drugset / Trial / NCT07317934

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

NCT07317934

Phase 3 Recruiting 332 enrolled Innostellar Biotherapeutics Co.,Ltd
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-01-14
Primary completion
2028-03
Completion
2032-06-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aflibercept Protein / enzyme biologic 2 mg Intravitreal
Subject LX102 Gene therapy (AAV / viral vector) Other