Argus® II Retinal Stimulation System Feasibility Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00407602
Recruitment Status : Active, not recruiting
First Posted : December 5, 2006
Last Update Posted : May 29, 2015
National Eye Institute (NEI)
Information provided by (Responsible Party):
Second Sight Medical Products

December 1, 2006
December 5, 2006
May 29, 2015
September 2006
March 2012   (Final data collection date for primary outcome measure)
  • Visual acuity [ Time Frame: 5 years ]
  • Safety [ Time Frame: 5 years ]
  • Visual acuity
  • Safety
Complete list of historical versions of study NCT00407602 on Archive Site
  • 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 ]
  • Activities of daily living
  • Quality of life
  • Mobility
Not Provided
Not Provided
Argus® II Retinal Stimulation System Feasibility Protocol
Argus® II Retinal Stimulation System Feasibility Protocol
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.
Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Retinitis Pigmentosa
Device: Argus II Retinal Stimulation System
epiretinal implantation of device
Active Comparator: Implant of Argus II Retinal Prosthesis
This is a single group study where the status and performance of the implanted eye prior to surgery serves as the comparator.
Intervention: Device: Argus II Retinal Stimulation System

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
August 2019
March 2012   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
France,   Mexico,   Switzerland,   United Kingdom,   United States
National Eye Institute (NEI) ( Other Grant/Funding Number: 2R01EY012893-06A1 )
Not Provided
Not Provided
Second Sight Medical Products
Second Sight Medical Products
National Eye Institute (NEI)
Study Director: Anne-Marie Ripley Second Sight Medical Products
Second Sight Medical Products
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP