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Argus II Retinal Prosthesis System - Better Vision RP Study

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ClinicalTrials.gov Identifier: NCT03418116
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Second Sight Medical Products

Brief Summary:
The study is conducted to evaluate the safety and benefit of the Argus II System in a selected patient population with advanced Retinitis Pigmentosa who have a measurable central residual visual field smaller than or equal to 5 degrees radius.

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Device: Argus II Retinal Prosthesis Not Applicable

Detailed Description:

The Argus II System is intended for use in blind patients with severe to profound retinitis pigmentosa with at least some light perception in the eye to be implanted.

The majority of RP patients still have some central vision even at a very late stage of the disease. This extremely restricted visual field is, however, highly disabling in daily life. The primary objective of this study is to evaluate the safety and benefit of the Argus II System in RP patients characterized as late stage with a central residual visual field smaller than or equal to 5 degrees radius . The electrode array will be placed in a para- to peri foveal location adjacent to the subject's residual visual field, thus increasing the total retinal area receptive to light.

Safety data will be monitored to ensure continued acceptability of risks to study subjects and visual function will be measured to evaluate the effectiveness of the system in this "better vision" RP population. In addition, effects on functional vision and quality of life will be assessed through the Functional Low-Vision Observer Rated Assessment (FLORA) and the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Argus II Retinal Prosthesis System - Better Vision RP Study
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020


Arm Intervention/treatment
Experimental: Argus II
Implantation of the Argus II Retinal Prosthesis in patients with advanced Retinitis Pigmentosa who have a measurable central residual visual field smaller than or equal to 5 degrees radius. The array will be placed parafoveally, adjacent to the preserved central visual field (i.e., "tunnel vision") in these subjects.
Device: Argus II Retinal Prosthesis
The Argus II System is designed to provide visual function to individuals with severe to profound vision loss due to outer retinal degeneration. It consists of implanted and external components. The implant is an epiretinal prosthesis that is surgically implanted in and around the eye. The external equipment includes glasses and a video processing unit (VPU). The glasses include a miniature video camera, which captures video images, and a coil that sends data and stimulation commands to the implant. The VPU converts the video images into stimulation commands and is body-worn. The Argus II System operates by converting video images into electrical energy that activates retinal cells, delivering the signal through the optic nerve to the brain where it is perceived as light.




Primary Outcome Measures :
  1. Adverse events [ Time Frame: 2 Years ]
    The nature and number of adverse events in implanted subjects.

  2. Visual field [ Time Frame: 2 Years ]
    The effect of the Argus II System on visual field size, as measured by Goldmann perimetry


Secondary Outcome Measures :
  1. Visual function [ Time Frame: 2 Years ]
    Effect of the Argus II System on visual function, as measured by a suite of visual tests

  2. Quality of Life [ Time Frame: 2 Years ]
    Effect of the Argus II System on quality of life, as measured by the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)

  3. Functional vision and quality of life [ Time Frame: 2 Years ]
    The general impact of the Argus II on subject's lives, as measured by the Functional Low-Vision Observer Rated Assessment (FLORA)



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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults, age 25 years or older;
  • Diagnosed with advanced Retinitis Pigmentosa (including syndromic RP), Choroideremia, Leber's Congenital Amaurosis, or Rod-Cone disease;
  • A measurable central residual visual field of 5° radius or smaller in both eyes, as determined by Goldmann perimetry;
  • Visual acuity of 0.1 (1.0 logMAR) or worse in the eye to be implanted, as measured by ETDRS chart;
  • Previous history of useful form vision;
  • Provided written, informed consent to participate in the study.

Exclusion Criteria:

  • Ocular diseases or conditions that could prevent the Argus II implant from working (e.g., optic nerve disease, central retinal artery or vein occlusion, history of retinal detachment, trauma, etc.);
  • Ocular structures or conditions that could prevent the successful implantation of the Argus II Implant or adequate healing from surgery (e.g. extremely thin conjunctiva; axial length <20.5 mm or > 26 mm; corneal ulcers; choroidal neovascularization in the area of the intended tack location, etc.);
  • Pre-disposition to eye rubbing;
  • Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols, including:

    1. cognitive decline including diagnosed forms of dementia and/or progressive neurologic disease,
    2. psychiatric disease including diagnosed forms of depression;
    3. does not speak a principal language associated with the region, and
    4. deafness or selective frequency hearing loss that prevents hearing device alarms and alerts;
  • Pregnant or wish to become pregnant during the course of the study;
  • Participating in another investigational drug or device study that may conflict with the objectives, follow-up, or testing of this study;
  • Inability to tolerate general anaesthesia or the recommended antibiotic and steroid regimen associated with the implantation surgery;
  • Conditions likely to limit life to less than 1 year from the time of inclusion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418116


Contacts
Contact: Nancy Ouch 818 833-5058 patients@secondsight.com
Contact: Annette Bastian, PhD +41 21 353 0274 patients@secondsight.com

Locations
Germany
Augenklinik Städtisches Klinikum Karlsruhe Recruiting
Karlsruhe, Baden-Wurttemberg, Germany, 76133
Contact: Jenny Atorf, Dr. rer. nat    +49-721-974-2034    jenny.atorf@gmail.com   
Principal Investigator: Albert J Augustin, Prof Dr med         
University Medical Center Schleswig-Holstein, Department of Ophthalmology Recruiting
Lübeck, Schleswig-Holstein, Germany, 23538
Contact: Nadine Schoenberg    +49 451 500 43913    nadine.schoenberg@uksh.de   
Principal Investigator: Salvatore Grisanti, Prof Dr med         
RWTH University Eye Clinic Recruiting
Aachen, Germany, 52074
Contact: Kim Schaffrath, M.D.    +49-241-8088192    kischaffrath@ukaachen.de   
Principal Investigator: Peter Walter, Prof Dr med         
Sponsors and Collaborators
Second Sight Medical Products
Investigators
Principal Investigator: Peter Walter, Prof Dr med RWTH Aachen University

Responsible Party: Second Sight Medical Products
ClinicalTrials.gov Identifier: NCT03418116     History of Changes
Other Study ID Numbers: CP-08-01
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

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