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NCT00344968 · ClinicalTrials.gov registry record · Phase 3
Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema
A Phase 3 study, sponsored by Alimera Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 956
- Enrollment target
NCT00344968: Completed Phase 3 study, sponsored by Alimera Sciences.
NCT00344968 is a Phase 3 study that has completed, run by Alimera Sciences. The registered enrollment target is 956 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00344968, a Phase 3 study, has completed, sponsored by Alimera Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 956 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema.
Primary Outcome
The percentage of subjects with an increase from baseline of 15 or more letters in best corrected visual acuity letter score as assessed by ETDRS eye chart (study eye).
Interventions
- DRUG fluocinolone acetonide
- DRUG Fluocinolone Acetonide
- PROCEDURE Standard of care laser photocoagulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 956 participants |
| Start Date | 2007-09 |
| Est. Completion | 2010-12 |
| Phase | Phase 3 |
What the finished NCT00344968 record still lists
NCT00344968 is an interventional study that assigns participants to a tested intervention. The registered 956 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (24% higher).
The record links to 0 conditions, and to 3 interventions - of which fluocinolone acetonide is the first listed.
NCT00344968 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00344968 about?
NCT00344968 is a clinical study titled "Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema". This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema.
What is the current status of trial NCT00344968?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 956 participants. The study started on 2007-09. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00344968?
The interventions under investigation include: fluocinolone acetonide (DRUG), Fluocinolone Acetonide (DRUG), Standard of care laser photocoagulation (PROCEDURE).
Who is sponsoring clinical trial NCT00344968?
This trial is sponsored by Alimera Sciences, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00344968's enrollment target sits among peer trials
956 333rd of 2000 higher than 1,668 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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