Active — Not RecruitingNot Applicable

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

United States6 participantsStarted 2023-10-19

Plain-language 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.

Who can participate

Age range16 Years

SexALL

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Inclusion criteria

✓. 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.

What they're measuring

Assessment of the long-term safety profile of a single intravitreal injection of MCO-010

Timeframe: 204 weeks

Trial details

NCT IDNCT06048185

SponsorNanoscope Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-05

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