Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma

Launched by AKOUOS, INC. · Jul 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for vestibular schwannoma, which is a type of tumor that affects hearing and balance. Researchers want to see if a gene therapy called AAVAnc80-antiVEGF is safe and well-tolerated when given as a single injection. The trial will also test a special delivery device designed to help administer the treatment effectively. The study is currently looking for participants between the ages of 65 and 74 who have a growing vestibular schwannoma that is larger than 2 mm and have severe hearing loss in the affected ear.

To be eligible for the trial, participants must not have had surgery or radiation therapy for their tumor, and they should not have hearing loss in their other ear. Those who take part in the trial will need to follow specific instructions and agree to participate in a follow-up study after the trial ends. This is an important opportunity for people with vestibular schwannoma to potentially benefit from a new treatment while helping researchers learn more about it.

Gender

ALL

Eligibility criteria

• 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.