Retinitis PigmentosaIRIS 2NCT02670980
Compensation for Blindness With the Intelligent Retinal Implant System (IRIS V2) in Patients With Retinal Dystrophy
A study testing Intelligent Retinal Implant System in people with Retinitis Pigmentosa and Cone Rod Dystrophy, run by Science Corporation at 9 sites in 5 countries.
Trial summary
This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System (IRIS V2). Blind patient suffering from Retinitis Pigmentosa, Cone Rod Dystrophy, or Choroideremia are implanted with an Intelligent Retinal Implant Systeme. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Retinitis Pigmentosa, Cone Rod Dystrophy, Choroideremia
- What is being tested?
- Intelligent Retinal Implant System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Jan 2016to May 2019
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is 25 years or older at the date of enrolment
- Has a confirmed diagnosis of retinitis pigmentosa, choroideremia or cone-rod dystrophy
- Has a visual acuity of logMAR 2.3 or worse in both the eyes as determined by a Square Grating scale.
- Has functional ganglion cells and optic nerve activity
- Has a memory of former useful form vision
- Understands and accepts the obligation to present for all schedule follow-up visits.
Who cannot join
- Has a history of severe glaucoma, uveitis, optic neuropathy or any confirmed damage to the optic nerve and/or visual cortex related to the projected implanted eye,
- Has any disease (other than study allowed diseases) or condition that affects retinal function of the study eye (e.g., central retinal artery/vein occlusion, end-stage diabetic retinopathy, current or prior retinal detachment, infectious or inflammatory retinal disease, etc.),
- Has any disease or condition that prevents adequate visualization of the retina of the study eye including, but not limited to, corneal degeneration that cannot be resolved prior to implantation,
- Has any disease or condition of the anterior segment of the study eye that prevents adequate physical examination (e.g., ocular trauma, etc.),
- Has severe nystagmus,
- Has any ocular condition that leads him or her to eye rubbing,
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- Has any disease or condition that precludes the understanding or communication of the informed consent, study requirements or test protocols (e.g., deafness , multiple sclerosis, amyotrophic lateral sclerosis, neuritis, etc),
- Has a history of epileptic seizure,
- Has a history of chronic or recurrent infection or inflammation that would preclude participation in the study,
- Has a known sensitivity to the contact materials of the implant (platinum and parylene),
- Presents with hypotony in the study eye,
- Presents with hypertony in the study eye,
- Is pregnant or lactating,
- Has another active implanted device (e.g. cochlear implant) or any form of metallic implant in the head (other than dental work) that may interfere with the device function,
- Has a diagnosis requiring an active implant (e.g., cardiac pacemaker, vagus nerve implant, etc.),
- Has active cancer or a history of intraocular, optic nerve or brain cancer and metastasis,
- Is an immune-suppressed subject (e.g., due to HIV positive diagnosis, etc.),
- Is carrier of multi-resistant germs,
- Requires the use of any of the following medications:
- Antimetabolites,
- Thrombocyte aggregation reducing therapies (10 days prior until 3 days after surgery),
- Oral anticoagulants (5 days before until 3 days after surgery),
- Is participating in another investigational drug or device study,
- Has any health concern that makes general anaesthesia inadvisable; Patients with an ASA-Score (or equivalent) of 3 or higher are excluded from the study,
- Is likely requiring MRI scans subsequent to implantation and prior to explantation,
- Is likely requiring therapeutic ultrasound subsequent to implantation and prior to explantation of the Retinal Implant.
- Patients with recurrent or chronic inflammations or infections are excluded from the study. Specifically patients with the following disorders are excluded:
- Common inflammation - severe chronic and consuming diseases that frequently associated with infection (e.g. Crohn disease, Whipple's disease)
- Chronic inflammation of the skin in the area of the eye (e.g. dermatitis, rosacea, infection of the skin, herpes zoster)
- Chronic inflammation in the area of the eye (e.g. herpes of cornea and/or conjunctiva, recurrent blepharoconjunctivitis, hordeolum, chalazion)
- Has a severe psychological disorder. When in any doubt, an expert assessment needs to be arranged to clarify whether the patient's psychological health is suitable for the trial.
- Has severe renal, cardiac, hepatic etc. organ diseases.
- Has eye AP dimension that are incompatible (less than 20.5 or larger than 25mm) with the implant or head dimension that are incompatible with the Visual Interface. Please make sure that the size of the eye socket allows an implantation of the extra ocular part which has a thickness of 5mm.
