Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
ConditionVestibular Schwannoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAkouos, Inc.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
None
Trial design
Treatments tested in this trial
- AAVAnc80-antiVEGF via Akouos Delivery Device
Treatment groups
27 Participants
are divided into 3 treatment groupsLocations
4Johns Hopkins Hospital21205, BaltimoreMaryland, United States
Mayo Clinic55905, RochesterMinnesota, United States
Vanderbilt Bill Wilkerson Center37232, NashvilleTennessee, United States
University of Texas Southwestern75390, DallasTexas, United States
Sponsors and collaborators
Akouos, Inc.
Lead sponsor
Eli Lilly and Company
Collaborator
Source ClinicalTrials.gov