Ignite Creation Date:
2024-07-17 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492850
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Brief Title:
Gene Therapy for RPGR Gene Mutation-associated X-linked Retinitis Pigmentosa
Sponsor:
Frontera Therapeutics
Organization:
Frontera Therapeutics
Study Overview
Official Title:
A Phase III Dose-escalation and Dose-expansion Study to Evaluate the Safety and Efficacy of FT-002 Subretinal Injection in Subjects With RPGR Gene Mutation-associated X-linked Retinitis Pigmentosa
Status:
RECRUITING
Status Verified Date:
2024-07
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 aim of this study was to evaluate the safety tolerability and efficacy of one-time subretinal injection of FT-002 in male subjects 8-45 years of age with RPGR Retinitis Pigmentosa GTPase Regulator gene mutation-associated X-linked retinitis pigmentosa of XLRP This study includes Phase I dose escalation phase and Phase II dose expansion phase
Detailed Description:
None
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