RecruitingPhase 1/2

Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma

United States27 participantsStarted 2025-01-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frequency of Adverse Events (AEs)

Timeframe: through trial completion, approximately one year

Trial details

NCT IDNCT06517888

SponsorAkouos, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-08

Contact for this trial

Akouos Clinical Trials

+1 (857) 410-1816 AkouosClinicalTrials@Lilly.com

View on ClinicalTrials.gov More Vestibular Schwannoma trials