NR600 System Retinal Prosthesis for Patients With Retinal Degenerative Diseases

Retinitis Pigmentosa Clinical Trial

— NR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04295304
• Other study ID #: NR-DOC-14670
• Status: Terminated
• Phase: N/A
• Start date: January 17, 2020
• Est. completion date: March 12, 2023

Study information

• Verified date: March 2023
• Source: Nano Retina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: March 12, 2023
• Est. primary completion date: March 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Retinal Degeneration
• Retinitis
• Retinitis Pigmentosa

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Nano Retina	MedPass International

Countries where clinical trial is conducted

Belgium,  Israel,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety endpoint	Occurrence of serious adverse events related to the device and/or to the procedure	within 9 months post implantation