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Clinical Trials in the USA / NCT07503613
Enrolling by invitation Observational

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

NCT07503613 · tracked via the Priya Life Science USA tracker
Sponsor
Akouos, Inc
Phase
Observational
Started
2026-03-02
Last updated
2026-07-16

Condition(s) studied

Vestibular Schwannoma

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: -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. Exclusion Criteria: -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.

Primary outcome measure(s)

  • Long term safety of AAVAnc80-antiVEGF, including late-occurring adverse events (AEs — Through study completion, approximately four years.
    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

Trial sites (1)

FacilityCityRegionStatus
University of Texas Southwestern Dallas Texas

More Akouos, Inc. trials in the USA

Otoferlin Gene-mediated Hearing Loss Natural History Study Recruiting
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma Recruiting
Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy Enrolling by invitation

Other trials for the same condition

Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07503613 on ClinicalTrials.gov ↗ ← All trials in the USA