Viewing Study NCT04757636



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