Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05921162
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-08-02
First Post:
2023-06-19
Brief Title:
A Long-Term Follow-Up Study in Subjects Who Received vMCO-I Administered Via Intravitreal Injection
Sponsor:
Nanoscope Therapeutics Inc
Organization:
Nanoscope Therapeutics Inc
Study Overview
Official Title:
A Long-Term Follow-Up Study in Subjects Who Received an Adeno-Associated Viral Vector Serotype 2 Containing the Multi-Characteristic Opsin Gene vMCO-I Administered Via Intravitreal Injection
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-07
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:
EXTEND
Brief Summary:
This study A Long-Term Follow-Up Study in Subjects Who Received an Adeno-Associated Viral Vector Serotype 2 Containing the Multi-Characteristic Opsin Gene vMCO-I Administered Via Intravitreal Injection is an observational study and will be conducted following Good Clinical Practice GCP- International Conference on Harmonization ICH guidelines Eligible subjects satisfying all inclusion and none of the exclusion criteria will be enrolled All subject who completed the parent clinical study NSCTCT1801 will undergo safety and efficacy assessments up to 5 years post study drug injection
Detailed Description:
The observational study population comprises of individuals who received an Adeno-Associated Viral Vector Serotype 2 Containing the Multi-Characteristic Opsin Gene vMCO-I Administered Via Intravitreal Injection in a parent study
Enrolled subjects will undergo safety and efficacy assessments for up to 5 years from the vMCO-I administration At the visits subjects will have safety and efficacy evaluations Subjects will have a final visit at 60 months post study drug administration
Enrolled subjects will undergo safety and efficacy assessments for up to 5 years from the vMCO-I administration At the visits subjects will have safety and efficacy evaluations Subjects will have a final visit at 60 months post study drug administration
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