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
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
- Retinitis Pigmentosa
- Retinal Disease
- Retinal Degeneration
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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