Trials / Enrolling By Invitation
Enrolling By InvitationNCT05921162
A Long-Term Follow-Up Study in Subjects Who Received vMCO-I Administered Via Intravitreal Injection
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
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 11 (estimated)
- Sponsor
- Nanoscope Therapeutics Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Gene Therapy product:vMCO-I | Safety evaluation to monitor long term effects of previously injected vMCO-I in RP patients |
Timeline
- Start date
- 2023-07-14
- Primary completion
- 2025-05-01
- Completion
- 2025-05-01
- First posted
- 2023-06-27
- Last updated
- 2025-03-25
Locations
1 site across 1 country: India
Source: ClinicalTrials.gov record NCT05921162. Inclusion in this directory is not an endorsement.