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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-12

Study Completion Date

2029-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Inherited Retinal Dystrophy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LX101 Subretinal Administration

Group Type EXPERIMENTAL

LX101

Intervention Type GENETIC

Subretinal administration of LX101 to the contralateral, previously uninjected eye

Interventions

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LX101

Subretinal administration of LX101 to the contralateral, previously uninjected eye

Intervention Type GENETIC

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No