NCT07503613

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

An Evaluation of the Long Term Safety and Efficacy of AAVAnc80-antiVEGF Gene Therapy in Individuals With Vestibular Schwannoma

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Akouos, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

After completing one year of initial safety and efficacy assessments following an intracochlear administration of AAVAnc80-antiVEGF, participants will continue to be observed for an additional approximately four years of safety and efficacy follow-up in this LTFU study, for a total of approximately five years observations after product administration. For each participant, evaluations in the LTFU study will occur at annual visits through Year 5; with the aim to characterize long-term safety, including potential delayed adverse events, as well as characterizing the durability of effect of AAVAnc80-antiVEGF

Conditions

• Vestibular Schwannoma

Timeline

• Start date: 2026-03-02
• Primary completion: 2040-04-01
• Completion: 2040-04-01
• First posted: 2026-03-31
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States