NR600 System Retinal Prosthesis for Patients With Retinal Degenerative Diseases

Nano Retina

Status: Terminated

Conditions: Retinal Degeneration; Retinitis Pigmentosa

Treatments: Device: Retinal surgery with implantation of epi-retinal device

Study type: Interventional

Funder types: Industry

Identifiers

NCT04295304

NR-DOC-14670

Details and patient eligibility

About

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

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

NR600 device implantation

Experimental group

Description:

Retinal surgery and implantation of epi-retinal prosthesis

Treatment:

Device: Retinal surgery with implantation of epi-retinal device