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Trial record 1 of 1 for:    Nano retina | Retinitis Pigmentosa | Belgium
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NR600 System Retinal Prosthesis for Patients With Retinal Degenerative Diseases (NR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04295304
Recruitment Status : Recruiting
First Posted : March 4, 2020
Last Update Posted : August 19, 2020
Sponsor:
Collaborator:
MedPass International
Information provided by (Responsible Party):
Nano Retina

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
Retinitis Pigmentosa Retinal Degeneration Device: Retinal surgery with implantation of epi-retinal device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Performance Evaluation of the NR600 System in Subjects With End-stage Inherited Outer Retinal Degenerative Diseases
Actual Study Start Date : January 17, 2020
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Safety endpoint [ Time Frame: within 9 months post implantation ]
    Occurrence of serious adverse events related to the device and/or to the procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04295304


Contacts
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Contact: Rigler +972747377640 dudur@nano-retina.com

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Belgium
Contact: Inge Vriens    + 32 16 34 22 29    ingeborg.vriens@uzleuven.be   
Principal Investigator: Peter Stalmans, Prof.         
Israel
Rabin Medical Center Not yet recruiting
Petach Tikva, Israel
Contact: Hila       eyeclinic@clalit.org.il   
Principal Investigator: Rita Ehrlich, Dr.         
Sourasky Medical Center Not yet recruiting
Tel AViv, Israel
Contact: Sagit Bachor       sagitba@tlvmc.gov.il   
Principal Investigator: Adiel Barak, Prof.         
Sub-Investigator: Shulamit Schwartz, Dr.         
Italy
San Raffaele Recruiting
Milan, Italy
Contact: Francesca Calcagno, Dr.    +39 0226436212    calcagno.francesca@hsr.it   
Principal Investigator: Francesco Bandello, Prof.         
Fondazione Policlinico A. Gemelli, IRCCS Not yet recruiting
Rome, Italy
Contact: Falsini Benedetto, Prof.         
Principal Investigator: Stanislao Rizzo, Prof.         
Sponsors and Collaborators
Nano Retina
MedPass International
Investigators
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Study Chair: Weinberger Dov, Prof. Retinal surgeon
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Responsible Party: Nano Retina
ClinicalTrials.gov Identifier: NCT04295304    
Other Study ID Numbers: NR-DOC-14670
First Posted: March 4, 2020    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Retinitis
Retinitis Pigmentosa
Retinal Degeneration
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Genetic Diseases, Inborn