Session Title: New Drug Treatment
Session Date/Time: Saturday 13/09/2014 | 14:30-16:30
Paper Time: 14:54
Venue: Boulevard F
First Author: : G.Cosendai SWITZERLAND
Co Author(s): : L. da Cruz J. Sahel P. Stanga F. Hafezi R. Greenberg A. Study Group
Subjects in the Argus II trial, the largest clinical trial of a retinal prosthesis in the world, continue to be followed for safety and performance. All 30 subjects in the trial (clinicaltrials.gov NCT00407602) had bare light perception or worse in both eyes due to severe outer retinal degeneration before implant.
There were 10 implanting centers in the clinical trial in the US, Switzerland, France, and the UK.
Safety was evaluated by recording the number, type, and severity of adverse events. Visual function was evaluated by high-contrast computer tests such as Square Localization, Direction of Motion, and Grating Visual Acuity. Functional Vision was evaluated with Orientation and Mobility tests and the Functional Low-vision Observer Rated Assessment (FLORA). All assessments are performed with the System ON and OFF to compare Argus II performance against subjects’ residual vision.
To date, this trial has gathered 160 subject-years of data. As of February 20, 2014, 25 subjects remain implanted with functioning Argus II implants. There have been three explants, two of which were elective, and two device failures (i.e., a failure to maintain communications link). On average, these 25 subjects have been implanted for 5.6 years (range of 4.5 – 6.7 years). The long-term safety profile remains very good; there was only one new non-serious adverse event (related to the device or the procedure) among all subjects in the last year. Performance on all assessments shows better function with the System ON than OFF, sustained beyond 5 years of use.
The latest results confirm previous reports on the long-term safety and functioning of the Argus II Retinal Prosthesis System. The Argus II is commercially available in the US, Europe, and the Middle East.