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Clinical Trials in the USA / NCT06517888
Recruiting Phase 1/2

Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma

NCT06517888 · tracked via the Priya Life Science USA tracker
Sponsor
Akouos, Inc.
Phase
Phase 1/2
Started
2025-01-17
Last updated
2026-04-06

Condition(s) studied

Vestibular Schwannoma

Investigational drug(s) / intervention(s)

AAVAnc80-antiVEGF via Akouos Delivery Device

AAVAnc80-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

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Criteria for Inclusion: 1. Presence of unilateral, progressive vestibular schwannoma. 2. Vestibular schwannoma larger than 2 mm. 3. Profound hearing loss, defined by pure-tone audiometry thresholds or word recognition score, in the affected ear. 4. 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: 1. Prior diagnosis of NF2 and/or bilateral vestibular schwannoma. 2. Prior surgery or radiation therapy for vestibular schwannoma. 3. Clinical history consistent with endolymphatic hydrops (documented fluctuating sensorineural hearing loss and/or episodic vertigo) in the affected ear. 4. Profound hearing loss, defined by pure-tone audiometry thresholds or word recognition score, in the unaffected ear. 5. 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.

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Johns Hopkins Hospital Baltimore Maryland Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Vanderbilt Bill Wilkerson Center Nashville Tennessee Recruiting
University of Texas Southwestern Dallas Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06517888 on ClinicalTrials.gov ↗ ← All trials in the USA