Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06196840
Status:
RECRUITING
Last Update Posted:
2024-01-09
First Post:
2023-12-25
Brief Title:
Safety and Efficacy of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration nAMD VENUS
Sponsor:
Innostellar Biotherapeutics CoLtd
Organization:
Innostellar Biotherapeutics CoLtd
Study Overview
Official Title:
A Phase 2 Randomized Controlled Open-Label Study to Establish the Safety and Efficacy of LX102 in Patients With Neovascular Age-related Macular Degeneration nAMD VENUS
Status:
RECRUITING
Status Verified Date:
2023-12
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 goal of this study is to evaluate the overall safety and efficacy of LX102 gene therapy for nAMD
Detailed Description:
In this Phase 2 multi-center randomized controlled study subjects will be randomized to receive one of the two dose levels of LX102 n20 for each dose level or aflibercept n10
Safety tolerability and efficacy will be evaluated for a period of approximately 1 year from baseline
Safety tolerability and efficacy will be evaluated for a period of approximately 1 year from baseline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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