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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.
 
ClinicalTrials.gov Identifier: NCT00407602
Recruitment Status : Unknown
Verified May 2015 by Second Sight Medical Products.
Recruitment status was:  Active, not recruiting
First Posted : December 5, 2006
Last Update Posted : May 29, 2015
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Second Sight Medical Products

Tracking Information
First Submitted Date  ICMJE December 1, 2006
First Posted Date  ICMJE December 5, 2006
Last Update Posted Date May 29, 2015
Study Start Date  ICMJE September 2006
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2012)
  • Visual acuity [ Time Frame: 5 years ]
  • Safety [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 1, 2006)
  • Visual acuity
  • Safety
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2006)
  • Activities of daily living
  • Quality of life
  • Mobility
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Argus® II Retinal Stimulation System Feasibility Protocol
Official Title  ICMJE Argus® II Retinal Stimulation System Feasibility Protocol
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Retinitis Pigmentosa
Intervention  ICMJE Device: Argus II Retinal Stimulation System
epiretinal implantation of device
Study Arms  ICMJE 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: January 29, 2009)
30
Original Enrollment  ICMJE
 (submitted: December 1, 2006)
10
Estimated Study Completion Date  ICMJE August 2019
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Mexico,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00407602
Other Study ID Numbers  ICMJE CP-003-001
National Eye Institute (NEI) ( Other Grant/Funding Number: 2R01EY012893-06A1 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Second Sight Medical Products
Study Sponsor  ICMJE Second Sight Medical Products
Collaborators  ICMJE National Eye Institute (NEI)
Investigators  ICMJE
Study Director: Anne-Marie Ripley Second Sight Medical Products
PRS Account Second Sight Medical Products
Verification Date May 2015

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