Long Term Follow-up Study of AAVAnc80-antiVEGF Gene Therapy

NCT07503613 | Enrolling By Invitation DMC

• 1 other identifier: AK-antiVegf-LTFU
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This multi-center, observational, post-intervention LTFU study will monitor for safety and efficacy of AAVAnc80- antiVEGF in individuals with vestibular schwannoma who have previously received an intracochlear administration of AAVAnc80-antiVEGF in an interventional clinical trial

Conditions

Vestibular Schwannoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Long term safety of AAVAnc80-antiVEGF, including late-occurring adverse events (AEs

  1. the development of new or exacerbation of malignancies (oncologic), neurologic, rheumatologic or other autoimmune, hematologic disorders, or new infections (if the infection is potentially related to AAVAnc80-antiVEGF) 2. AEs that are related to the IMP and/or the administration procedure 3. AEs of special interest 4. all serious adverse events, regardless of severity

  Through study completion, approximately four years.

Secondary Outcomes (4)

• Tumor Volume

  Through study completion, approximately four years.

• Pure-tone audiometry

  Through study completion, approximately four years.

• Word recognition testing

  Through study completion, approximately four years.

• Otologic questionnaires

  Through study completion, approximately four years.

Study Arms (1)

Study Participants

Individuals with vestibular schwannoma who received an intracochlear administration of AAVAnc80-antiVEGF in an interventional clinical trial.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with vestibular schwannoma who received an intracochlear administration of AAVAnc80-antiVEGF in an interventional clinical trial.

You may qualify if:

• Individual with vestibular schwannoma who received an intracochlear administration of
• AAVAnc80-antiVEGF in an interventional clinical trial.
• Participant willingness to comply with all study requirements as evidenced by successful completion of the informed consent process.

You may not qualify if:

• Any condition that would not allow the potential participant to complete follow-up examinations during the course of the study and/or, in the opinion of the Investigator, makes the potential participant unsuitable for the study.

Sponsors & Collaborators

• Akouos, Inc.: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Neuroma, Acoustic; Hearing Loss

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Hearing Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aaron Tward, MD

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: March 31, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): April 1, 2040
• Study Completion (Estimated): April 1, 2040
• Last Updated: July 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)