Compensation for Blindness With the Intelligent Retinal Implant System (IRIS V2) in Patients With Retinal Dystrophy (IRIS 2)

• Sponsor: Pixium Vision SA
• Information provided by (Responsible Party): Pixium Vision SA

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.

Condition or disease	Intervention/treatment	Phase
Retinitis Pigmentosa; Cone Rod Dystrophy; Choroideremia	Device: Intelligent Retinal Implant System	Not Applicable

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	10 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Compensation for Blindness With the Intelligent Retinal Implant System (IRIS V2) in Patients With Retinal Dystrophy
Study Start Date :	January 2016
Actual Primary Completion Date :	May 2019
Actual Study Completion Date :	May 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Retina Implant; Intelligent Retinal Implant System	Device: Intelligent Retinal Implant System

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Visual acuity [ Time Frame: up to 36 month ]
   Measure probable benefit with square wave grating test
2. Square localization [ Time Frame: up to 36 month ]
   Measure probable by measuring the error in localizing a white square on black background.
3. Functional Vision [ Time Frame: up to 36 month ]
   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.

Eligibility Criteria

Layout table for eligibility information

Ages Eligible for Study:	25 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Locations

Layout table for location information

Austria
Medical University of Graz
Graz, Austria, 8036
France
Clinique Ophtalmologique du CHU de Nantes
Nantes, France, 44000
CHU Nimes, Service Ophtalmologie (France)/ Hopital Gui de Chauliac, CHU Montpelier, (France)
Nimes, France, 30029
Hopital des Quinze Vingts/Fondation Ophtalmologique A. De Rothschild
Paris, France, 75012
Germany
Dept. of Ophthalmology, University of Bonn
Bonn, Germany, 53127
Universitäts KlinikumKlinik für Augenheilkunde Freiburg
Freiburg, Germany, 79106
Klinik und Poliklinik für Augenheilkunde Hamburg -Eppendorf
Hamburg, Germany, 20246
Spain
Instituto de Microcirugia Ocular
Barcelona, Spain, 08035
United Kingdom
Moorfields Eye Hospital
London, United Kingdom

Sponsors and Collaborators

Pixium Vision SA

More Information

Layout table for additonal information

Responsible Party:	Pixium Vision SA
ClinicalTrials.gov Identifier:	NCT02670980 History of Changes
Other Study ID Numbers:	CPP1
First Posted:	February 2, 2016
Last Update Posted:	May 29, 2019
Last Verified:	May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Pixium Vision SA:

Retina Implant; Visual Prosthesis

Additional relevant MeSH terms:

Layout table for MeSH terms

Retinitis; Retinitis Pigmentosa; Blindness; Retinal Dystrophies; Choroideremia; Cone-Rod Dystrophies; Retinal Diseases; Eye Diseases; Eye Diseases, Hereditary; Retinal Degeneration	Genetic Diseases, Inborn; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Choroid Diseases; Uveal Diseases; Genetic Diseases, X-Linked