🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06196827
Active, not recruiting Phase 1

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

NCT06196827 · tracked via the Priya Life Science China tracker
Sponsor
Innostellar Biotherapeutics Co.,Ltd
Phase
Phase 1
Started
2022-07-02
Last updated
2026-03-06

Condition(s) studied

Inherited Retinal Dystrophy Associated With RPE65 Mutations

Investigational drug(s) / intervention(s)

LX101

LX101: Subretinal Administration

Study summary

The purpose of the study is to evaluate the safety, tolerability and efficacy of LX101 in subjects with biallelic RPE65 mutation-associated inherited retinal dystrophy.

Eligibility

Sex
ALL
Min age
6 Years
Max age
Healthy volunteers
No
Inclusion Criteria: Subject and/or their guardian signing a written informed consent. Diagnosed with biallelic RPE65 mutation-associated inherited retinal dystrophy. Subjects are 6 years of age or older. Visual acuity of ≤ 20/63 or visual field less than 20 degrees in the eye to be injected. Exclusion Criteria: Prior gene therapy for IRD and other hereditary eye diseases. Pre-existing eye conditions that would interfere with interpretation of study endpoints. Active intraocular or periocular infections in the study eye. Lacking of sufficient surviving retinal cells. Prior ocular surgery within six months. Complicating systemic diseases or clinically significant abnormal baseline laboratory values. Pre-existing systemic diseases that should not discontinue the use of any retinal toxic compounds.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Beijing Tongren Hospital, Capital Medical University Beijing China
Shanghai General Hospital Shanghai China

More Innostellar Biotherapeutics Co.,Ltd trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06196827 on ClinicalTrials.gov ↗ ← All trials in China