Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200080, China
Location status: Recruiting
NCT Number: NCT07053358
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.
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Early Phase 1
Shanghai, 200080, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Qualified subjects will receive a single unilateral intravitreal injection of LX111 at Day 0.
Time frame: 52 weeks
Incidence of adverse events and serious adverse events within 52 weeks of LX111 intravitreal injection in each dose group.
Time frame: 4 weeks
The incidence of DLT in each dose group.
Time frame: 12 weeks, 36 weeks, 52 weeks
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
The mean changes of CST at different timepoints after LX111 treatment compared with baseline.
Time frame: 52 weeks
The proportion of subjects who received anti-VEGF supplemental injection within 52 weeks after LX111 treatment
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Other
An Exploratory Clinical Study Evaluating LX111 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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