IVB102 Injection: Gene transfer by intravitreal injection of the RS1 AAV vector
IVB102 Injection: Gene transfer by intravitreal injection of the RS1 AAV vector
IVB102 Injection: Gene transfer by intravitreal injection of the RS1 AAV vector
Study summary
The goal of this clinical trial is to evaluate the safety and efficacy of IVB102 injection in subjects with XLRS.
Eligibility
Sex
MALE
Min age
8 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence of DLTs — 4 weeks Number and proportion of dose limited toxicity（DLTs）
Incidence of AEs — 52 weeks Number and severity of overall and ocular Adverse Events (AEs)
Incidence of SAEs — 52 weeks Number and severity of overall and ocular Serious Adverse Events (SAEs)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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