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Gene Therapy Trial Report

Summary

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


NCTID NCT06289452 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Retinoschisis, Retinal Disease, Retinal Degeneration, Eye Diseases
Disease Ontology Term DOID:0060763
Compound Name IVB102
Sponsor InnoVec Biotherapeutics Inc.
Funder Type Industry
Recruitment Status
Active not recruiting
Enrollment Count 18 (ESTIMATED)
Results Posted Not Available

Therapy Information


Target Gene/Variant RS1
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Functional gene replacement
Route of Administration Intravitreal
Drug Product Type Viral vector
Delivery System Viral transduction
Vector Type AAV
Editor Type none
Dose 1 Undisclosed low dose
Dose 2 Undisclosed medium dose
Dose 3 Undisclosed high dose

Study Record Dates


Current Stage Early phase1
Submit Date 2024-02-25
Completion Date 2029-12-31
Last Update 2025-04-30

Participation Criteria


Eligible Age >=8 Years
Standard Ages Child, Adult, Older adult
Sexes Eligible for Study MALE
Eligibility Criteria
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.
View Inclusion and Exclusion Criteria at ClinicalTrials.gov

Locations


No.of Trial Sites 1
Locations China

Regulatory Information


Has US IND False
FDA Designations Rare Pediatric Disease Designation
Recent Updates

Resources/Links