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Bored Studies
RecruitingPhase 1/Phase 2

Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma

Akouos, Inc. · with Eli Lilly and Company · NCT06517888

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
27
US sites recruiting
4
Study start
January 17, 2025
Record last updated
April 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: AAVAnc80-antiVEGF via Akouos Delivery Device

Conditions: Vestibular Schwannoma

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Johns Hopkins Hospital

    Baltimore, MD 21205

    Site contact: +1 (410) 955 3157 · ototrials@live.johnshopkins.edu

  • Mayo Clinic

    Rochester, MN 55905

    Site contact: Dan Osland · +1 507-266-1470 · Osland.daniel@mayo.edu

  • Vanderbilt Bill Wilkerson Center

    Nashville, TN 37232

    Site contact: Taha Jan, MD · +1 (615) 322-4386 · Taha.a.jan@vumc.org

  • University of Texas Southwestern

    Dallas, TX 75390

    Site contact: +1 (214) 648-3626 · OTOResearch@UTSouthwestern.edu

Study contacts (from the official record)

  • Akouos Clinical Trials · +1 (857) 410-1816 · AkouosClinicalTrials@Lilly.com
All phase 1 studies in Maryland →
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma (NCT06517888) | Bored Studies