NCT06022744

An Exploratory Clinical Trial Evaluating LX109 Gene Therapy in Patients With nAMD

An Exploratory Clinical Trial Evaluating LX109 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability of intravitreal injection of LX109 in patients with nAMD.

Detailed description

In this study, 9 to 12 participants were enrolled in an open monocular, single dose escalation study design. Two dose groups were set up: low dose group (7×109 VG/ eye, 0.05ml) and high dose group (3.5×1010 VG/ eye, 0.05ml). Among them, 3 to 6 subjects were enrolled in low-dose group and 6 subjects were enrolled in high-dose group.

Conditions

• To Evaluate the Safety and Tolerability of Intravitreal Injection of LX109 in Patients With nAMD

Interventions

Type	Name	Description
DRUG	LX109	LX109 gene injection Specification: 0.2ml/bottle, 1.4×1012VG/ml Administration route: intravitreal injection, injection volume 0.05ml/eye

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-09-30
• Completion: 2027-09-30
• First posted: 2023-09-05
• Last updated: 2023-09-05