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 range18 Years

SexALL

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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.

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