LX101: Subretinal administration of LX101 to the contralateral, previously uninjected eye
Study 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.
Eligibility
Sex
ALL
Min age
6 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Safety: Incidence of adverse events (AEs) and serious adverse events (SAEs) — 6 months Incidence of ocular and non-ocular AEs and SAEs following LX102 subretinal injection
Trial sites (1)
Facility
City
Region
Status
Shanghai General Hospital
Shanghai
Shanghai Municipality
More Innostellar Biotherapeutics Co.,Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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