Prof. Daniel Palanker (Hanses Experimental Physics Laboratory, Stanford University, Stanford, California, USA).

Dr. Yannik Le Mer (Fondation Adolphe Rotschild, Paris, France).

Retinal prostheses are medical devices that are implanted inside the eye, on or under the retina of patients with severe vision loss caused by progressive atrophy of photoreceptors (rods and cones), the cells responsible for vision. Age-related macular degeneration (AMD) and retinitis pigmentosa (RP) are the two most common retinal degenerative disorders.

AMD is a multifactorial disease that affects older people, over the age of 55-60, and whose atrophic form gradually impairs fine and detailed vision, eventually leading to central vision loss and legal blindness in its end-stage known as geographic atrophy (GA). Retinitis pigmentosa (RP) is a genetically inherited disease that affects younger people, from early childhood to the third decade, often causing night blindness, gradual loss of peripheral vision and eventually legal or complete blindness before the age of 40.

Until today there is no treatment for atrophic AMD and RP besides sun-protection strategies and vitamin supplementation, which can slow down their progression. A novel retinal prosthesis based on a sub-retinal wireless microchip named PRIMA System has been developed to help end-stage patients affected by AMD by partially restoring their sight. The feasibility study for PRIMA gave excellent preliminary results, making most of the participants in the study able to read letters and words. PRIMA will be tested for safety and efficacy also in RP patients, in order to see if similar results as in AMD patients can be obtained.

The study will be an open label, non-randomized feasibility study with 5 patients across two study sites (Tor Vergata University of Rome, Italy, and Fondation Adolphe de Rotschild Hospital, Paris, France). Recruiting period will be 1 year and the implanted patients will be followed up for 3 years, with performance endpoints measured 12 months after implantation. Subjects participating in this study will follow a visual training program that will be focused on the subject’s specific needs (e.g. reading, mobility, etc.) and they will be asked to use PRIMA at home, in order to explore the potential to improve daily life tasks.

A sensibilization informational campaign for the potentialities of PRIMA in AMD and RP patients and their families has already been started by the Macula & Genoma Foundation in occasion of its annual meeting “Macula Today”, and further sensibilization campaign will be needed to give AMD and RP patients exact information and expectations for the next-to-come treatment options.