Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04757636
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2021-02-12
Brief Title:
OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration nAMD
Sponsor:
Opthea Limited
Organization:
Opthea Limited
Study Overview
Official Title:
A Phase 3 Multicentre Double-masked Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Aflibercept Compared With Aflibercept Alone in Participants With nAMD
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
COAST
Brief Summary:
A 2-year phase 3 multicentre randomised parallel-group sham-controlled double-masked study Primary efficacy will be determined at Week 52
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