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NCT Number: NCT06212297

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Inherited Retinal Dystrophy

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LX101

Genetic

Subretinal administration of LX101 to the contralateral, previously uninjected eye

Primary outcomes

  1. Safety: Incidence of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: 6 months

    Incidence of ocular and non-ocular AEs and SAEs following LX102 subretinal injection

Secondary outcomes

  1. Full-field Light Sensitivity Threshold (FST) Test

    Time frame: 6 months、12 months

    Changes in light sensitivity from baseline, assessed by FST in log cd.s/m2

  2. Visual Acuity

    Time frame: 6 months、12 months

    Changes in visual acuity from baseline, based on the ability to read letters using the Early Treatment Diabetic Retionpathy Study (ETDRS) chart

  3. Mobility Test

    Time frame: 6 months、12 months

    Changes in functional vision from baseline, determined by mobility test score

Sponsors and collaborators

Lead sponsor

Innostellar Biotherapeutics Co.,Ltd

Industry

Registry information

Official study title

A Clinical Trial to Evaluate the Safety and Efficacy of Subretinal Re-Administration of LX101 to the Contralateral Eye in Subjects With Biallelic RPE65 Mutation-associated Inherited Retinal Dystrophy

Important dates

Study start
2023
Primary completion
2025
Study completion
2029
First posted
Jan 18, 2024
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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