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Virus Therapy

Anti-VEGF Gene Therapy for Acoustic Neuroma

Phase 1 & 2
Recruiting
Research Sponsored by Akouos, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of unilateral, progressive vestibular schwannoma
Vestibular schwannoma larger than 2 mm
Must not have
Prior diagnosis of NF2 and/or participants with bilateral vestibular schwannoma
Prior surgery or radiation therapy for vestibular schwannoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through trial completion, approximately one year
Awards & highlights

Summary

This trial will test the safety and side effects of giving one dose of AAVAnc80-antiVEGF at three different levels using the Akouos delivery device. The trial aims to see if

Who is the study for?
This trial is for individuals with vestibular schwannoma, also known as acoustic neuroma. Participants must meet certain health criteria to be eligible, but specific inclusion and exclusion details are not provided.
What is being tested?
The study tests the safety of a gene therapy called AAVAnc80-antiVEGF delivered through the Akouos device. It will assess three different dose levels administered once unilaterally (to one ear).
What are the potential side effects?
Potential side effects are not detailed in the information provided, but may include reactions at the injection site or systemic responses due to gene therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a growing tumor on my balance nerve in one ear.
Select...
My vestibular schwannoma is larger than 2 mm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with NF2 or have tumors on both hearing nerves.
Select...
I have had surgery or radiation for a brain tumor on my hearing nerve.
Select...
I have experienced fluctuating hearing loss or sudden dizziness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through trial completion, approximately one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through trial completion, approximately one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequency of Adverse Events (AEs)
Secondary study objectives
Performance of Akouos Delivery Device
Tumor Volume

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
Adult participants to receive a single unilateral intracochlear administration of AAVAnc80-antiVEGF (dose level 3) in the study ear using a sterile, one-time use investigational medical device
Group II: Cohort 2Experimental Treatment1 Intervention
Adult participants to receive a single unilateral intracochlear administration of AAVAnc80-antiVEGF (dose level 2) in the study ear using a sterile, one-time use investigational medical device.
Group III: Cohort 1Experimental Treatment1 Intervention
Adult participants to receive a single unilateral intracochlear administration of AAVAnc80-antiVEGF (dose level 1) in the study ear using a sterile, one-time use investigational medical device.

Find a Location

Who is running the clinical trial?

Akouos, Inc.Lead Sponsor
2 Previous Clinical Trials
164 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,640 Previous Clinical Trials
3,221,617 Total Patients Enrolled
Kathy Reape, MDStudy DirectorAkouos, Inc.
2 Previous Clinical Trials
164 Total Patients Enrolled
~18 spots leftby Aug 2029
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