Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy

Conditions

• Otoferlin Gene-mediated Hearing Loss

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Study Details

This multi-center, observational, post-intervention long term follow-up (LTFU) study will monitor for safety and efficacy of AAVAnc80-hOTOF in individuals with sensorineural hearing loss due to otoferlin gene mutations who have previously received intracochlear administration of AAVAnc80-hOTOF in the AK-OTOF-101 Clinical Trial.

Key Dates

First listed

Nov 20, 2024

Start date

Nov 11, 2024

Status verified

Feb 2026

Primary completion

Apr 30, 2033

Completion

Apr 30, 2033

Study Design

Enrollment

30 participants (estimated)

Arms

• Arm: Study Participants
  Individuals with otoferlin gene-mediated hearing loss who received intracochlear administration of AAVAnc80-hOTOF in the AK-OTOF-101 Clinical Trial

Primary Outcome Measure

Long term safety of AAVAnc80-hOTOF, including the incidence and frequency of late-occurring adverse events (AEs) [ Time Frame: Through study completion, approximately four years. ]

Locations (3)

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