Overview
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
Criteria for Inclusion:
- 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.
Criteria for Exclusion:
- 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.