Study objective: The goal of this study is to assess the safety and tolerability of an inner ear infusion of CGF166, a gene therapy. Another goal is to assess the effectiveness of CGF166 by measuring changes in hearing before and after treatment. Some of the possible benefits that researchers believe CGF166 may provide include improved hearing that may be revealed as improved speech recognition, and the ability to benefit from a hearing aid and avoid the need for a cochlear implant.
Am I eligible? Participants should be 18 to 75 years of age with severe hearing loss in both ears. You will be unable to participate if your hearing loss was caused by genetic/developmental disorders, surgery, or trauma. Also, participants will be excluded if they have cochlear implants, Meniere's disease, or immunodeficiency diseases.
What is involved? Participation lasts approximately 7 months with 13 visits to the clinic. During a screening period, participants will be thoroughly evaluated for auditory (hearing) and vestibular (balance) function. Those who qualify will receive an operation and the study drug will be injected into the inner ear. The study drug, CGF166, is a gene therapy. Gene therapy is an experimental technique that uses genes to treat disease. The technique allows doctors to insert a gene into a patient's cells in an effort to treat their hearing loss. This is done with a common flu-type virus that has been weakened so it can't multiply and carries the gene that is expected to help existing cells in the inner ear to become new functional hair cells. Participants will be followed in the clinic for a minimum of 169 days after surgery. These follow-up visits will include auditory and vestibular testing similar to the testing performed before the surgery.