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

Eye Diseases Clinical Trial

Official title:

An Open-label, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IVB102 Injection in Subjects With X-linked Retinoschisis (XLRS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06289452
• Other study ID #: IVB102-101
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 8, 2024
• Est. completion date: December 31, 2029

Study information

• Verified date: February 2024
• Source: InnoVec Biotherapeutics Inc.
• Contact: Cheng Wang
• Phone: +8613611238062
• Email: clinicaltrial[@]innovecbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is a open label, dose escalation, single-center study. One eye of each participant will receive a single IVB102 injection by intravitreal injection. Participants will be followed for 52 weeks after which they will continue to be followed for up to 5 years after enrollment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 8 Years and older

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.

Related Conditions & MeSH terms

• Eye Diseases
• Retinal Degeneration
• Retinal Disease
• Retinal Diseases
• Retinoschisis

Intervention

Genetic:
• 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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
InnoVec Biotherapeutics Inc.	Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of DLTs	Number and proportion of dose limited toxicity(DLTs)	4 weeks
Primary	Incidence of AEs	Number and severity of overall and ocular Adverse Events (AEs)	52 weeks
Primary	Incidence of SAEs	Number and severity of overall and ocular Serious Adverse Events (SAEs)	52 weeks
Secondary	Visual function	Change from baseline in BCVA(Best Corrected Visual Acuity)(ETDRS)	52 weeks
Secondary	OCT imaging	Change from baseline in CST(Central Retinal Thickness)(OCT)	52 weeks
Secondary	ERG parameters	Change from baseline in response amplitudes measured using Electroretinogram (ERG)	52 weeks