Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-03-06 @ 1:35 PM
Study NCT ID:
NCT01889251
Status:
COMPLETED
Last Update Posted:
2015-11-30
First Post:
2013-06-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase III Study of A01016 in Subjects With Symptomatic Vitreomacular Adhesion
Sponsor:
Alcon Research
Organization:
Study Overview
Official Title:
A Phase III Study of A01016 125μg Intravitreal Injection in Subjects With Symptomatic Vitreomacular Adhesion - Comparison Study to Sham Injection
Status:
COMPLETED
Status Verified Date:
2015-11
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:
The purpose of this study is to evaluate the superiority regarding vitreomacular adhesion (VMA) resolution of a single intravitreal injection of A01016 (Ocriplasmin) compared to sham-injection in subjects with symptomatic VMA.
Detailed Description:
None
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?: