Retinitis PigmentosaNRNCT04295304
NR600 System Retinal Prosthesis for Patients With Retinal Degenerative Diseases
A study testing Retinal surgery with implantation of epi-retinal device in people with Retinitis Pigmentosa and Retinal Degeneration, run by Nano Retina at 6 sites in 3 countries.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Retinitis Pigmentosa, Retinal Degeneration
- What is being tested?
- Retinal surgery with implantation of epi-retinal device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 17 Jan 2020to 12 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
About this study
Official title: 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
Read the 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.
- Conditions
- Retinitis Pigmentosa, Retinal Degeneration
- Being tested
- Retinal surgery with implantation of epi-retinal device
- Medical subject headings
- Retinitis Pigmentosa, Retinal Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinal surgery with implantation of epi-retinal deviceDevice
Retinal surgery and implantation of epi-retinal prosthesis
| Study group | Role | What they receive |
|---|---|---|
| NR600 device implantation | Experimental | Retinal surgery and implantation of epi-retinal prosthesis Receives: Device: Retinal surgery with implantation of epi-retinal device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoint
Occurrence of serious adverse events related to the device and/or to the procedure
Measured: within 9 months post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start17 Jan 2020
- Primary completion9 Mar 2023
- Study completion12 Mar 2023
Why it stopped: Lack of funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nano Retina
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedPass International
- Responsible party
- Sponsor
- Investigators
- Weinberger Dov, Prof., Study chair, Retinal surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295304
- Sponsor's protocol ID
- NR-DOC-14670
- Acronym
- NR
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2020
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Evaluation of the NR600 System in Subjects With End-stage Inherited Outer Retinal Degenerative Diseases
- ClinicalTrials.gov ID
- NCT04295304
- Acronym / sponsor ID
- NR / NR-DOC-14670
- Conditions
- Retinitis Pigmentosa, Retinal Degeneration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funds
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Nano RetinaIndustry (pharma, biotech, devices)
- Collaborators
- MedPass International
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 12 Mar 2023 (actual)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NR600 device implantation | Experimental | Device: Retinal surgery with implantation of epi-retinal deviceRetinal surgery and implantation of epi-retinal prosthesis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retinal surgery with implantation of epi-retinal deviceRetinal surgery and implantation of epi-retinal prosthesis | Device | NR600 device implantation |
Primary outcome
Safety endpoint
Time frame: within 9 months post implantation
Occurrence of serious adverse events related to the device and/or to the procedure
Results and safety
The study was stopped early (reason given: Lack of funds). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weinberger Dov, Prof. study chair
Retinal surgeon
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retinal surgery with implantation of epi-retinal device in people with Retinitis Pigmentosa and Retinal Degeneration, run by Nano Retina at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, Israel, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of funds). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety endpoint (time frame: within 9 months post implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.