(Updated January 2018)
Alongside research to find ways of restoring vision through stem cell therapy and gene therapy, attempts are being made to restore vision electronically by means of bionic implants. In past reports, we have described the ARGUS-2, which has shown success in providing a basic pixelated sense of sight to the totally blind.
In October 2017, Pixium Vision received French authorization to begin a feasibility study in human patients with advanced dry age-related macular degeneration (dry AMD). The company earlier presented information about their newest bionic device called PRIMA–a tiny wireless sub-retinal implant that can provide prosthetic vision at the speed of video, a decided advancement over current imaging.
“The approval of the clinical study is a significant advance for the PRIMA system,” said Pixium’s CEO Khalid Ishaque. “Conceived initially by the researchers at Stanford University and successfully developed through to clinical stage by our team . . . PRIMA enters an exciting phase of its development, with a first patient expected to be implanted before year end.”
The clinical study entitled “Feasibility Study of Compensation for blindness with the PRIMA system in patients with dry age related macular degeneration”, is designed to evaluate the tolerance of PRIMA and to demonstrate the evoked central visual perception among patients who have lost their sight due to atrophic (advanced dry) AMD. The study is planned to recruit 5 patients with interim evaluation at 6-month follow-up and longer term follow-up to 36 months. The study will be conducted at Fondation Ophtalmologique Rothschild and Hôpital des Quinze-Vingt in Paris with Dr. Yannick Le Mer, vitreoretinal surgeon and ophthalmologist, as principal investigator.
In January 2018, the FDA approved a clinical feasibility study of PRIMA implant to be conducted at the University of Pittsburgh Medical Center. Like the French study, this will recruit up to five patients with vision loss that results from Atrophic AMD. The primary endpoint again being restoration of visual perception, as well as safety at a 12-month follow-up with a longer-term follow-up duration of 36 months. Pixium Vision expects to start the US study in the first half of 2018.
SOURCE: Press Release