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Clinical Trials in China / NCT06212297
Active, not recruiting Phase 1/2

Fellow-eye Study (FE) of LX101 in Subjects With Inherited Retinal Dystrophy

NCT06212297 · tracked via the Priya Life Science China tracker
Sponsor
Innostellar Biotherapeutics Co.,Ltd
Phase
Phase 1/2
Started
2023-09-12
Last updated
2025-06-29

Condition(s) studied

Inherited Retinal Dystrophy

Investigational drug(s) / intervention(s)

LX101

LX101: Subretinal administration of LX101 to the contralateral, previously uninjected eye

Study summary

Up to nine subjects who have participated in the earlier LX101 clinical study, and who meet all study eligibility criteria, will receive LX101 administration in the previously uninjected, contralateral eye to evaluate the safety of bilateral, sequential subretinal administration of LX101.

Eligibility

Sex
ALL
Min age
6 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Prior subretinal administration of LX101 (unilateral) ≥ 6 years old Signed written informed consent Exclusion Criteria: Prior gene therapy except LX101 Active intraocular or periocular infections Lacking of sufficient surviving retinal cells Prior ocular surgery within six months Retinoid like compounds or precursors were taken within three months Complicating systemic diseases Clinically significant abnormal baseline laboratory values Using of any retinal toxic compounds

Primary outcome measure(s)

  • Safety: Incidence of adverse events (AEs) and serious adverse events (SAEs) — 6 months
    Incidence of ocular and non-ocular AEs and SAEs following LX102 subretinal injection

Trial sites (1)

FacilityCityRegionStatus
Shanghai General Hospital Shanghai Shanghai Municipality

More Innostellar Biotherapeutics Co.,Ltd trials in China

Safety and Tolerability of LX101 for Inherited Retinal Dystrophy Associated With RPE65 Mutations Active, not recruiting
LX102 in Patients With Neovascular Age-Related Macular Degeneration (nAMD) Active, not recruiting
Safety and Efficacy of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (VENUS) Active, not recruiting
Efficacy and Safety of LX101 for Inherited Retinal Dystrophy Associated With RPE65 Mutations Active, not recruiting
Efficacy and Safety of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (STELLAR) Recruiting

Other trials for the same condition

Safety and Efficacy Study of PUMCH-E111 Injection in Subjects With RLBP1 Related Inherited Retinal Dystrophy Recruiting
A Multicenter, Randomized, Double-Blind, Controlled Clinical Study of Minocycline for the Treatment of Retinitis Pigmentosa Starting soon
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 NCT06212297 on ClinicalTrials.gov ↗ ← All trials in China