Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT01602120
Status:
TERMINATED
Last Update Posted:
2019-09-11
First Post:
2012-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
An Extension Study to Evaluate the Long-Term Safety of Lampalizumab in Participants With Geographic Atrophy
Sponsor:
Genentech, Inc.
Organization:
Study Overview
Official Title:
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab (FCFD4514S) in Patients With Geographic Atrophy Who Have Completed Genentech-Sponsored Lampalizumab Studies
Status:
TERMINATED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated early by the Sponsor due to lack of efficacy.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter, open-label extension study of safety and tolerability of lampalizumab administered by intravitreal (ITV) injection to participants with geographic atrophy (GA) who have completed the 18-month treatment in Study CFD4870g (GX01456) (NCT01229215) or 24-week treatment in Study GX29455 (NCT02288559).
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012-000578-41 | EUDRACT_NUMBER | None | View |