Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344968
Status:
COMPLETED
Last Update Posted:
2014-05-07
First Post:
2006-06-26
Brief Title:
Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema
Sponsor:
Alimera Sciences
Organization:
Alimera Sciences
Study Overview
Official Title:
A Randomized Double-Masked Parallel Group Multi-center Dose-Finding Comparison of the Safety and Efficacy of ASI-001A 05 μgDay and ASI-001B 02 μgDay 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None