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.
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.
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.
Single group
LX103 Injection
GeneticQualified subjects will receive a single unilateral intravitreal injection of LX103 at Day 0 in the trial.
Incidence of adverse events (AEs)
Incidence of adverse events (AEs) within 24 weeks of LX103 intravitreal injection at different doses
Incidence of serious adverse events (SAEs)
Incidence of serious adverse events (SAEs) within 24 weeks of LX103 intravitreal injection at different doses
Mean change from baseline in BCVA (LogMAR) in the study eye
ETDRS visual acuity charts will be used to assess BCVA
Mean change from baseline in central subfield thickness (CST) in the study eye
Mean change of CST measured using Optical Coherence Tomography (OCT)
Change from baseline in Electroretinogram (ERG) parameters in the study eye
Change in dark-adapted 3.0 B-wave amplitude (μV)
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead sponsor
Innostellar Biotherapeutics
Collaborator
