The goal of this study is to evaluate the safety and efficacy of LX111 treatment of DME. This study will enroll participants aged ≥ 18 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 ≥ 18;
Type I or Type II diabetes mellitus with macular thickening secondary to DME involving the center of the fovea;
CST ≥ 300 μm in the study eye at Screening;
Active proliferative diabetic retinopathy (PDR);
Presence of iris neovascularization in the study eye at Screening;
Retinal laser photocoagulation in the study eye within 3 months prior to Screening;
Prior gene therapy in the study eye;
Sequential
LX111 Injection
GeneticLX111 is an rAAV gene therapy vector carrying a coding sequence for VEGF-trap.
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 participants who received anti-VEGF supplemental injection within 52 weeks after LX111 treatment
The proportion of participants who received anti-VEGF supplemental injection within 52 weeks after LX111 treatment
Proportion of participants achieving an improvement or worsening in DR in the study eye per the ETDRS-DRSS on ultra-wide field fundus photography.
To evaluate the effect of LX111 on DR (ETDRS-DRSS) over time.
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead sponsor
Innostellar Biotherapeutics Co.,Ltd
Collaborator
