Safety and Efficacy Study of LX103 Treatment of X-Linked Retinoschisis (XLRS)

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

RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-13

Study Completion Date

2028-08-31

Brief Summary

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The goal of this study is to evaluate the safety and efficacy of LX103 treatment of X-linked retinoschisis. This study will enroll subjects aged ≥ 6 years old to receive a single unilateral intravitreal (IVT) injection of LX103 to evaluate its safety and efficacy.

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Detailed Description

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Conditions

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X-linked Retinoschisis

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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LX103 Injection

Potential doses:

5E10 vg, 0.1 mL/eye/dose (low dose)

1E11 vg, 0.05 mL/eye/dose (high dose)

Group Type EXPERIMENTAL

LX103 Injection

Intervention Type GENETIC

Qualified subjects will receive a single unilateral intravitreal injection of LX103 at Day 0 in the trial.

Interventions

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LX103 Injection

Qualified subjects will receive a single unilateral intravitreal injection of LX103 at Day 0 in the trial.

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

1. Willing to sign the informed consent, and willing to attend follow-up visits.
2. Male individual at least 6 years of age with a diagnosis of XLRS and documented mutations in the RS1 gene.
3. The study eye must have a best-corrected E-ETDRS visual acuity letter score of less than or equal to 63.

Exclusion Criteria

1. Any eye with disease that would interfere with the fundus examinations.
2. The study eye is receiving topical carbonic anhydrase inhibitor, or has received topical carbonic anhydrase inhibitors in the past three months.
3. The study eye has undergone intraocular surgery within six months prior to enrollment.
4. Participant has uncontrolled hypertension or diabetes.

Minimum Eligible Age

6 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No