Non-Interventional Long Term Follow-up Study of Participants Previously Enrolled in the RESTORE Study

Plain-language summary

This non-interventional long-term follow-up study monitors participants who previously completed study NTXMCO-002 (RESTORE) through scheduled study visits. Participants do not receive a second treatment with the gene therapy product MCO-010 or a repeated sham injection in this study. It is conducted following Good Clinical Practice (GCP) and ICH guidelines, and participants must be able to give informed consent, comply with all protocol testing, and agree to take part for the full 3-year follow-up period barring unforeseen circumstances.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Active, not recruiting

Sponsor

Nanoscope Therapeutics Inc.

Intervention

Gene Therapy product-MCO-010

Start date

12/8/2023

Estimated completion

9/1/2027

Countries

United States, Puerto Rico

Related genes

Locations

• Beverly Hills, United States
• Pensacola, United States
• Fargo, United States
• Houston, United States
• McAllen, United States
• Arecibo, Puerto Rico

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Previously enrolled in study NTXMCO-002 (RESTORE)
* Able to comprehend and give informed consent.
* Able to comply with testing and all protocol tests.
* Agree to participate for the full 3-year duration of follow-up to the best of their ability and barring any unforeseen circumstances.

Exclusion Criteria:

* Not applicable. Subjects will be included in this study and will be consented after completion of all assessments at their final RESTORE study visit