Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-01 @ 9:08 AM
Study NCT ID:
NCT02686658
Status:
COMPLETED
Last Update Posted:
2025-06-10
First Post:
2016-02-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
Sponsor:
IVERIC bio, Inc.
Organization:
Study Overview
Official Title:
A Phase 2/3 Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™ (Anti-C5 Aptamer) in Patients With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2025-05
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:
The objectives of this study were to evaluate the safety and efficacy of Zimura intravitreal (IVT) administration when administered in participants with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).
Detailed Description:
Participants will receive monthly intravitreal injections of Zimura or Sham for 18 months.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2015-003991-56 | EUDRACT_NUMBER | None | View |