Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627179
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Study to Evaluate Ultevursen in Subjects with Retinitis Pigmentosa RP Due to Mutations in Exon 13 of the USH2A Gene
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Two-Year Double-masked Randomized Sham-Controlled Study to Evaluate the Efficacy Safety and Tolerability of Ultevursen in Subjects with Retinitis Pigmentosa RP Due to Mutations in Exon 13 of the USH2A Gene
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LUNA
Brief Summary:
The purpose of this Phase 2b study is to evaluate the safety and tolerability of Ultevursen administered via intravitreal injection IVT in subjects with Retinitis Pigmentosa RP due to mutations in exon 13 of the USH2A gene This is a multicenter Double-masked Randomized Sham-controlled study which will enroll 81 subjects
Detailed Description:
A total of eighty-one 81 RP participants will be enrolled in this study randomized in a 21 ratio to either Ultevursen or sham procedure respectively Subjects randomized to the active treatment group will receive therapy with Ultevursen administered via intravitreal IVT injection to the treatment eye TE on Day 1 and at Months 6 12 and 18 Subjects randomized to sham will undergo a sham procedure in the TE at the corresponding timepoints
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None