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

Inherited Retinal Dystrophy Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06212297
• Other study ID #: INNOSTELLAR-LX101-2
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 12, 2023
• Est. completion date: March 2029

Study information

• Verified date: January 2024
• Source: Innostellar Biotherapeutics Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: March 2029
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inherited Retinal Dystrophy
• Retinal Dystrophies

Intervention

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

Locations

Country	Name	City	State
China	Shanghai General Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Innostellar Biotherapeutics Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events (AEs) and serious adverse events (SAEs)	Incidence of ocular and non-ocular AEs and SAEs following LX102 subretinal injection	6 months
Secondary	Full-field Light Sensitivity Threshold (FST) Test	Changes in light sensitivity from baseline, assessed by FST in log cd.s/m2	6 months?12 months
Secondary	Visual Acuity	Changes in visual acuity from baseline, based on the ability to read letters using the Early Treatment Diabetic Retionpathy Study (ETDRS) chart	6 months?12 months
Secondary	Mobility Test	Changes in functional vision from baseline, determined by mobility test score	6 months?12 months