NCT06289452

Safety and Efficacy Study of IVB102 Injection in Subjects With X-linked Retinoschisis

An Open-label, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IVB102 Injection in Subjects With X-linked Retinoschisis (XLRS)

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: InnoVec Biotherapeutics Inc. · Industry
• Sex: Male
• Age: 8 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of IVB102 injection in subjects with XLRS.

Detailed description

This is a open label, dose escalation, single-center study. One eye of each participant will receive a single IVB102 injection by intravitreal injection. Participants will be followed for 52 weeks after which they will continue to be followed for up to 5 years after enrollment.

Conditions

• Retinoschisis
• Retinal Disease
• Retinal Degeneration
• Eye Diseases

Interventions

Type	Name	Description
GENETIC	IVB102 Injection	Gene transfer by intravitreal injection of the RS1 AAV vector
GENETIC	IVB102 Injection	Gene transfer by intravitreal injection of the RS1 AAV vector
GENETIC	IVB102 Injection	Gene transfer by intravitreal injection of the RS1 AAV vector

Timeline

• Start date: 2024-03-08
• Primary completion: 2025-12-31
• Completion: 2029-12-31
• First posted: 2024-03-01
• Last updated: 2025-04-30

Locations

1 site across 1 country: China