A Long-Term Follow-Up Study in Subjects Who Received vMCO-I Administered Via Intravitreal Injection

Plain-language summary

This observational long-term follow-up study monitors people who received vMCO-I by intravitreal injection in a parent study (NSCT/CT/18/01). vMCO-I is a gene therapy product based on an adeno-associated viral vector serotype 2 carrying the Multi-Characteristic Opsin gene. Participants undergo safety and efficacy assessments for up to 5 years after the study drug injection, and the study is conducted under Good Clinical Practice (GCP) and ICH guidelines.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Enrolling by invitation

Sponsor

Nanoscope Therapeutics Inc.

Intervention

Gene Therapy product:vMCO-I

Start date

7/14/2023

Estimated completion

5/1/2025

Countries

India

Related genes

Locations

• Cuttack, India

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* The subject population includes subjects who received an Adeno-Associated Viral Vector Serotype 2 Containing the Multi-Characteristic Opsin Gene (vMCO-I), administered via intravitreal injection in a parent study.

Exclusion Criteria:

* Subjects who will not consent for study.