A Phase 1/2 Trial of AAVAnc80-antiVEGF Gene Therapy in Individuals With Unilateral Vestibular Schwannoma
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Presence of unilateral, progressive vestibular schwannoma.
• Vestibular schwannoma larger than 2 mm.
• Profound hearing loss, defined by pure-tone audiometry thresholds or word recognition score, in the affected ear.
• Able and willing to comply with all trial requirements, including willingness to participate in a separate long term follow-up study after completion of this trial.
Locations
United States
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
Minnesota
Mayo Clinic
RECRUITING
Rochester
Tennessee
Vanderbilt Bill Wilkerson Center
RECRUITING
Nashville
Texas
University of Texas Southwestern
RECRUITING
Dallas
Contact Information
Primary
Akouos Clinical Trials
AkouosClinicalTrials@Lilly.com
+1 (857) 410-1816
Time Frame
Start Date: 2025-01-17
Estimated Completion Date: 2029-08
Participants
Target number of participants: 27
Treatments
Experimental: Cohort 1
Adult participants to receive a single unilateral intracochlear administration of AAVAnc80-antiVEGF (dose level 1) in the study ear using a sterile, one-time use investigational medical device.
Experimental: Cohort 2
Adult participants to receive a single unilateral intracochlear administration of AAVAnc80-antiVEGF (dose level 2) in the study ear using a sterile, one-time use investigational medical device.
Experimental: Cohort 3
Adult participants to receive a single unilateral intracochlear administration of AAVAnc80-antiVEGF (dose level 3) in the study ear using a sterile, one-time use investigational medical device
Related Therapeutic Areas
Sponsors
Collaborators: Eli Lilly and Company
Leads: Akouos, Inc.