The goal of this study is to evaluate the overall safety and efficacy of LX102 gene therapy for nAMD.
In this Phase 2, multi-center, randomized controlled study, subjects will be randomized to receive one of the two dose levels of LX102 (n=20 for each dose level), or aflibercept (n=10). Safety, tolerability, and efficacy will be evaluated for a period of approximately 1 year from baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
LX102: AAV-based gene therapy comprised of codon-optimized sequence encoding VEGF-trap
Commercially available Active Comparator
Anhui Provincial Hospital
Hefei, Anhui, China
Zhejiang University Eye Hospital
Hangzhou, Zhejiang, China
Peking Union Medical College Hospital
Beijing, China
West China Hospital of Sichuan University
Mean change from baseline in Best Corrected Visual Acuity (BCVA)
BCVA measured by ETDRS
Time frame: 36 weeks
Mean change from baseline in Best Corrected Visual Acuity (BCVA)
BCVA measured by ETDRS
Time frame: 52 weeks
Mean change in Central Subfield Thickness (CST) from Baseline
CST measured by spectral domain optical coherence tomography (SD-OCT)
Time frame: 36 weeks, 52 weeks
Durability of LX102 treatment
Mean time from LX102 administration to anti-VEGF rescue injection for the first time, percentage of participants requiring anti-VEGF rescue injection, and mean number of anti-VEGF rescue injections through 52 weeks following LX102 administration.
Time frame: 52 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: 36 weeks, 52 weeks
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Chengdu, China
Guangzhou Aier Eye Hospital
Guangzhou, China
Zhongshan Ophthalmic Center of Sun Yat-Sen University
Guangzhou, China
Shanghai Eye and ENT Hospital
Shanghai, China
Shanghai General Hospital
Shanghai, China
Shanxi Eye Hospital
Taiyuan, China
Tianjin Medical University Eye Hospital
Tianjin, China
...and 1 more locations