Safety and Efficacy Study of LX103 Treatment of X-Linked Retinoschisis (XLRS)
An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Efficacy of LX103 in Patients With X-Linked Retinoschisis (XLRS)
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
12 participants
Dec 13, 2022
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria3
- 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.
Exclusion Criteria4
- 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.
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Interventions
Qualified subjects will receive a single unilateral intravitreal injection of LX103 at Day 0 in the trial.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05814952