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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06212297
Other study ID # INNOSTELLAR-LX101-2
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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