NCT07317934

Efficacy and Safety of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (STELLAR)

A Phase III, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Subretinal Injection of LX102 in Participants With Neovascular Age-Related Macular Degeneration - The STELLAR Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 332 (estimated)
• Sponsor: Innostellar Biotherapeutics Co.,Ltd · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase III, randomized, open-label, active-controlled study to evaluate the efficacy and safety of subretinal injection of LX102 in participants with neovascular age-related macular degeneration. The study will evaluate a single subretinal injection of LX102 compared to an active comparator. The primary endpoint of this study is the mean change from D0 in BCVA based on an average at weeks 40 and 48.

Conditions

• Neovascular Age-Related Macular Degeneration (nAMD)
• Wet AMD

Interventions

Type	Name	Description
GENETIC	LX102	Study eyes will receive a single subretinal injection of LX102.
BIOLOGICAL	Aflibercept	Study eyes will receive 3 monthly loading doses of aflibercetp 2mg IVT and aflibercept 2mg IVT every 8 weeks.

Timeline

• Start date: 2026-01-14
• Primary completion: 2028-03-01
• Completion: 2032-06-04
• First posted: 2026-01-05
• Last updated: 2026-03-05

Locations

31 sites across 1 country: China