Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
NCT06517888 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2026-04-06
Summary
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.
Conditions
- Vestibular Schwannoma
Interventions
- COMBINATION_PRODUCT
-
AAVAnc80-antiVEGF via Akouos Delivery Device
AAVAnc80-antiVEGF is a sterile suspension intended to be administered via intracochlear administration as a single dose using the Akouos Delivery Device
Sponsors & Collaborators
- collaborator INDUSTRY
-
Akouos, Inc.
lead INDUSTRY
Principal Investigators
-
Aaron Tward, MD · Eli Lilly and Company
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-17
- Primary Completion
- 2029-08-31
- Completion
- 2029-08-31
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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