Restoring Vision With the Intelligent Retinal Implant System (IRIS V1)in Patients With Retinal Dystrophy

NCT01864486 | Completed DMC

• 1 other identifier: CP4M
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 5

Brief Summary

This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System (IRIS V1)

Conditions

Retinitis Pigmentosa; Cone Rod Dystrophy; Choroideremia

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events as a Measure of Safety and Tolerability

  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 analysed.

  Up to 18 month after implantation

Secondary Outcomes (1)

• Probable benefit

  Up to 18 months after implantation

Study Arms (1)

Intelligent Retinal Implant System

EXPERIMENTAL

Device: Intelligent Retinal Implant System

Interventions

Intelligent Retinal Implant System DEVICE

Intelligent Retinal Implant System

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Has AP eye dimensions that are appropriate with the dimensions of the implant(In Germany: Has an AP eye dimension between 20.5 and 25 mm)
• Has head dimensions that are appropriate for visual Interface.

You may not qualify if:

• Has a history of severe glaucoma, uveitis, optic neuropathy or any confirmed damage to the optic nerve and/or visual cortex,
• 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, amyotrophc 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,
• 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.),

Sponsors & Collaborators

• Science Corporation: lead

Study Sites (5)

Medical University of Graz

Graz, 8036, Austria

Location

Clinique Ophtalmologique du CHU de Nantes

Nantes, 44000, France

Location

Hopital des Quinze Vingts/Fondation Ophtalmologique A. De Rothschild

Paris, 75012, France

Location

Dept. of Ophthalmology, University of Bonn

Bonn, 53127, Germany

Location

Klinik und Poliklinik für Augenheilkunde Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Retinitis Pigmentosa; Cone-Rod Dystrophies; Choroideremia

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Choroid Diseases; Uveal Diseases; Genetic Diseases, X-Linked

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: May 29, 2013
• Study Start: April 1, 2013
• Primary Completion: October 13, 2017
• Study Completion: October 13, 2017
• Last Updated: October 17, 2017

Record last verified: 2017-10

Locations

FR (2); DE (2); AU (1)