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 groupsSponsors and collaborators
Akouos, Inc.
Lead sponsor
Eli Lilly and Company
Collaborator
Source ClinicalTrials.gov