Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT00695318
Status:
TERMINATED
Last Update Posted:
2015-05-29
First Post:
2008-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy
Sponsor:
Alimera Sciences
Organization:
Study Overview
Official Title:
A Randomized, Double-Masked, Fellow-Eye Comparison Of The Safety And Efficacy Of 0.2 And 0.5 µg/Day Fluocinolone Acetonide Intravitreal Insert To Sham Injection In Subjects With Bilateral Geographic Atrophy Due To AMD
Status:
TERMINATED
Status Verified Date:
2015-05
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:
None
Brief Summary:
This study will compare the safety and efficacy of Medidur FA treatment in one eye to the sham-treated fellow eye of subjects with geographic atrophy secondary to AMD.
Detailed Description:
Each patient received a sham injection in one eye and active treatment in the other eye. The eye receiving active treatment was selected based on a randomization schedule.
Study Oversight
Has Oversight DMC:
False
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?: