RecruitingPhase 1Phase 2NCT06517888
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
A Phase 1/2 Trial of AAVAnc80-antiVEGF Gene Therapy in Individuals With Unilateral Vestibular Schwannoma
Sponsor
Akouos, Inc.
Enrollment
27 participants
Start Date
Jan 17, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This trial will evaluate the safety and tolerability of a single unilateral administration of one of three dose levels of AAVAnc80-antiVEGF and will evaluate the Akouos delivery device to safely achieve the intended product performance.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- Presence of unilateral, progressive vestibular schwannoma.
- Vestibular schwannoma larger than 2 mm.
- Profound hearing loss, defined by pure-tone audiometry thresholds or word recognition score, in the affected ear.
- Able and willing to comply with all trial requirements, including willingness to participate in a separate long term follow-up study after completion of this trial.
Exclusion Criteria5
- Prior diagnosis of NF2 and/or bilateral vestibular schwannoma.
- Prior surgery or radiation therapy for vestibular schwannoma.
- Clinical history consistent with endolymphatic hydrops (documented fluctuating sensorineural hearing loss and/or episodic vertigo) in the affected ear.
- Profound hearing loss, defined by pure-tone audiometry thresholds or word recognition score, in the unaffected ear.
- Prior participation in a clinical trial with an investigational drug within six months prior to administration (Day 0), or any prior participation in a gene therapy clinical trial.
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Interventions
COMBINATION_PRODUCTAAVAnc80-antiVEGF via Akouos Delivery Device
AAVAnc80-antiVEGF is a sterile suspension intended to be administered via intracochlear administration as a single dose using the Akouos Delivery Device
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT06517888
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