A Long-Term Follow-Up Study in Subjects Who Received vMCO-I Administered Via Intravitreal Injection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gene Therapy product:vMCO-I.
- Who it may be relevant to
- Registry conditions: Retinitis Pigmentosa, Retinal Disease, Retinal Degeneration. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
Detailed description
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.
Interventions
- Biological Gene Therapy product:vMCO-I
Safety evaluation to monitor long term effects of previously injected vMCO-I in RP patients
Primary outcome measures
- Assessment of the long-term safety profile of a single intravitreal injection of vMCO-I [Time frame: 20 Months]
- Evaluation of the long-term efficacy of a single intravitreal injection of Multi-Characteristic Opsin (vMCO-I) [Time frame: 20 Months]
Secondary outcome measures (2)
- Assessment of the effect of vMCO-I on functional vision outcomes [Time frame: 20 Months]
- Assessment of the durability of vMCO-I induced gene reporter expression [Time frame: 20 Months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
India · 1 center
- JPM Rotary Club of Cuttack Eye Hospital and Research Institute — Cuttack
Identifiers
NCT: NCT05921162 · NTXMCO-005