Safety and Efficacy Study of IVB102 Injection in Subjects With X-linked Retinoschisis

This is a open label, dose escalation, single-center study. One eye of each participant will receive a single IVB102 injection by intravitreal injection. Participants will be followed for 52 weeks after which they will continue to be followed for up to 5 years after enrollment.

Inclusion criteria

• Must be willing and able to provide written, signed informed consent.
• Male individual at least 8 years of age with clinical diagnosis of XLRS caused by mutations in RS1.
• Best corrected visual acuity (BCVA) in the study eye of less than or equal to 63 (corresponding to a Snellen acuity of 20/63).
• Must agree to use effective barrier (male or female condom) of contraception before dosing and continuing one year after gene transfer.

Exclusion criteria

• Lens, cornea, or other media opacities in the study eye that preclude adequate visualization and testing of the retina.
• Pre-existing eye conditions that would contribute significantly to visual loss or increase the risk of an intravitreal injection (e.g. DR、RVO or large retinal detachment).
• Any intraocular surgery in the study eye within 6 months prior to screening.
• Use of topical carbonic anhydrase inhibitors within 3 months prior to screening.
• Use of anticoagulants or anti-platelet agents within 7 days prior to study agent administration.
• Prior receipt of any AAV gene therapy product.
• Use of any investigational agent within 3 months prior to screening.