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Active, not recruitingNCT06289452Updated Apr 30, 2025

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

An Early Phase 1 interventional study of IVB102 Injection and IVB102 Injection in Retinoschisis, Retinal Disease and Retinal Degeneration, sponsored by InnoVec Biotherapeutics Inc.. Active, not recruiting at 1 site in China. Open to male participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2025-04-30.

Sponsored by InnoVec Biotherapeutics Inc. · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as active, not recruiting.
Phase
Early Phase 1
Study type
Interventional
Enrollment
18
Allocation
Non-randomized
Ages
8 Years and older
Sex
Male
01

Study summary

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

Read the detailed 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.

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Conditions studied

  • Retinoschisis
  • Retinal Disease
  • Retinal Degeneration
  • Eye Diseases
03

In context

Eye Diseases

741 studies on the registry are indexed under Eye Diseases; 118 are open to participants now.

This study's planned enrollment of 18 is below the median of 69 across 548 interventional studies indexed under Eye Diseases.

Browse Eye Diseases studies →

Lead sponsor

InnoVec Biotherapeutics Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years and older
Sexes eligible
Male
Accepts 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

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
18 participants (estimated)

Study arms

  • Experimental
    IVB102 Treatment Arm（Low dose）

    Intraocular injection of a single low dose of IVB102

    Genetic: IVB102 Injection

  • Experimental
    IVB102 Treatment Arm（Intermediate dose）

    Intraocular injection of a single intermediate dose of IVB102

    Genetic: IVB102 Injection

  • Experimental
    IVB102 Treatment Arm（High dose）

    Intraocular injection of a single high dose of IVB102

    Genetic: IVB102 Injection

Interventions

  • GeneticIVB102 Injection

    Gene transfer by intravitreal injection of the RS1 AAV vector

  • GeneticIVB102 Injection

    Gene transfer by intravitreal injection of the RS1 AAV vector

  • GeneticIVB102 Injection

    Gene transfer by intravitreal injection of the RS1 AAV vector

06

What researchers measure

Primary outcomes

  1. Incidence of DLTs

    Number and proportion of dose limited toxicity（DLTs）

    Time frame: 4 weeks

  2. Incidence of AEs

    Number and severity of overall and ocular Adverse Events (AEs)

    Time frame: 52 weeks

  3. Incidence of SAEs

    Number and severity of overall and ocular Serious Adverse Events (SAEs)

    Time frame: 52 weeks

Secondary outcomes

  1. Visual function

    Change from baseline in BCVA(Best Corrected Visual Acuity)(ETDRS)

    Time frame: 52 weeks

  2. OCT imaging

    Change from baseline in CST(Central Retinal Thickness)(OCT)

    Time frame: 52 weeks

  3. ERG parameters

    Change from baseline in response amplitudes measured using Electroretinogram (ERG)

    Time frame: 52 weeks

07

Study locations

1 site
  • Peking Union Medical College Hospital
    Beijing, Beijing 100142, China
08

References and documents

Publications

  • Pimenides D, George ND, Yates JR, Bradshaw K, Roberts SA, Moore AT, Trump D. X-linked retinoschisis: clinical phenotype and RS1 genotype in 86 UK patients. J Med Genet. 2005 Jun;42(6):e35. doi: 10.1136/jmg.2004.029769. PubMed 15937075 ↗
  • Wang XF, Chen FF, Zhou X, Cheng XX, Xie ZG. A novel mutation in RS1 and clinical manifestations in a Chinese twin family with congenital retinoschisis. Front Genet. 2022 Sep 23;13:993157. doi: 10.3389/fgene.2022.993157. eCollection 2022. PubMed 36212125 ↗
  • Sikkink SK, Biswas S, Parry NR, Stanga PE, Trump D. X-linked retinoschisis: an update. J Med Genet. 2007 Apr;44(4):225-32. doi: 10.1136/jmg.2006.047340. Epub 2006 Dec 15. PubMed 17172462 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06289452
Lead sponsor
InnoVec Biotherapeutics Inc.
Collaborators
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
Mar 1, 2024
Start date
Mar 8, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Apr 30, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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