Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06162585
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-12-14
First Post:
2023-11-30
Brief Title:
Non-Interventional Long Term Follow-up Study of Participants Previously Enrolled in the RESTORE Study
Sponsor:
Nanoscope Therapeutics Inc
Organization:
Nanoscope Therapeutics Inc
Study Overview
Official Title:
Long Term Follow-up for Subjects Who Previously Participated in the NTXMCO-002 RESTORE Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-12
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:
REMAIN
Brief Summary:
This study will be conducted following Good Clinical Practice GCP and International Conference on Harmonization ICH guidelines Eligible subjects will be consented to return for scheduled study visits for this study following their completion in study NTXMCO-002 RESTORE They will not receive a second treatment with MCO-010 or a repeated sham injection in this study
Detailed Description:
This study is designed to follow subjects with Retinitis Pigmentosa RP previously enrolled in study NTXMCO-002 RESTORE NCT04945772 In that study 18 of 27 enrolled subjects received MCO-010 an ambient light-activated Multi-Characteristic Opsin MCO transgene in an adeno-associated virus serotype 2 AAV2 vector via intravitreal injection IVT and 9 of 27 received a sham injection Those who received the sham injection will not be continued in the long-term follow-up study for drug safety MCO-010 has the potential to restore vision irrespective of the underlying gene mutation and because it is directed at bipolar retinal cells intact photoreceptors are not required Further details on MCO-010 and the underlying disease under investigation are included in the protocol for RESTORE and are not repeated herein
The current study is a non-interventional long-term safety follow-up of the subjects who completed RESTORE in accordance with FDA guidance on recipients of human gene therapy products
The current study is a non-interventional long-term safety follow-up of the subjects who completed RESTORE in accordance with FDA guidance on recipients of human gene therapy products
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