NR600 System Retinal Prosthesis for Patients With Retinal Degenerative Diseases (NR)

March 13, 2023 updated by: Nano Retina

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

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

Study Overview

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 Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Ghent, Belgium
        • UZ Ghent
      • Leuven, Belgium
        • UZ Leuven
      • Petach Tikva, Israel
        • Rabin Medical Center
      • Tel AViv, Israel
        • Sourasky Medical Center
      • Milan, Italy
        • San Raffaele
      • Rome, Italy
        • Fondazione Policlinico A. Gemelli, IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NR600 device implantation
Retinal surgery and implantation of epi-retinal prosthesis
Retinal surgery and implantation of epi-retinal prosthesis

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2020

Primary Completion (Actual)

March 9, 2023

Study Completion (Actual)

March 12, 2023

Study Registration Dates

First Submitted

March 2, 2020

First Submitted That Met QC Criteria

March 3, 2020

First Posted (Actual)

March 4, 2020

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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