Status:
ACTIVE_NOT_RECRUITING
Fellow-eye Study (FE) of LX101 in Subjects With Inherited Retinal Dystrophy
Lead Sponsor:
Innostellar Biotherapeutics Co.,Ltd
Conditions:
Inherited Retinal Dystrophy
Eligibility:
All Genders
6+ years
Phase:
PHASE1
PHASE2
Brief 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, contralatera...
Eligibility Criteria
Inclusion
- Prior subretinal administration of LX101 (unilateral)
- ≥ 6 years old Signed written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
September 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06212297
Start Date
September 12 2023
End Date
March 1 2029
Last Update
June 29 2025
Active Locations (1)
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1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080