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New treatment option for Sensorineural Hearing Loss, Bilateral
Official title Gene Therapy Trial for Otoferlin Gene-mediated Hearing Loss
ClinicalTrials.gov ID: NCT05821959
What this study is testing
What is AAVAnc80-hOTOF via Akouos Delivery Device?
AAVAnc80-hOTOF via Akouos Delivery Device is an investigational medicine, being studied as a potential treatment for sensorineural hearing loss, bilateral.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Part A of this trial will evaluate the safety and tolerability of a single surgical administration procedure in one or both ear(s) with one of two dose levels of AAVAnc80-hOTOF and will evaluate the Akouos Delivery Device, together with the Precision Delivery Mechanism, to safely achieve the intended product performance.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Criteria for Inclusion:
- Participants may be of any age, based on Cohort Criteria
- At least two mutations in the otoferlin gene
- Clinical presentation of Profound bilateral sensorineural hearing loss as assessed by ABR
- Preserved distortion product otoacoustic emissions (DPOAEs)
See the full eligibility criteria
- Criteria for Inclusion:
- Participants may be of any age, based on Cohort Criteria
- At least two mutations in the otoferlin gene
- Clinical presentation of Profound bilateral sensorineural hearing loss as assessed by ABR
- Preserved distortion product otoacoustic emissions (DPOAEs)
- Able and willing to comply with all study requirements, including willingness to participate in a separate long term follow-up study after completion of this trial Criteria for Exclusion:
- Persistent ear infections, anatomic or other abnormalities of the ear, and/or medical conditions that would contraindicate undergoing surgery, anesthesia, and/or administration of investigational gene therapy
- Cochlear Implant(s) in the ear(s) to receive AAVAnc80-hOTOF
- Prior participation in a clinical trial with an investigational drug, within six months prior to administration, or any prior participation in a gene therapy clinical trial
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- Cincinnati, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Toronto, Ontario, Canada
- Taipei, Taiwan
- London, United Kingdom, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Iowa City, Iowa, United States; Boston, Massachusetts, United States; Cincinnati, Ohio, United States; Philadelphia, Pennsylvania, United States; Nashville, Tennessee, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.