NR600 System Retinal Prosthesis for Patients With Retinal Degenerative Diseases

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Retinitis Pigmentosa, Retinal Degeneration

Intervention / Treatment
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* Device: Retinal surgery with implantation of epi-retinal device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have confirmed diagnosis of end-stage hereditary outer retinal degeneration such as RP or cone-rod dystrophy Visual acuity in both eyes from light perception to no light perception Confirmed functional ganglion cells and optic nerve in the implanted eye History of useful vision Mentally competent Exclusion Criteria: Diseases or condition that affect retinal and or optic nerve function Optic Nerve diseases Diseases or conditions that, in the judgement of the surgeon, impede the ability to implant the device or would prevent the system from functioning Dry eye Pre-disposition to eye rubbing Posterior pole severe staphyloma Strabismus superior to 10 prismatic diopter Severe nystagmus Corneal endothelium density < 1500 cells/mm2 Refractive error ≥±8 diopters spheric and 3.5 diopter cylindric Currently pregnant (female subject) or inadequate contraceptive treatment in female subjects <50 years of age. Hyperthyroidism or hypersensitivity to iodine Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression) Participation in another study with any investigational drug or device that may conflict with the objectives, follow-up or testing of this study Conditions likely to limit life to less than 1 year from time of recruitment to the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NR600 device implantation<br>Retinal surgery and implantation of epi-retinal prosthesis | Device: Retinal surgery with implantation of epi-retinal device<br>* Retinal surgery and implantation of epi-retinal prosthesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety endpoint | Occurrence of serious adverse events related to the device and/or to the procedure | within 9 months post implantation |