Clin2
NCT05788536Possibly a fitRecruiting

Gene therapy study for OTOF-related hearing loss

Congenital Hearing Loss Secondary to Biallelic Mutations of the Otoferlin Gene (OTOF)

Part of Brain & nervous system, Ear, nose & throat clinical trials.

This trial tests a one-time gene therapy delivered into the ear to improve hearing in people with certain OTOF gene changes. It studies safety and how well the treatment can work, especially in children and infants, as doctors monitor hearing tests for up to 48 weeks.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 1/Phase 2
Enrollment
36 people
Ages
Any age
Study type
Interventional

Who can take part

  • You (or your child’s parent/guardian) agree to sign consent and follow the study plan
  • You agree to gene testing to confirm the participant has OTOF-related genetic hearing loss
  • You agree to age-appropriate vaccinations, as the study requires
  • The study can do the needed hearing and other checkup tests at screening
  • Genetic testing must show two bad (likely) OTOF gene changes (biallelic pathogenic/likely pathogenic)
  • The ear to be treated must have exam results showing the outer hair cells are still working

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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