Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574997
Status:
AVAILABLE
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Expanded Access Program for RP in Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Expanded Access Program for Retinitis Pigmentosa in Adults Aged 18 Years and Older
Status:
AVAILABLE
Status Verified Date:
2024-08
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:
None
Brief Summary:
This intermediate-size patient population expanded access program is to provide access to investigational product OCU400 for up to 75 patients with Retinitis Pigmentosa RP outside of the ongoing clinical trial Phase 3 program for patients who do not have access to alternative Food and Drug Administration FDA-approved products for treatment of the disease
Detailed Description:
This expanded access protocol provides access to OCU400 for a subset of patients Subjects will undergo specific ocular testing included in the study Subjects will follow-up with physical examination review of concomitant medication blood work and ocular examinations for up to 52 weeks about 12 months post dosing
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: