Gene therapy for vestibular schwannoma treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the safety and tolerability of a single unilateral administration of AAVAnc80-antiVEGF at three different dose levels. It also assesses the Akouos delivery device's effectiveness in achieving the desired therapeutic outcome. The focus is on patients with unilateral, progressive vestibular schwannoma larger than 2 mm and associated profound hearing loss. Participants will be monitored for their compliance with trial requirements and will be invited to join a long-term follow-up study.

Why it matters

Who can join: the full rules

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.

Where it's running

• Johns Hopkins Hospital
  Baltimore, Maryland, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting
• Vanderbilt Bill Wilkerson Center
  Nashville, Tennessee, United States Recruiting
• University of Texas Southwestern
  Dallas, Texas, United States Recruiting

Study contacts

• Study coordinator: Lilly Clinical Trials
• Email: AkouosClinicalTrials@Lilly.com
• Phone: +1 (857) 410-1816

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• 3D MRI Elastography to Peek at Vestibular Schwannoma Stiffness and How It Relates to Surgery

  This study tests whether 3D MRI elastography can noninvasively measure how stiff vestibular schwannomas are and how firmly they stick to nearby tissues, to help predict surgical difficulty and outcomes.

  Recruiting Shengjing Hospital · Shenyang, Liaoning · NCT07844460

• Vestibular rehabilitation for adults having surgery for a unilateral vestibular schwannoma

  This trial tests whether home-based vestibular telerehabilitation before and after surgery, and adding preoperative rotatory chair sessions, can help adults recover balance and reduce dizziness after removal of a unilateral vestibular schwannoma.

  Recruiting Universitat Autonoma de Barcelona · Badalona, Barcelona · NCT07364955

• Testing brain vestibular centers after vestibular schwannoma surgery with MRI

  We’re testing whether brain areas that control balance light up differently in people after vestibular schwannoma surgery compared to healthy individuals using MRI.

  Recruiting Charles University, Czech Republic · Prague · NCT07130851

• Steroids to protect facial nerve function after skull-base surgery for vestibular schwannoma

  This trial tests whether giving steroids after vestibular schwannoma surgery helps preserve facial nerve function compared with a placebo.

  Recruiting Phase 3 Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT07116811

• Rehabilitation for patients with vestibular deficits using head impulse testing

  This study is testing a new rehabilitation method using head movement exercises to help people with balance issues from vestibular problems, like vestibular schwannoma, see if it improves their eye and balance function compared to a simple eye movement treatment.

  Recruiting Hospices Civils de Lyon · Bron · NCT06660082

• Using special MRI to detect inflammation in brain tumors

  This study is testing a special MRI technique that uses a contrast agent to see if it can help doctors spot inflammation in brain tumors like vestibular schwannomas and gliomas.

  Recruiting Northern Care Alliance NHS Foundation Trust · Salford, Greater Manchester · NCT06572475

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.