Status:
ACTIVE_NOT_RECRUITING
Non-interventional Long Term Follow-up Study of Participants Previously Enrolled in the STARLIGHT Study
Lead Sponsor:
Nanoscope Therapeutics Inc.
Conditions:
Stargardt Disease
Eligibility:
All Genders
16+ years
Brief Summary
The current study is a non-interventional long-term safety follow-up of the subjects who completed STARLIGHT, in accordance with FDA guidance on recipients of human gene therapy products.
Detailed Description
This study is designed to follow subjects with Stargardt Disease (SD) previously enrolled in study NTXMCO-004 (STARLIGHT, NCT05417126). In that study, all 6 enrolled subjects received MCO-010, an ambi...
Eligibility Criteria
Inclusion
- Subjects are eligible to be included in the study only if all of the following criteria apply:
- Previously enrolled in study NTXMCO-004 study
- Able to comprehend and give informed consent.
- Able to comply with testing and all protocol tests.
- Agree to participate for the full 4-year study duration to the best of their ability and barring any unforeseen circumstances.
Exclusion
- 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
Key Trial Info
Start Date :
October 19 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06048185
Start Date
October 19 2023
End Date
July 1 2027
Last Update
March 24 2025
Active Locations (2)
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1
Nanocope Clnical Site
Miami, Florida, United States, 33136
2
Nanoscope Clinical Site
McAllen, Texas, United States, 78503