ARGUS II RETINAL STIMULATION SYSTEM

Argus™ II Retinal Stimulation System Feasibility Protocol

This study is ongoing, but not recruiting participants.

First Received: December 1, 2006   Last Updated: November 10, 2009   History of Changes

Sponsor:	Second Sight Medical Products
Collaborator:	National Institutes of Health (NIH)
Information provided by:	Second Sight Medical Products
ClinicalTrials.gov Identifier:	NCT00407602

  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 II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Uncontrolled 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:

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndromeretinitis pigmentosa X-linked juvenile retinoschisis Help Me Understand Genetics

U.S. FDA Resources

Further study details as provided by Second Sight Medical Products:

Primary Outcome Measures:

• Visual acuity [ Time Frame: 3 years ] [ Designated as safety issue: No ]
• Safety [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

• Activities of daily living [ Time Frame: 3 years ] [ Designated as safety issue: No ]
• Quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]
• Mobility [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	September 2006

  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

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