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
France3 sites
Clinique Ophtalmologique du CHU de Nantes
Nantes, 44000
CHU Nimes, Service Ophtalmologie (France)/ Hopital Gui de Chauliac, CHU Montpelier, (France)
Nîmes, 30029
Hopital des Quinze Vingts/Fondation Ophtalmologique A. De Rothschild
Paris, 75012
Germany3 sites
Dept. of Ophthalmology, University of Bonn
Bonn, 53127
Universitäts KlinikumKlinik für Augenheilkunde Freiburg
Freiburg im Breisgau, 79106
Klinik und Poliklinik für Augenheilkunde Hamburg -Eppendorf
Hamburg, 20246
About this study
This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System (IRIS V2). Blind patient suffering from Retinitis Pigmentosa, Cone Rod Dystrophy, or Choroideremia are implanted with an Intelligent Retinal Implant Systeme. All subjects undergo ophthalmological examinations in predefined intervals after implantation. Ophthalmological examinations include funduscopy, slit lamp examination and OCT. All adverse events are recorded and analyzed. Efficacy is measured using functional vision and visual function tests before and after implantation as well as with the system on and system off.
- Conditions
- Retinitis Pigmentosa, Cone Rod Dystrophy, Choroideremia
- Being tested
- Intelligent Retinal Implant System
- Keywords
- Retina Implant, Visual Prosthesis
- Medical subject headings
- Retinitis Pigmentosa, Cone-Rod Dystrophies, Choroideremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent Retinal Implant SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Retina Implant | Experimental | Intelligent Retinal Implant System Receives: Device: Intelligent Retinal Implant System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events according to ISO14155
All subjects undergo ophthalmological examinations in predefined intervals after implantation. Adverse event are rated to be serious or non-serious according ISO14155
Measured: up to 36 month
Secondary outcomes (3)
Visual acuity
Measure probable benefit with square wave grating test
Measured: up to 36 month
Square localization
Measure probable by measuring the error in localizing a white square on black background.
Measured: up to 36 month
Functional Vision
Measure probable benefit e.g. by Functional Picture Assessment. The number of errors subjects make in detecting objects or persons on standardized pictures is measures. Other test may be developed during the study.
Measured: up to 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2019
- Study completionMay 2019
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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670980
- Sponsor's protocol ID
- CPP1
- Acronym
- IRIS 2
- Status last verified
- May 2019
- First submitted
- 4 Jan 2016
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compensation for Blindness With the Intelligent Retinal Implant System (IRIS V2) in Patients With Retinal Dystrophy
- ClinicalTrials.gov ID
- NCT02670980
- Acronym / sponsor ID
- IRIS 2 / CPP1
- Conditions
- Retinitis Pigmentosa, Cone Rod Dystrophy, Choroideremia
- Keywords
- Retina Implant, Visual Prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Science CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- May 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 2 Feb 2016 (estimated)
- 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.
This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System (IRIS V2). Blind patient suffering from Retinitis Pigmentosa, Cone Rod Dystrophy, or Choroideremia are implanted with an Intelligent Retinal Implant Systeme. All subjects undergo ophthalmological examinations in predefined intervals after implantation. Ophthalmological examinations include funduscopy, slit lamp examination and OCT. All adverse events are recorded and analyzed. Efficacy is measured using functional vision and visual function tests before and after implantation as well as with the system on and system off.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retina Implant | Experimental | Device: Intelligent Retinal Implant SystemIntelligent Retinal Implant System |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Is 25 years or older at the date of enrolment
- Has a confirmed diagnosis of retinitis pigmentosa, choroideremia or cone-rod dystrophy
- Has a visual acuity of logMAR 2.3 or worse in both the eyes as determined by a Square Grating scale.
- Has functional ganglion cells and optic nerve activity
- Has a memory of former useful form vision
Key exclusion criteria (33 listed)
- Has a history of severe glaucoma, uveitis, optic neuropathy or any confirmed damage to the optic nerve and/or visual cortex related to the projected implanted eye,
- Has any disease (other than study allowed diseases) or condition that affects retinal function of the study eye (e.g., central retinal artery/vein occlusion, end-stage diabetic retinopathy, current or prior retinal detachment, infectious or inflammatory retinal disease, etc.),
- Has any disease or condition that prevents adequate visualization of the retina of the study eye including, but not limited to, corneal degeneration that cannot be resolved prior to implantation,
- Has any disease or condition of the anterior segment of the study eye that prevents adequate physical examination (e.g., ocular trauma, etc.),
- Has severe nystagmus,
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 |
|---|---|---|
| Intelligent Retinal Implant System | Device | Retina Implant |
Primary outcome
Number of participants with treatment-related adverse events according to ISO14155
Time frame: up to 36 month
All subjects undergo ophthalmological examinations in predefined intervals after implantation. Adverse event are rated to be serious or non-serious according ISO14155
3 secondary outcomes
Visual acuity
Time frame: up to 36 month
Square localization
Time frame: up to 36 month
Functional Vision
Time frame: up to 36 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intelligent Retinal Implant System in people with Retinitis Pigmentosa and Cone Rod Dystrophy, run by Science Corporation at 9 sites in 5 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 6 inclusion and 33 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: finished, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, Germany, Austria, Spain, United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with treatment-related adverse events according to ISO14155 (time frame: up to 36 month). 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 29 May 2019.