Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

27 Participants
are divided into 3 treatment groups
Group A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Group C: Cohort 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of Adverse Events (AEs)

AEs with relationship to the investigational medicinal product and/or to the administration procedure (including the delivery device)

Time frame
through trial completion, approximately one year

Secondary outcomes

1

Tumor Volume

Change from baseline in tumor size via MRI (volumetric analysis)

Time frame
through trial completion, approximately one year
2

Performance of Akouos Delivery Device

Performance based on the frequency of device deficiencies observed during delivery of AAVAnc80-antiVEGF to the intracochlear space

Time frame
through trial completion, approximately one year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Akouos, Inc.

Lead sponsor

Eli Lilly and Company

Collaborator

Source ClinicalTrials.gov
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