Overview

This trial is active, not recruiting.

Condition retinitis pigmentosa
Treatment argus ii retinal stimulation system
Phase phase 2
Sponsor Second Sight Medical Products
Collaborator National Eye Institute (NEI)
Start date September 2006
End date March 2012
Trial size 30 participants
Trial identifier NCT00407602, CP-003-001, National Eye Institute (NEI)

Summary

The objective of this feasibility study is to evaluate the safety and utility of the Argus II Retinal Stimulation System in providing visual function to blind subjects with severe to profound retinitis pigmentosa.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
This is a single group study where the status and performance of the implanted eye prior to surgery serves as the comparator.
argus ii retinal stimulation system
epiretinal implantation of device

Primary Outcomes

Measure
Visual acuity
time frame: 5 years
Safety
time frame: 5 years

Secondary Outcomes

Measure
Activities of daily living
time frame: 5 years
Quality of life
time frame: 5 years
Orientation and Mobility
time frame: 5 years
Spatial Vision
time frame: 5 years
Stability of Implant
time frame: 5 years
System Functionality
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - A confirmed history of retinitis pigmentosa (all centers) or outer retinal degeneration (France, U.K., Switzerland, Mexico only) with remaining visual acuity of bare light perception (all centers) or 2.3 logMAR (France, U.K., Switzerland, Mexico only) or worse in both eyes. - Functional ganglion cells and optic nerve as determined by a measurable electrically evoked response or documented light perception. - A history of former useful form vision in the worse-seeing eye. - Must be at least the following age at the time of enrollment: 25 (USA, Switzerland) or 18 (France, U.K., and Mexico) years old - Must reside within 2 hours (USA, UK and Mexico) or 3 hours (France and Switzerland) distance (by ground transportation) of the investigational site. - Must be willing and able to comply with the protocol testing and follow-up requirements. Exclusion Criteria: - Optic Nerve disease - History of glaucoma - Optic neuropathy or other confirmed damage to optic nerve or visual cortex damage - Diseases or conditions that effect retinal function including but not limited to: - Central retinal artery/vein occlusion (CRAO or CRVO) - End-stage diabetic retinopathy - Retinal detachment or history of retinal detachment - Trauma - Infectious or inflammatory retinal diseases - Diseases or conditions that prevent adequate visualization of the retina including, but not limited to corneal degeneration that cannot be resolved before implant. - Diseases or conditions of the anterior segment that prevent the ability to adequately perform the physical examination including but not limited to trauma or lid malpositions. - Diseases of the ocular surface including but not limited to keratitis sicca. - An ocular condition that predisposes the subject to eye rubbing. - Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including: - Cognitive decline including diagnosed forms of dementia and/or progressive neurological disease - Psychiatric Disease including diagnosed forms of depression - Does not speak a principal language associated with the region - Deafness or selective frequency hearing loss that prevents hearing device alarms and alerts. - Pregnancy - Subject has another active implantable device (e.g. cochlear implant), or any form of metallic implant in the head - Conjunctival thinning which may predispose the subject to conjunctival erosion in the area where the implant will be installed extra-ocularly. - Subject is participating in another investigational drug or device study that may conflict with the objectives, follow-up or testing of this study - Any health concern that makes general anesthesia inadvisable. - Subject has unrealistic expectations of the implant. - Known allergy or contraindication to anticipated pre-operative, intra-operative or post-operative medications. - Conditions likely to limit life to less than 1 year from the time of screening. - Diseases or conditions that, in the judgement of the surgeon, impede the ability to implant the device or would prevent the system from functioning for the duration of the study (e.g. strabismus) - Axial eye length <21.5 mm or >26.0 mm in the implanted eye as measured by ultrasound (US only)

Additional Information

Official title Argus® II Retinal Stimulation System Feasibility Protocol
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Second Sight Medical Products.