Clinical trial NCT05921162: A Long-Term Follow-Up Study in Subjects Who Received vMCO-I Administered Via Intravitreal 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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Retinitis Pigmentosa
Retinal Disease
Retinal Degeneration
Keywords: Optogenetics
Gene Therapy
AAV Vectors
Multicharacteristic Opsin (MCO)-I
Lead sponsor: Nanoscope Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It is expected that a total of 11 study subjects from NSCT/CT/18/01 study will be enrolled. Subjects who meet all the inclusion criteria and for whom none of the exclusion criteria apply will be eligible for enrollment.

Brief 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

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.

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.

Primary outcomes:
measure: Assessment of the long-term safety profile of a single intravitreal injection of vMCO-I
timeFrame: 20 Months
measure: Evaluation of the long-term efficacy of a single intravitreal injection of Multi-Characteristic Opsin (vMCO-I)
timeFrame: 20 Months
Secondary outcomes:
measure: Assessment of the effect of vMCO-I on functional vision outcomes
timeFrame: 20 Months
measure: Assessment of the durability of vMCO-I induced gene reporter expression
timeFrame: 20 Months
Other outcomes:
Locations:
city: Cuttack
country: India
facility: JPM Rotary Club of Cuttack Eye Hospital and Research Institute
state: Odisha
Study officials:
affiliation: Nanoscope Therapeutics Inc.
name: Samarendra Mohanty
role: STUDY_DIRECTOR
References: