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

Primary Purpose

Retinitis Pigmentosa, Retinal Degeneration

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Retinal surgery with implantation of epi-retinal device
Sponsored by
Nano Retina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UZ Ghent
  • UZ Leuven
  • Rabin Medical Center
  • Sourasky Medical Center
  • San Raffaele
  • Fondazione Policlinico A. Gemelli, IRCCS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NR600 device implantation

Arm Description

Retinal surgery and implantation of epi-retinal prosthesis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 2, 2020
Last Updated
March 13, 2023
Sponsor
Nano Retina
Collaborators
MedPass International
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1. Study Identification

Unique Protocol Identification Number
NCT04295304
Brief Title
NR600 System Retinal Prosthesis for Patients With Retinal Degenerative Diseases
Acronym
NR
Official Title
Safety and Performance Evaluation of the NR600 System in Subjects With End-stage Inherited Outer Retinal Degenerative Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Lack of funds
Study Start Date
January 17, 2020 (Actual)
Primary Completion Date
March 9, 2023 (Actual)
Study Completion Date
March 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nano Retina
Collaborators
MedPass International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa, Retinal Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NR600 device implantation
Arm Type
Experimental
Arm Description
Retinal surgery and implantation of epi-retinal prosthesis
Intervention Type
Device
Intervention Name(s)
Retinal surgery with implantation of epi-retinal device
Intervention Description
Retinal surgery and implantation of epi-retinal prosthesis
Primary Outcome Measure Information:
Title
Safety endpoint
Description
Occurrence of serious adverse events related to the device and/or to the procedure
Time Frame
within 9 months post implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weinberger Dov, Prof.
Organizational Affiliation
Retinal surgeon
Official's Role
Study Chair
Facility Information:
Facility Name
UZ Ghent
City
Ghent
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
Country
Belgium
Facility Name
Rabin Medical Center
City
Petach Tikva
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel AViv
Country
Israel
Facility Name
San Raffaele
City
Milan
Country
Italy
Facility Name
Fondazione Policlinico A. Gemelli, IRCCS
City
Rome
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

NR600 System Retinal Prosthesis for Patients With Retinal Degenerative Diseases

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