RECRUITING

Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This trial will evaluate the safety and tolerability of a single unilateral administration of one of three dose levels of AAVAnc80-antiVEGF and will evaluate the Akouos delivery device to safely achieve the intended product performance.

Official Title

A Phase 1/2 Trial of AAVAnc80-antiVEGF Gene Therapy in Individuals With Unilateral Vestibular Schwannoma

Quick Facts

Study Start:2024-09
Study Completion:2029-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06517888

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Akouos Clinical Trials
CONTACT
+1 (857) 410-1816
clinicaltrials@akouos.com

Principal Investigator

Kathy Reape, MD
STUDY_DIRECTOR
Akouos, Inc.

Study Locations (Sites)

Mayo Clinic
Rochester, Minnesota, 55905
United States
University of Texas Southwestern
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: Akouos, Inc.

  • Kathy Reape, MD, STUDY_DIRECTOR, Akouos, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09
Study Completion Date2029-08

Study Record Updates

Study Start Date2024-09
Study Completion Date2029-08

Terms related to this study

Keywords Provided by Researchers

  • Vestibular schwannoma
  • Hearing loss
  • Acoustic neuroma
  • anti-VEGF

Additional Relevant MeSH Terms

  • Vestibular Schwannoma