An Exploratory Clinical Study Evaluating LX111 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD)

Status: Recruiting
Location: See location...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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

• Subjects must have received a minimum of 2 injections within 6 months prior to screening and demonstrated a meaningful response to anti-VEGF therapy

• Male subjects whose partner is a fertile female or female subjects who are fertile, agree to take effective contraceptive measures from the screening period until the last follow-up.

Locations
Other Locations
China
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Time Frame
Start Date: 2025-07-02
Estimated Completion Date: 2029-12-30
Participants
Target number of participants: 10
Treatments
Experimental: LX111 intravitreal injections
Sponsors
Leads: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators: Innostellar Biotherapeutics Co.,Ltd

This content was sourced from clinicaltrials.gov