Clinical trial

Long Term Follow-up for Participants Who Previously Received a Single Intravitreal Injection of MCO-010 Optogenetic Therapy in the STARLIGHT Study

Name

NTXLTFU-007

Description

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.

Trial arms

Trial start

2023-10-19

Estimated PCD

2027-05-01

Trial end

2027-07-01

Treatment

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

Size

Primary endpoint

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

204 weeks

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'enrollmentInfo': {'count': 6, 'type': 'ESTIMATED'}}

Updated at

2023-11-09

1 organization

1 product

1 indication

Organization

Nanoscope Therapeutics

Product

MCO-010

Indication

Stargardt Disease