).
The record links to 0 conditions, and to 2 interventions - of which Dexamethasone is the first listed.
NCT00168389 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00168389 about?
NCT00168389 is a clinical study titled "A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema". This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.
What is the current status of trial NCT00168389?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 494 participants. The study started on 2005-02. Estimated completion is 2012-06.
What interventions are being tested in trial NCT00168389?
The interventions under investigation include: Dexamethasone (DRUG), Sham (OTHER).
Who is sponsoring clinical trial NCT00168389?
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 NCT00168389's enrollment target sits among peer trials
494 779th of 2000 higher than 1,222 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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