An Early Phase 1 interventional study of LX111 Injection in Diabetic Macular Edema (DME), sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Early Phase 1, Interventional, and Treatment
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.
This trial is a prospective, multicenter, dose-ranging trial to evaluate the safety and efficacy of LX111 in participants with DME. The trial will be conducted in two parts: Dose Confirmation and Dose Expansion.
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 173 studies on the registry; 105 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Qualified participants will receive a single unilateral intravitreal injection of LX111 at Day 0.
Genetic: LX111 Injection
Qualified participants will receive a single unilateral intravitreal injection of LX111 at Day 0.
Genetic: LX111 Injection
Qualified participants will receive a single unilateral intravitreal injection of LX111 at Day 0.
Genetic: LX111 Injection
LX111 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.
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 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
Time frame: 52 weeks
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.
Time frame: 52 weeks
Plan to share: No
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine