A three-part, multi center, 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
Sponsor: |
Novartis |
Enrolling: |
Male and Female Patients |
Clinic Visits: |
13 |
IRB Number: |
AAAO3114 |
U.S. Govt. ID: |
NCT02132130 |
Contact: |
Jessica Campbell: 212-305-2298 / jc4353@cumc.columbia.edu |
The purpose of this research is to find out whether it is safe to use a virus to deliver a new gene to the inner ear of people with hearing loss. This is a kind of gene therapy which involves gene transfer. Once the genetic material and vector are surgically administered to you, it is not possible to remove these agents. The study is designed to evaluate the safety, tolerability, and the potential ability of CGF166 to improve hearing and balance (vestibular function). CGF166 is a weakened virus, made in a laboratory, that carries the Atonal gene. CGF166 is expected to help existing cells (supporting cells) in your inner ear become new, functional sensory hair cells.
This study is closed
Investigator
Lawrence Lustig, MD
Do you have severe-to-profound hearing loss in both ears? |
Yes |
No |
Is your hearing loss caused by genetic/developmental disorders? |
Yes |
No |
Have you ever been diagnosed with Meniere's disease? |
Yes |
No |