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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age6+
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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.

Eligibility criteria

Qualifiers

Willing to sign the informed consent, and willing to attend follow-up visits.

Male individual at least 6 years of age with a diagnosis of XLRS and documented mutations in the RS1 gene.

The study eye must have a best-corrected E-ETDRS visual acuity letter score of less than or equal to 63.

Disqualifiers

Any eye with disease that would interfere with the fundus examinations.

The study eye is receiving topical carbonic anhydrase inhibitor, or has received topical carbonic anhydrase inhibitors in the past three months.

The study eye has undergone intraocular surgery within six months prior to enrollment.

Participant has uncontrolled hypertension or diabetes.

Trial design

Treatments tested in this trial

  • LX103 Injection

Treatment groups

12 Participants
are divided into 1 treatment group

Sponsors and collaborators