An observational study in Stargardt Disease, sponsored by Nanoscope Therapeutics Inc.. Active, not recruiting at 2 sites in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-03-24.
Sponsored by Nanoscope Therapeutics Inc. · Observational
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.
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 ambient light-activated, Multi-Characteristic Opsin (MCO) transgene in an adeno-associated virus serotype 2 (AAV2) vector via intravitreal injection (IVT). MCO-010 has the potential to restore vision irrespective of the underlying gene mutation, and because it is directed at bipolar retinal cells, intact photoreceptors are not required. Further details on MCO-010 and the underlying disease under investigation are included in the protocol for STARLIGHT and are not repeated herein
67 studies on the registry are indexed under Stargardt Disease; 26 are open to participants now.
This study's planned enrollment of 6 is below the median of 50 across 23 observational studies indexed under Stargardt Disease.
Browse Stargardt Disease studies →Nanoscope Therapeutics Inc. is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population eligible to participate will comprise of the 6 subjects previously enrolled in STARLIGHT.
Subjects are eligible to be included in the study only if all of the following criteria apply:
Exclusion Criteria:
The MCO-010 is an adeno-associated virus serotype 2-based vector carried multi-characteristic opsin (MCO) gene expression cassette
Assessment of the long-term safety profile of a single intravitreal injection of MCO-010
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.
Time frame: 204 weeks
Evaluation of the long-term effects on visual acuity of a single intravitreal injection of MCO-010; 1.2E11 gc/eye
Change from baseline in BCVA over time in the study eye and fellow eye
Time frame: 204 weeks
Exploration of the long-term impact of MCO-010 on retinal anatomy
Assessment of fundus photography and optical coherence tomography (OCT) outcomes over time
Time frame: 204 weeks
Assessment of the long-term durability of MCO-010 induced on gene reporter expression
Change from baseline of fundus fluorescence intensity of reporter (mCherry) over time in the study eye and fellow eye
Time frame: 204 weeks
Plan to share: Yes — The results of the clinical trial will be made available when the study is completed. The results will be published on this site and be available to conference presentations and publications.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Nanoscope Therapeutics Inc.