Safety, Tolerability and Efficacy for CGF166 in Patients With Unilateral or Bilateral Severe-to-profound Hearing Loss
A Three-part, Multicenter, Open Label, Single Dose Study to Assess the Safety, Tolerability, and Efficacy of Intra Labyrinthine (IL) CGF166 in Patients With Severe-to-profound Hearing Loss
Doctors at Novartis study centers in KA and OR seek patients with unilateral or bilateral severe-to-profound hearing loss to trial an investigational gene therapy, called CGF166, that uses a viral shell to deliver a gene that can prompt growth of inner-ear hair filaments and possibly improve hearing. The study would require a single intra-labyrinthine (inner-ear) infusion of the drug, then 24 months of follow up to track any negative reactions and hearing improvements.
- Up to 18 to 75 years of age
- Have severe-to-profound bilateral hearing loss or unilateral hearing loss with intact vestibular function in the nonoperative ear. Non-fluctuating severe-to-profound hearing loss is required for the study ear and is defined as:
- PTA within 10 dB of the PTA obtained at least 11 months previously
- Word recognition within 20% of previous test at least 11 months previously
- Meet residual hearing criteria and vestibular function in the ear that will be studied
THE STUDY INVOLVES:
- Prescreening to confirm eligibility of the patient to participate.
- Single intra-labyrinthine (inner-ear) infusion of the drug to a single “study ear”.
- Follow up will continue for up to 2 years.
LOCATIONS AND CONTACTS:
The study sites are in Kansas City, KA, and Portland, OR. To learn where, contact the trial coordinator below.