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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Intraocular injection of a single dose
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGTo evaluate the safety and tolerance of FT-002
Incidence and severity of AEs
Time frame: from FT-002 administration through up to 1 years
To evaluate the efficacy of FT-002
Changes in visual sensitivity /FST/BCVAfrom baseline
Time frame: from FT-002 administration through up to 1 years
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