Clinical trial for Vestibular Schwannoma
Official title Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
ClinicalTrials.gov ID: NCT06517888
What this study is testing
What is AAVAnc80-antiVEGF?
an investigational combination product being studied as a potential treatment for vestibular schwannoma. is designed to deliver a gene that produces an anti‑VEGF protein inside the inner ear to help limit tumor blood vessel growth.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if the new treatment is safe and how well the body tolerates it. It also checks if the special device used to deliver the medicine works as intended.
- Who it's for
- People who have a vestibular schwannoma, which is a non-cancerous tumor on the nerve that controls balance.
- What's involved
- Participants will receive a one-time injection of the gene therapy into one ear using a special delivery device. Doctors will monitor you closely to see how you react to the treatment.
- Time commitment
- The study involves a single treatment session, but you will need to return for follow-up visits to check your safety and health.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
- Prior diagnosis of NF2 and/or bilateral vestibular schwannoma.
- Prior surgery or radiation therapy for vestibular schwannoma.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Baltimore, Maryland, United States
- Rochester, Minnesota, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Baltimore, Maryland, United States; Rochester, Minnesota, United States; Nashville, Tennessee, United States; Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.