Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460844
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-10
Brief Title:
Study to Evaluate Safety of RTx-015 Injection in Retinitis Pigmentosa Patients ENVISION
Sponsor:
Ray Therapeutics Inc
Organization:
Ray Therapeutics Inc
Study Overview
Official Title:
Phase 1 Open-Label Dose-Escalation Study to Evaluate Safety of a Single Intravitreal Injection of RTx-015 in Patients With Retinitis Pigmentosa ENVISION
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:
None
Brief Summary:
A Phase 1 open-label non-randomized dose-escalation study where approximately 9 eligible patients with retinitis pigmentosa will be enrolled sequentially in up to 3 dose cohorts of RTx-015 Enrolled patients will receive a single unilateral intravitreal injection of RTx-015 in the study eye at Visit 3 Day 0 and be followed for a total of 12 months
Detailed Description:
This Phase 1 open-label non-randomized multicenter clinical trial is to evaluate the safety and preliminary efficacy of a single uniocular intravitreal injection of an investigational optogenetic gene therapy RTx-015 in patients with retinitis pigmentosa Up to 3 dose cohorts are planned and each cohort will consist initially of 3 patients Eligible patients will be assigned to a dose cohort by sequential enrollment
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?:
None
Is an FDA AA801 Violation?:
None