The goal of this study is to evaluate the safety and efficacy of LX102-C01 treatment of nAMD. This study will enroll subjects aged ≥ 50 years old to receive a single unilateral intravitreal (IVT) injection of LX102-C01 to evaluate its safety and efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Qualified subjects will receive a single unilateral intravitreal injection of LX102-C01 at Day 0 in the trial.
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Incidence of adverse events (AEs)
Incidence of adverse events (AEs) within 52 weeks of LX102-C01 intravitreal injection at different doses
Time frame: 52 weeks
Incidence of serious adverse events (SAEs)
Incidence of serious adverse events (SAEs) within 52 weeks of LX102-C01 intravitreal injection at different doses
Time frame: 52 weeks
Mean change in BCVA from Baseline
BCVA measured by ETDRS
Time frame: 24 weeks, 52weeks
Mean change in Central Subfield Thickness (CST) from Baseline
To evaluate the effect of LX102-C01 on CST
Time frame: 24 weeks, 52 weeks
Mean number of anti-VEGF injections over time
Mean number of anti-VEGF injections over time
Time frame: 52 weeks
Change of quality of life scores (VFQ-25) from Baseline
Changes of VFQ-25 questionaire from Baseline to 52 weeks
Time frame: 52 weeks
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