Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-29 @ 5:33 PM
Study NCT ID:
NCT00344968
Status:
COMPLETED
Last Update Posted:
2014-05-07
First Post:
2006-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema
Sponsor:
Alimera Sciences
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FAME
Brief Summary:
This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: