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

NCT06048185 · tracked via the Priya Life Science USA tracker

Sponsor

Nanoscope Therapeutics Inc.

Phase

Observational

Started

2023-10-19

Last updated

2025-03-24

Condition(s) studied

Stargardt Disease

Investigational drug(s) / intervention(s)

Gene Therapy Product-MCO-010

Gene Therapy Product-MCO-010: The MCO-010 is an adeno-associated virus serotype 2-based vector carried multi-characteristic opsin (MCO) gene expression cassette

Study 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.

Eligibility

Sex

ALL

Min age

16 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Assessment of the long-term safety profile of a single intravitreal injection of MCO-010 — 204 weeks
Assessment of incidences, nature, and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs); intraocular inflammation graded through ocular exam; clinical examination, and intraocular pressure.

Trial sites (2)

Facility	City	Region	Status
Nanocope Clnical Site	Miami	Florida
Nanoscope Clinical Site	McAllen	Texas

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06048185 on ClinicalTrials.gov ↗ ← All trials in the USA