The goal of this study is to evaluate the safety and efficacy of LX111 treatment of nAMD. This study will enroll subjects aged ≥ 50 vears old to receive a single unilateral intravitreal (lVT) injection of LX111 to evaluate its safety and efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Qualified subjects will receive a single unilateral intravitreal injection of LX111 at Day 0.
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
RECRUITINGAdverse events and serious adverse events in the eyes and throughout the body within 364 days after LX111 treatment
Incidence of adverse events and serious adverse events within 52 weeks of LX111 intravitreal injection in each dose group.
Time frame: 52 weeks
Dose Limiting Toxicity
The incidence of DLT in each dose group.
Time frame: 4 weeks
Mean changes in BCVA from Baseline
The mean changes of BCVA scores on the ETDRS chart at different timepoints after LX111 treatment compared with baseline.
Time frame: 12 weeks, 36 weeks, 52 weeks
Mean changes in Central Subfield Thickness (CST) from Baseline
The mean changes of CST at different timepoints after LX111 treatment compared with baseline.
Time frame: 12 weeks, 36 weeks, 52 weeks
The percentage of subjects who received anti-VEGF supplemental injection within 52 weeks after LX111 treatment
The proportion of subjects who received anti-VEGF supplemental injection within 52 weeks after LX111 treatment
Time frame: 52 weeks
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