drugset / Trial / NCT07054632

Efficacy and Safety of LX101 for Inherited Retinal Dystrophy Associated With RPE65 Mutations

NCT07054632 ↗

Phase 3 Active not recruiting 30 enrolled Innostellar Biotherapeutics Co.,Ltd
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to evaluate the efficacy and safety of LX101 in subjects with biallelic RPE65 mutation-associated inherited retinal dystrophy. This is an open-label, multicenter, randomized controlled Phase III clinical trial. Subjects were randomly assigned in a 1:1 ratio to either the intervention group or the control group. Subjects in the intervention group received subretinal injection of LX101, while those in the control group received no treatment.

Timeline

Start
2023-09-13
Primary completion
2025-08-13
Completion
2029-08

Drugs

EvaluationDrugModalityDoseRoute
Subject LX101 Gene therapy (AAV / viral vector) — Other