Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Akouos, Inc.
Study ID
NCT06517888
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Vestibular Schwannoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AAVAnc80-antiVEGF via Akouos Delivery Device — COMBINATION_PRODUCT
    AAVAnc80-antiVEGF is a sterile suspension intended to be administered via intracochlear administration as a single dose using the Akouos Delivery Device

Study Details

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.

Key Dates

Start date
Jan 17, 2025
Status verified
Oct 2025
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
27 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Frequency of Adverse Events (AEs) [ Time Frame: through trial completion, approximately one year ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21205
[email protected]
+1 (410) 955 3157
Mayo ClinicRochesterMinnesota55905
Dan Osland
[email protected]
+1 507-266-1470
Vanderbilt Bill Wilkerson CenterNashvilleTennessee37232
Taha Jan, MD
[email protected]
+1 (615) 322-4386
University of Texas SouthwesternDallasTexas75390
[email protected]
+1 (214) 648-3626

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Johns Hopkins Hospital· Baltimore, MDMayo Clinic· Rochester, MNVanderbilt Bill Wilkerson Center· Nashville, TNUniversity of Texas Southwestern· Dallas, TX

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