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

Innostellar Biotherapeutics

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Inherited Retinal Dystrophy

Treatments: Genetic: LX101

Study type: Interventional

Funder types: Industry

Identifiers

NCT06212297

INNOSTELLAR-LX101-2

Details and patient eligibility

About

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.

Enrollment: 9 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

LX101 Subretinal Administration

Experimental group

Treatment:

Genetic: LX101