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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

No Placebo-Only Group

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

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I have a growing tumor on my balance nerve in one ear.

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My vestibular schwannoma is larger than 2 mm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with NF2 or have tumors on both hearing nerves.

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I have had surgery or radiation for a brain tumor on my hearing nerve.

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I have experienced fluctuating hearing loss or sudden dizziness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through trial completion, approximately one year

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met