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

Sponsored by InnoVec Biotherapeutics Inc.

About this trial

Last updated a year ago

Study ID

IVB102-101

Status

Active not recruiting

Type

Interventional

Phase

Early Phase 1

Placebo

No

Accepting

8+ Years
Male

Trial Timing

Started 2 years ago

What is this trial about?

The goal of this clinical trial is to evaluate the safety and efficacy of IVB102 injection in subjects with XLRS.

What are the participation requirements?

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.