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

NCT05921162 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 11

Last updated 2025-03-25

No results posted yet for this study

Summary

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

Conditions

Interventions

BIOLOGICAL

Gene Therapy product:vMCO-I

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

Sponsors & Collaborators

  • Nanoscope Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Samarendra Mohanty · Nanoscope Therapeutics Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-14
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • India

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05921162 on ClinicalTrials.gov