Compensation for Blindness With the Intelligent Retinal Implant System (IRIS V2) in Patients With Retinal Dystrophy (IRIS 2)
Primary Purpose
Retinitis Pigmentosa, Cone Rod Dystrophy, Choroideremia
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Intelligent Retinal Implant System
Sponsored by
About this trial
This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring Retina Implant, Visual Prosthesis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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,
- 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.
Sites / Locations
- Medical University of Graz
- Clinique Ophtalmologique du CHU de Nantes
- CHU Nimes, Service Ophtalmologie (France)/ Hopital Gui de Chauliac, CHU Montpelier, (France)
- Hopital des Quinze Vingts/Fondation Ophtalmologique A. De Rothschild
- Dept. of Ophthalmology, University of Bonn
- Universitäts KlinikumKlinik für Augenheilkunde Freiburg
- Klinik und Poliklinik für Augenheilkunde Hamburg -Eppendorf
- Instituto de Microcirugia Ocular
- Moorfields Eye Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Retina Implant
Arm Description
Intelligent Retinal Implant System
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Visual acuity
Measure probable benefit with square wave grating test
Square localization
Measure probable by measuring the error in localizing a white square on black background.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02670980
Brief Title
Compensation for Blindness With the Intelligent Retinal Implant System (IRIS V2) in Patients With Retinal Dystrophy
Acronym
IRIS 2
Official Title
Compensation for Blindness With the Intelligent Retinal Implant System (IRIS V2) in Patients With Retinal Dystrophy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pixium Vision SA
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa, Cone Rod Dystrophy, Choroideremia
Keywords
Retina Implant, Visual Prosthesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Retina Implant
Arm Type
Experimental
Arm Description
Intelligent Retinal Implant System
Intervention Type
Device
Intervention Name(s)
Intelligent Retinal Implant System
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events according to ISO14155
Description
All subjects undergo ophthalmological examinations in predefined intervals after implantation. Adverse event are rated to be serious or non-serious according ISO14155
Time Frame
up to 36 month
Secondary Outcome Measure Information:
Title
Visual acuity
Description
Measure probable benefit with square wave grating test
Time Frame
up to 36 month
Title
Square localization
Description
Measure probable by measuring the error in localizing a white square on black background.
Time Frame
up to 36 month
Title
Functional Vision
Description
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.
Time Frame
up to 36 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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,
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.
Facility Information:
Facility Name
Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Clinique Ophtalmologique du CHU de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
CHU Nimes, Service Ophtalmologie (France)/ Hopital Gui de Chauliac, CHU Montpelier, (France)
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Hopital des Quinze Vingts/Fondation Ophtalmologique A. De Rothschild
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Dept. of Ophthalmology, University of Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitäts KlinikumKlinik für Augenheilkunde Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Klinik und Poliklinik für Augenheilkunde Hamburg -Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Instituto de Microcirugia Ocular
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Moorfields Eye Hospital
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Compensation for Blindness With the Intelligent Retinal Implant System (IRIS V2) in Patients With Retinal Dystrophy
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