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

Launched by NANOSCOPE THERAPEUTICS INC. · Sep 15, 2023

Keywords

ClinConnect Summary

This clinical trial is a long-term follow-up study for people who previously participated in the STARLIGHT study, which focused on Stargardt disease, a condition that affects vision. The goal of this study is to monitor the safety of those who received gene therapy as part of their earlier treatment. This means that the researchers want to see how these patients are doing over time and ensure there are no unexpected side effects from the therapy.

To be eligible for this study, participants must have previously taken part in the STARLIGHT study, be able to understand and give their consent, and agree to follow the study's requirements for four years. There are no additional exclusions, so if someone meets these criteria, they can be part of the follow-up. Participants can expect to attend regular check-ups to help the researchers gather important information about their health and any changes in their vision. Overall, this study is a chance for those previously involved in STARLIGHT to continue contributing to valuable research about their condition.

Gender

ALL

Eligibility criteria

• 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