Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04919473
Status:
COMPLETED
Last Update Posted:
2021-06-09
First Post:
2021-05-25
Brief Title:
Dose-Escalation Study to Evaluate the Safety and Tolerability of Intravitreal vMCO-I in Patients With Advanced Retinitis Pigmentosa
Sponsor:
Nanoscope Therapeutics Inc
Organization:
Nanoscope Therapeutics Inc
Study Overview
Official Title:
A Phase IIIa Open Label Dose-Escalation Study to Evaluate the Safety and Tolerability of Intravitreal vMCO-I in Patients With Advanced Retinitis Pigmentosa
Status:
COMPLETED
Status Verified Date:
2021-06
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 purpose of the study is to evaluate the safety and tolerability of a single intravitreal injection of virally-carried Multi-Characteristic Opsin I vMCO-I
Detailed Description:
This open label dose-escalation study evaluated 2 dose levels in up to 11 subjects of retinitis pigmentosa 3 in low dose and 8 in high dose per dose with active vMCO-010 Subjects with confirmed diagnosis of Advanced Retinitis Pigmentosa RP based on clinical examination and dilated fundus examination were considered for participation in this study The primary endpoint for this study is safety and tolerability of vMCO-I at 16 weeks All subjects were assessed for 52 weeks following treatment with vMCO-I
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