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
Sponsors and collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead sponsor
Innostellar Biotherapeutics
Collaborator