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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LX101 Subretinal Administration | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LX101 | Genetic | Subretinal administration of LX101 to the contralateral, previously uninjected eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Visual Acuity | Changes in visual acuity from baseline, based on the ability to read letters using the Early Treatment Diabetic Retionpathy Study (ETDRS) chart |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Shanghai | Shanghai Municipality | 200080 | China |
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| 6 months、12 months |
| Mobility Test | Changes in functional vision from baseline, determined by mobility test score | 6 months、12 months |