Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
Study NCT ID:
NCT06190093
Status:
COMPLETED
Last Update Posted:
2025-02-25
First Post:
2023-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects with Neovascular Age-related Macular Degeneration (AMD)
Sponsor:
Outlook Therapeutics, Inc.
Organization:
Study Overview
Official Title:
Safety and Effectiveness of ONS-5010 Compared to Lucentis® in Subjects with Neovascular Age-related Macular Degeneration; NORSE EIGHT
Status:
COMPLETED
Status Verified Date:
2025-02
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:
Multicenter, randomized, masked, controlled study of the safety and effectiveness of intravitreally administered ONS-5010.
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?:
False
Is an FDA AA801 Violation?: