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

Running, not enrolling

Conditions studied: Stargardt Disease

In brief

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.

Key facts

Study ID

NCT06048185

Run by

Nanoscope Therapeutics Inc.

People needed

6

Starts

2023-10-19

Expected to finish

2027-07-01

Last updated by the study team

2025-03-24

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Nanocope Clnical Site — Miami, Florida, United States
• Nanoscope Clinical Site — McAllen, Texas, United States

Full record on ClinicalTrials.gov

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