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.
Willing to sign the informed consent, and willing to attend follow-up visits.
Age ≥ 50
Diagnosis of active CNV secondary to neovascular AMD
BCVA ETDRS letters between 5 and 63
CNV or macular edema in the study eye secondary to diseases other than nAMD
Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement
Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months
Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg
Single group
LX111 Injection
GeneticQualified subjects will receive a single unilateral intravitreal injection of LX111 at Day 0.
Adverse 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.
Dose Limiting Toxicity
The incidence of DLT in each dose group.
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.
Mean changes in Central Subfield Thickness (CST) from Baseline
The mean changes of CST at different timepoints after LX111 treatment compared with baseline.
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
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead sponsor
Innostellar Biotherapeutics Co.,Ltd
Collaborator
