Active — Not RecruitingPhase 1/2

Fellow-eye Study (FE) of LX101 in Subjects With Inherited Retinal Dystrophy

China9 participantsStarted 2023-09-12

Plain-language 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.

Who can participate

Age range6 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Safety: Incidence of adverse events (AEs) and serious adverse events (SAEs)

Timeframe: 6 months

Trial details

NCT IDNCT06212297

SponsorInnostellar Biotherapeutics Co.,Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-06

View on ClinicalTrials.gov More Inherited Retinal Dystrophy trials