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A Long-Term Follow-Up Study in Subjects Who Received vMCO-I Administered Via Intravitreal Injection
Sponsor: Nanoscope Therapeutics Inc.
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
11
Start Date
2023-07-14
Completion Date
2025-05
Last Updated
2025-03-25
Healthy Volunteers
No
Interventions
Gene Therapy product:vMCO-I
Safety evaluation to monitor long term effects of previously injected vMCO-I in RP patients
Locations (1)
JPM Rotary Club of Cuttack Eye Hospital and Research Institute
Cuttack, Odisha, India