NCT04295304

NR600 System Retinal Prosthesis for Patients With Retinal Degenerative Diseases

Safety and Performance Evaluation of the NR600 System in Subjects With End-stage Inherited Outer Retinal Degenerative Diseases

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Nano Retina · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study objective is to demonstrate safety of the NR 600 System, and to evaluate the performance of the device in restoring visual activity of daily living in subjects with retinal degenerative diseases and severe visual impairment

Detailed description

The NR600 is a retinal prosthetic system intended to provide electrical stimulation to the retina to induce visual perception in patients with severe to profound vision loss due to degenerative retinal disease. The system is consisting of an autonomous epiretinal implant with penetrating electrodes, Glasses and a Clinician Station. The implant is Infrared (IR) powered and is designed to convert visual input into well-defined electrical stimulation patterns suited to elicit neuronal retina activity. All study subjects will be implanted with the device in one eye and will be followed for 18-months.

Conditions

• Retinitis Pigmentosa
• Retinal Degeneration

Interventions

Type	Name	Description
DEVICE	Retinal surgery with implantation of epi-retinal device	Retinal surgery and implantation of epi-retinal prosthesis

Timeline

• Start date: 2020-01-17
• Primary completion: 2023-03-09
• Completion: 2023-03-12
• First posted: 2020-03-04
• Last updated: 2023-03-15

Locations

6 sites across 3 countries: Belgium, Israel, Italy