Safety and Efficacy Study of IVB102 Injection in Subjects With X-linked Retinoschisis (NCT06289452) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Safety and Efficacy Study of IVB102 Injection in Subjects With X-linked Retinoschisis
China18 participantsStarted 2024-03-08
Plain-language summary
The goal of this clinical trial is to evaluate the safety and efficacy of IVB102 injection in subjects with XLRS.
Who can participate
Age range
8 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.