Clinical trial
Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With…
NCT00344968 · Alimera Sciences, Industry · Completed
Key facts
| NCT number | NCT00344968 |
|---|---|
| Title | Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema |
| Official title | A Randomized, Double-Masked, Parallel Group, Multi-center, Dose-Finding Comparison of the Safety and Efficacy of ASI-001A 0.5 μg/Day and ASI-001B 0.2 μg/Day Fluocinolone Acetonide Intravitreal Inserts to Sham Injection in Subjects With Diabetic Macular Edema |
| Acronym | FAME |
| Lead sponsor | Alimera Sciences, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Diabetic Macular Edema |
| Intervention type | Drug, Procedure |
| Interventions | fluocinolone acetonide, Fluocinolone Acetonide, Standard of care laser photocoagulation |
| Enrollment | 956 |
| Start date | Sep 1, 2007 |
| Primary completion | Dec 1, 2009 |
| Completion | Dec 1, 2010 |
| First posted | Jun 27, 2006 |
| Last update posted | May 7, 2014 |
| Countries | United States |
At a glance
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About ClinicalTrials.gov studies
ClinicalTrials.gov is the U.S. National Library of Medicine's registry of clinical studies conducted around the world. Contact and investigator details are not shown here.
Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: