NCT06492850

Gene Therapy for RPGR Gene Mutation-associated X-linked Retinitis Pigmentosa

A Phase I/II Dose-escalation and Dose-expansion Study to Evaluate the Safety and Efficacy of FT-002 Subretinal Injection in Subjects With RPGR Gene Mutation-associated X-linked Retinitis Pigmentosa.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Frontera Therapeutics · Industry
• Sex: Male
• Age: 8 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to evaluate the safety, tolerability, and efficacy of one-time subretinal injection of FT-002 in male subjects (8-45 years of age) with RPGR (Retinitis Pigmentosa GTPase Regulator) gene mutation-associated X-linked retinitis pigmentosa, of XLRP. This study includes Phase I (dose escalation phase) and Phase II (dose expansion phase).

Conditions

• X-Linked Retinitis Pigmentosa (XLRP)

Interventions

Type	Name	Description
GENETIC	FT-002	Intraocular injection of a single dose

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-08-01
• Completion: 2026-02-01
• First posted: 2024-07-09
• Last updated: 2024-07-09

Locations

1 site across 1 country: China