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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-14

Study Completion Date

2025-05-31

Brief Summary

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This study "A Long-Term Follow-Up Study in Subjects Who Received an Adeno-Associated Viral Vector Serotype 2 Containing the Multi-Characteristic Opsin Gene (vMCO-I) Administered Via Intravitreal Injection" is an observational study and will be conducted following Good Clinical Practice (GCP)- International Conference on Harmonization (ICH) guidelines. Eligible subjects satisfying all inclusion and none of the exclusion criteria will be enrolled. All subject who completed the parent clinical study (NSCT/CT/18/01) will undergo safety and efficacy assessments up to 5 years post study drug injection

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Detailed Description

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The observational study population comprises of individuals 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.

Enrolled subjects will undergo safety and efficacy assessments for up to 5 years from the vMCO-I administration. At the visits, subjects will have safety and efficacy evaluations. Subjects will have a final visit at 60 months post study drug administration.

Conditions

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Retinitis Pigmentosa Retinal Disease Retinal Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observation of Participants exposed to 1.2E11gc/eye of vMCO-I

This is a long-term follow-up observational study of participants who previously received 1.2E11gc/eye of vMCO-I No investigational product will be administered in this study.

Gene Therapy product:vMCO-I

Intervention Type BIOLOGICAL

Safety evaluation to monitor long term effects of previously injected vMCO-I in RP patients

Observation of Participants exposed to 0.6E11gc/eye of vMCO-I

This is a long-term follow-up observational study of participants who previously received 0.6E11gc/eye of vMCO-I No investigational product will be administered in this study.

Gene Therapy product:vMCO-I

Intervention Type BIOLOGICAL

Safety evaluation to monitor long term effects of previously injected vMCO-I in RP patients

Interventions

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Gene Therapy product:vMCO-I

Safety evaluation to monitor long term effects of previously injected vMCO-I in RP patients

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.