Argus® II Retinal Stimulation System Feasibility Protocol

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Second Sight Medical Products
ClinicalTrials.gov Identifier:
NCT00407602
First received: December 1, 2006
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Retinitis Pigmentosa
Device: Argus II Retinal Stimulation System
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Argus® II Retinal Stimulation System Feasibility Protocol

Resource links provided by NLM:


Further study details as provided by Second Sight Medical Products:

Primary Outcome Measures:
  • Visual acuity [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Activities of daily living [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Orientation and Mobility [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Spatial Vision [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Stability of Implant [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • System Functionality [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2006
Estimated Study Completion Date: August 2019
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: Argus II Retinal Stimulation System
epiretinal implantation of device

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407602

Locations
United States, California
Doheny Eye Institute
Los Angeles, California, United States, 90033
University of California San Francisco
San Francisco, California, United States, 94143
United States, Maryland
Johns Hopkins, Wilmer Eye Institute
Baltimore, Maryland, United States, 21205
United States, New York
Columbia University, Department of Ophthalmology, Edward S. Harkness Eye Institute
New York, New York, United States, 10032
United States, Pennsylvania
University of Pennsylvania, Scheie Eye Institute
Philadelphia, Pennsylvania, United States, 19104
Wills Eye Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Retina Foundation of the Southwest
Dallas, Texas, United States, 75231
France
Centre d'Investigation Clinique, Service d'Ophtalmologie, Quinze-Vingts National Eye Hospital, 28 rue de Charenton, 75557 Cedex 12
Paris, France
Mexico
Puerta de Hierro, Centro Medico, Centro de Retina
Zapopan, Jalisco, Mexico, 51116
Switzerland
Clinique d'Ophthalmologie Hopitaux, Universitaires de Geneve 22 rue Alcide Jentzer 1205
Geneva, Switzerland
United Kingdom
Moorfields Eye Hospital, Vitreoretinal Research Unit
London, United Kingdom, EC1V 2PD
Manchester Royal Eye Hospital
Manchester, United Kingdom
Sponsors and Collaborators
Second Sight Medical Products
Investigators
Study Director: Anne-Marie Ripley Second Sight Medical Products
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Second Sight Medical Products
ClinicalTrials.gov Identifier: NCT00407602     History of Changes
Other Study ID Numbers: CP-003-001, National Eye Institute (NEI)
Study First Received: December 1, 2006
Last Updated: August 16, 2013
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Mexico: Federal Commission for Sanitary Risks Protection
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Second Sight Medical Products:
retinitis pigmentosa
device
retinal implant
retinal prosthesis
RP
outer retinal degeneration

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Retinal Degeneration
Retinal Diseases
Retinal Dystrophies

ClinicalTrials.gov processed this record on October 29, 2014