Clinical trial NCT00407602: Argus® II Retinal Stimulation System Feasibility Protocol
Official title: Argus® II Retinal Stimulation System Feasibility Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinitis Pigmentosa
Keywords: retinitis pigmentosa
device
retinal implant
retinal prosthesis
RP
outer retinal degeneration
Lead sponsor: Second Sight Medical Products
Sponsor class: INDUSTRY
Collaborators: name: National Eye Institute (NEI)
First posted: 2006-12-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigational Phase of the Study:

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 retinitis pigmentosa.

Post-Approval Phase of the Study:

To collect post-approval data in order to monitor the ongoing safety and reliability of the Argus II System

Detailed description: During the post-approval phase, subjects will undergo annual eye exams, assessments of medical status and adverse events, and measurement of stimulation thresholds. In addition, at the mutual agreement of the investigator and the subject, subjects will have the option of participating in psychophysical research which could occur as frequently as monthly. Functional tests at 10 years: photographic flash, square localization, direction of motion and grating visual acuity.

Eligibility criteria: 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)

Primary outcomes:
measure: Visual Acuity
timeFrame: 10 years
measure: Number of Participants With Adverse Events
timeFrame: 10 years
Secondary outcomes:
measure: Massof Activity Inventory
timeFrame: 3 years
measure: Quality of Life - Tasks for Daily Living
timeFrame: 3 years
measure: Orientation and Mobility
timeFrame: 5 years
measure: Visual Function
timeFrame: 10 years
measure: Stability of Implant - 5 Years Post Implant
timeFrame: 5 years
measure: Device Reliability
timeFrame: 10 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Doheny Eye Institute
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Baltimore
country: United States
facility: Johns Hopkins, Wilmer Eye Institute
state: Maryland
city: New York
country: United States
facility: Columbia University, Department of Ophthalmology, Edward S. Harkness Eye Institute
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania, Scheie Eye Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
city: Paris
country: France
facility: Centre d'Investigation Clinique, Service d'Ophtalmologie, Quinze-Vingts National Eye Hospital, 28 rue de Charenton, 75557 Cedex 12
city: Zapopan
country: Mexico
facility: Puerta de Hierro, Centro Medico, Centro de Retina
state: Jalisco
city: Geneva
country: Switzerland
facility: Clinique d'Ophthalmologie Hopitaux, Universitaires de Geneve 22 rue Alcide Jentzer 1205
city: London
country: United Kingdom
facility: Moorfields Eye Hospital, Vitreoretinal Research Unit
city: Manchester
country: United Kingdom
facility: Manchester Royal Eye Hospital
Study officials:
affiliation: Second Sight Medical Products
name: Anne-Marie Ripley
role: STUDY_DIRECTOR
References:
citation: Weiland JD, Faraji B, Greenberg RJ, Humayun MS, Shellock FG. Assessment of MRI issues for the Argus II retinal prosthesis. Magn Reson Imaging. 2012 Apr;30(3):382-9. doi: 10.1016/j.mri.2011.12.005. Epub 2012 Jan 20.
citation: Humayun MS, Dorn JD, da Cruz L, Dagnelie G, Sahel JA, Stanga PE, Cideciyan AV, Duncan JL, Eliott D, Filley E, Ho AC, Santos A, Safran AB, Arditi A, Del Priore LV, Greenberg RJ; Argus II Study Group. Interim results from the international trial of Second Sight's visual prosthesis. Ophthalmology. 2012 Apr;119(4):779-88. doi: 10.1016/j.ophtha.2011.09.028. Epub 2012 Jan 11.
citation: Barry MP, Dagnelie G; Argus II Study Group. Use of the Argus II retinal prosthesis to improve visual guidance of fine hand movements. Invest Ophthalmol Vis Sci. 2012 Aug 1;53(9):5095-101. doi: 10.1167/iovs.12-9536.
citation: Ahuja AK, Dorn JD, Caspi A, McMahon MJ, Dagnelie G, Dacruz L, Stanga P, Humayun MS, Greenberg RJ; Argus II Study Group. Blind subjects implanted with the Argus II retinal prosthesis are able to improve performance in a spatial-motor task. Br J Ophthalmol. 2011 Apr;95(4):539-43. doi: 10.1136/bjo.2010.179622. Epub 2010 Sep 29.
citation: Arevalo JF, Al Rashaed S, Alhamad TA, Al Kahtani E, Al-Dhibi HA; KKESH Collaborative Retina Study Group. Argus II retinal prosthesis for retinitis pigmentosa in the Middle East: The 2015 Pan-American Association of Ophthalmology Gradle Lecture. Int J Retina Vitreous. 2021 Oct 27;7(1):65. doi: 10.1186/s40942-021-00324-6.
citation: Sabbah N, Authie CN, Sanda N, Mohand-Said S, Sahel JA, Safran AB. Importance of eye position on spatial localization in blind subjects wearing an Argus II retinal prosthesis. Invest Ophthalmol Vis Sci. 2014 Nov 20;55(12):8259-66. doi: 10.1167/iovs.14-15392.
citation: Ahuja AK, Yeoh J, Dorn JD, Caspi A, Wuyyuru V, McMahon MJ, Humayun MS, Greenberg RJ, Dacruz L. Factors Affecting Perceptual Threshold in Argus II Retinal Prosthesis Subjects. Transl Vis Sci Technol. 2013 Apr;2(4):1. doi: 10.1167/tvst.2.4.1. Epub 2013 Apr 12.
citation: de Juan E Jr, Spencer R, Barale PO, da Cruz L, Neysmith J. Extraction of retinal tacks from subjects implanted with an epiretinal visual prosthesis. Graefes Arch Clin Exp Ophthalmol. 2013 Oct;251(10):2471-6. doi: 10.1007/s00417-013-2452-y. Epub 2013 Sep 8.
citation: Stronks HC, Barry MP, Dagnelie G. Electrically elicited visual evoked potentials in Argus II retinal implant wearers. Invest Ophthalmol Vis Sci. 2013 Jun 6;54(6):3891-901. doi: 10.1167/iovs.13-11594.
citation: Dorn JD, Ahuja AK, Caspi A, da Cruz L, Dagnelie G, Sahel JA, Greenberg RJ, McMahon MJ; gus II Study Group. The Detection of Motion by Blind Subjects With the Epiretinal 60-Electrode (Argus II) Retinal Prosthesis. JAMA Ophthalmol. 2013 Feb;131(2):183-9. doi: 10.1001/2013.jamaophthalmol.221.
citation: Ahuja AK, Behrend MR. The Argus II retinal prosthesis: factors affecting patient selection for implantation. Prog Retin Eye Res. 2013 Sep;36:1-23. doi: 10.1016/j.preteyeres.2013.01.002. Epub 2013 Mar 14.
citation: Olson JL, Velez-Montoya R, Mandava N, Stoldt CR. Intravitreal silicon-based quantum dots as neuroprotective factors in a model of retinal photoreceptor degeneration. Invest Ophthalmol Vis Sci. 2012 Aug 17;53(9):5713-21. doi: 10.1167/iovs.12-9745.
citation: Perez Fornos A, Sommerhalder J, da Cruz L, Sahel JA, Mohand-Said S, Hafezi F, Pelizzone M. Temporal properties of visual perception on electrical stimulation of the retina. Invest Ophthalmol Vis Sci. 2012 May 4;53(6):2720-31. doi: 10.1167/iovs.11-9344.