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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Subretinal administration of LX101 to the contralateral, previously uninjected eye
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Safety: Incidence of adverse events (AEs) and serious adverse events (SAEs)
Incidence of ocular and non-ocular AEs and SAEs following LX102 subretinal injection
Time frame: 6 months
Full-field Light Sensitivity Threshold (FST) Test
Changes in light sensitivity from baseline, assessed by FST in log cd.s/m2
Time frame: 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
Time frame: 6 months、12 months
Mobility Test
Changes in functional vision from baseline, determined by mobility test score
Time frame: 6 months、12 months
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