NR600 System Retinal Prosthesis for Patients With Retinal Degenerative Diseases

Nano Retina (Industry)
Overall Status
Recruiting ID
MedPass International (Industry)

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Device: Retinal surgery with implantation of epi-retinal device

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.

Study Design

Study Type:
Anticipated Enrollment :
35 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Safety and Performance Evaluation of the NR600 System in Subjects With End-stage Inherited Outer Retinal Degenerative Diseases
Actual Study Start Date :
Jan 17, 2020
Anticipated Primary Completion Date :
Jan 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: NR600 device implantation

Retinal surgery and implantation of epi-retinal prosthesis

Device: Retinal surgery with implantation of epi-retinal device
Retinal surgery and implantation of epi-retinal prosthesis

Outcome Measures

Primary Outcome Measures

  1. Safety endpoint [within 9 months post implantation]

    Occurrence of serious adverse events related to the device and/or to the procedure

Eligibility Criteria


Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Accepts 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

Contacts and Locations


Site City State Country Postal Code
1 UZ Ghent Ghent Belgium
2 UZ Leuven Leuven Belgium
3 Rabin Medical Center Petach Tikva Israel
4 Sourasky Medical Center Tel AViv Israel
5 San Raffaele Milan Italy
6 Fondazione Policlinico A. Gemelli, IRCCS Rome Italy

Sponsors and Collaborators

  • Nano Retina
  • MedPass International


  • Study Chair: Weinberger Dov, Prof., Retinal surgeon

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Nano Retina Identifier:
Other Study ID Numbers:
  • NR-DOC-14670
First Posted:
Mar 4, 2020
Last Update Posted:
Jul 26, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 26, 2022