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
Verified date | January 2024 |
Source | Innostellar Biotherapeutics Co.,Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Shanghai General Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Innostellar Biotherapeutics Co.,Ltd |
China,
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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