Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT05571267
Status:
TERMINATED
Last Update Posted:
2025-03-13
First Post:
2022-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety Study of Zimura in Combination With Anti-VEGF Therapy in Patients With Neovascular AMD
Sponsor:
IVERIC bio, Inc.
Organization:
Study Overview
Official Title:
A Phase 2A Randomized Open-Label Controlled Trial to Assess the Safety of Zimura™ (Anti-C5 Aptamer) Administered in Combination With Anti-VEGF Therapy in Treatment Experienced Patients With Neovascular Age-Related Macular Degeneration
Status:
TERMINATED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Following Sponsor reassessment, OPH2004 enrollment was stopped to initiate a new Zimura wet AMD trial, OPH2007, for treatment-naïve patients. Thus, only one patient was enrolled into and completed Study OPH2004.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to assess the safety of intravitreal (IVT) Zimura® administered in combination with anti-VEGF Therapy (AVASTIN®, EYLEA®, OR LUCENTIS®) in anti-VEGF treatment experienced subjects with neovascular age-related macular degeneration (AMD)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: