Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
Study NCT ID:
NCT04435366
Status:
COMPLETED
Last Update Posted:
2025-10-21
First Post:
2020-05-12
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)
Sponsor:
IVERIC bio, Inc.
Organization:
Study Overview
Official Title:
A Phase 3 Multicenter, Randomized, Double Masked, Sham- Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2025-10
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:
None
Brief Summary:
The objectives of this study was to evaluate the safety and efficacy of avacincaptad pegol intravitreal administration in participants with geographic atrophy secondary to age-related macular degeneration (AMD)
Detailed Description:
Participants were randomized in a 1:1 ratio to the following monthly treatment groups:
* Avacincaptad pegol 2 mg
* Sham
At Month 12, the participants in the avacincaptad pegol 2mg treatment group were re-randomized to receive the study drug either on a monthly basis or on an every other month basis
The participants initially randomized to sham treatment continued with monthly sham administration through Month 23
All participants had a final follow up visit at Month 24
* Avacincaptad pegol 2 mg
* Sham
At Month 12, the participants in the avacincaptad pegol 2mg treatment group were re-randomized to receive the study drug either on a monthly basis or on an every other month basis
The participants initially randomized to sham treatment continued with monthly sham administration through Month 23
All participants had a final follow up visit at Month 24
Study Oversight
Has Oversight DMC:
True
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?: