Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05748873
Status:
RECRUITING
Last Update Posted:
2023-06-01
First Post:
2023-02-07
Brief Title:
Promising ROd-cone DYstrophy Gene TherapY
Sponsor:
SparingVision
Organization:
SparingVision
Study Overview
Official Title:
A Phase III Study to Assess the Safety and Tolerability of a Single Subretinal Administration of SPVN06 Gene Therapy in Subjects with Rod-Cone Dystrophy RCD Due to a Mutation in the RHO PDE6A or PDE6B Gene
Status:
RECRUITING
Status Verified Date:
2024-09
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:
PRODYGY
Brief Summary:
This is a two-step multicenter Phase III study including an open-label dose-escalation phase Step 1 and a three-arm controlled double-masked randomized extension phase Step 2 in subjects with advanced RCD due to a mutation in the RHO PDE6A or PDE6B gene
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?:
True
Is an FDA AA801 Violation?:
None