Clinical trial NCT04295304: NR600 System Retinal Prosthesis for Patients With Retinal Degenerative Diseases
Official title: Safety and Performance Evaluation of the NR600 System in Subjects With End-stage Inherited Outer Retinal Degenerative Diseases
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Retinitis Pigmentosa
Retinal Degeneration
Lead sponsor: Nano Retina
Sponsor class: INDUSTRY
Collaborators: name: MedPass International
First posted: 2020-03-04
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety endpoint
timeFrame: within 9 months post implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: UZ Ghent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Tel AViv
country: Israel
facility: Sourasky Medical Center
city: Milan
country: Italy
facility: San Raffaele
city: Rome
country: Italy
facility: Fondazione Policlinico A. Gemelli, IRCCS
Study officials:
affiliation: Retinal surgeon
name: Weinberger Dov, Prof.
role: STUDY_CHAIR
References: