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Gene Therapy for RPGR Gene Mutation-associated X-linked Retinitis Pigmentosa
Sponsor: Frontera Therapeutics
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).
Official title: 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.
Key Details
Gender
MALE
Age Range
8 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2024-04-01
Completion Date
2026-02-01
Last Updated
2024-07-09
Healthy Volunteers
No
Conditions
Interventions
FT-002
Intraocular injection of a single dose
Locations (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China