Non-interventional Long Term Follow-up Study of Participants Previously Enrolled in the STARLIGHT Study

Plain-language summary

This is a non-interventional long-term follow-up study for people who previously received the gene therapy MCO-010 in the STARLIGHT study. No new treatment is given; the goal is to monitor the long-term health of those who received the earlier therapy. People who took part in the prior study and completed the required assessments may join. It is a non-phase follow-up study that is currently active but not recruiting new participants.

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

10/19/2023

Estimated completion

7/1/2027

Countries

United States

Related genes

Locations

• Miami, United States
• McAllen, United States

Eligibility criteria

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

Inclusion Criteria:

* Subjects are eligible to be included in the study only if all of the following criteria apply:

  1. Previously enrolled in study NTXMCO-004 study
  2. Able to comprehend and give informed consent.
  3. Able to comply with testing and all protocol tests.
  4. Agree to participate for the full 4-year study duration 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 the Week 48 visit for the STARLIGHT study