Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04770545
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2021-02-23
Brief Title:
An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan APL-2 in Subjects With Geographic Atrophy Secondary to AMD
Sponsor:
Apellis Pharmaceuticals Inc
Organization:
Apellis Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 3 Open-Label Multicenter Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegcetacoplan in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GALE
Brief Summary:
This is a phase 3 open-label multicenter extension study to evaluate the long-term safety and efficacy of pegcetacoplan APL-2 in subjects with geographic atrophy GA secondary to age-related macular degeneration AMD who participated in Study APL2-103 NCT03777332 or completed the treatment at Month 24 of either Study APL2-303 Derby NCT03525613 or Study APL2-304 Oaks NCT03525600
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None