This study evaluates the safety and efficacy of IVB102 injection, a gene therapy, in people with X-linked retinoschisis caused by mutations in the RS1 gene. It enrolls male patients at least 8 years old with a clinical diagnosis of XLRS who meet certain visual acuity criteria. The study is in Early Phase 1 and is active but not currently recruiting.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Must be willing and able to provide written, signed informed consent. 2. Male individual at least 8 years of age with clinical diagnosis of XLRS caused by mutations in RS1. 3. Best corrected visual acuity (BCVA) in the study eye of less than or equal to 63 (corresponding to a Snellen acuity of 20/63). 4. Must agree to use effective barrier (male or female condom) of contraception before dosing and continuing one year after gene transfer. Exclusion Criteria: 1. Lens, cornea, or other media opacities in the study eye that preclude adequate visualization and testing of the retina. 2. 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). 3. Any intraocular surgery in the study eye within 6 months prior to screening. 4. Use of topical carbonic anhydrase inhibitors within 3 months prior to screening. 5. Use of anticoagulants or anti-platelet agents within 7 days prior to study agent administration. 6. Prior receipt of any AAV gene therapy product. 7. Use of any investigational agent within 3 months prior to screening.