Nano Retina is conducting a prospective, multi-site, single-arm interventional clinical study of its NR600 retina implant. The trial will enroll up to 20 subjects at sites in Europe and Israel. To qualify for the study, subjects must have a confirmed diagnosis of end-stage hereditary outer retinal degeneration such as Retinitis Pigmentosa (RP) or cone-rod dystrophy.
The results of this study will be the basis of a submission for CE Mark approval. The Company anticipates initiating a pivotal clinical trial in the U.S. in 2021.
The primary endpoint of the study is safety, and the secondary endpoint is visual performance at 6-months post-optimization. Study participants will be followed for 18-months post optimization of the implant.
Many of the world’s preeminent retinal specialists and surgeons are Clinical Investigators of the NR-600 study, including:
Professor Peter Stalmans of UZ Leuven in Leuven, Belgium
Professor Inge Joniau of UZ Ghent in Ghent, Belgium
Professor Francesco Bandello of San Raffaele in Milan, Italy
Professor Stanislao Rizzo of Gemelli in Rome, Italy
Professor Adiel Barak of Sourasky in Tel-Aviv, Israel
Dr. Rita Erliech of Rabin Medical Center in Petach-Tikva, Israel