The goal of this study is to evaluate the safety and efficacy of LX102 gene therapy for nAMD.
This study will enroll subjects aged ≥ 50 years old to receive a single unilateral subretinal injection of LX102 to evaluate its safety and efficacy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
LX102: AAV-based gene therapy comprised of codon-optimized sequence encoding VEGF-trap
Anhui Provincial Hospital
Hefei, Anhui, China
Zhejiang University Eye Hospital
Hangzhou, Zhejiang, China
Shanghai General Hospital
Shanghai, China
Incidence of dose-limiting toxicity (DLT)
Incidence of dose-limiting toxicity (DLT) following LX102 subretinal injection at different doses
Time frame: 4 weeks
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Incidence of ocular and systemic adverse events (AEs) and serious adverse events (SAEs) following LX102 subretinal injection
Time frame: 52 weeks
Mean change in BCVA from Baseline
BCVA measured by ETDRS
Time frame: 12 weeks, 36 weeks 52 weeks
Mean change in Central Subfield Thickness (CST) from Baseline
CST measured by spectral domain optical coherence tomography (SD-OCT)
Time frame: 12 weeks, 36 weeks 52 weeks
Mean time from LX102 administration to anti-VEGF rescue injection for the first time
Time frame: 52 weeks
Percentage of participants requiring anti-VEGF rescue injection
Time frame: 52 weeks
Mean number of anti-VEGF rescue injections
Time frame: 52 weeks
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