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Argus II Retinal Prosthesis System Dry AMD Feasibility Study 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: NCT02227498
Recruitment Status : Active, not recruiting
First Posted : August 28, 2014
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Second Sight Medical Products

Tracking Information
First Submitted Date  ICMJE August 25, 2014
First Posted Date  ICMJE August 28, 2014
Last Update Posted Date September 26, 2019
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2017)
  • Adverse Events [ Time Frame: Up to 1 year ]
    The number of adverse events in implanted subjects.
  • Visual function [ Time Frame: 1 Year ]
    The primary effectiveness endpoint of the study is the effect of the Argus II System on monocular (implanted eye) and binocular visual function, as measured by a suite of visual function tests.
Original Primary Outcome Measures  ICMJE
 (submitted: August 27, 2014)
  • The number of adverse events in implanted subjects. [ Time Frame: Up to 1 year ]
  • Visual function [ Time Frame: 1 Year ]
    The primary effectiveness endpoint of the study is the effect of the Argus II System on monocular (implanted eye) and binocular visual function, as measured by a suite of visual function tests.
Change History Complete list of historical versions of study NCT02227498 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Argus II Retinal Prosthesis System Dry AMD Feasibility Study Protocol
Official Title  ICMJE Argus II Retinal Prosthesis System Dry AMD Feasibility Study Protocol
Brief Summary The purpose of this study is to test the Argus II Retinal Prosthesis System in patients with severe age-related macular degeneration (AMD). The Argus II System has already been studied in completely blind patients with retinitis pigmentosa (RP). In RP patients, some cells of the retina are irrevocably damaged and the Argus II System has been found to restore some basic visual function. On these grounds, the device has received authorization for use on the European market (the CE certification) in 2011.
Detailed Description In this study, 5 subjects with severe dry AMD who are legally blind will be implanted with the Argus II System. The study will evaluate the safety of the device and surgery, as well as functioning of the system and the extent of any restored vision. Each subject will be followed for 3 years, with their eye health and visual function tested at multiple time points.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Age Related Macular Degeneration
Intervention  ICMJE Device: Effect of Argus II on Functional Vision
To evaluate the safety and effectiveness of the Argus II Retinal Prosthesis in subjects with AMD.
Study Arms  ICMJE Experimental: Effect of Argus II on Functional Vision
All subjects enrolled in the study will be implanted with the Argus II Retinal Prosthesis. To evaluate safety and effectiveness of Argus II on visual function.
Intervention: Device: Effect of Argus II on Functional Vision
Publications * Not Provided

*   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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 27, 2014)
5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject must consent to participate in the study;
  2. Subject must be between 25 and 85 years of age;
  3. Subject must be diagnosed with dry AMD (i.e., evidence of drusen and hyperplasia of the RPE in the eye with geographic atrophy secondary to dry AMD);
  4. Severely sight impaired and meets the following additional criteria:

    1. Visual acuity of logMAR 1.0 (6/60) or worse in both eyes as measured by ETDRS;
    2. Hand motion or worse central vision in the eye to be implanted, as measured with a pinhole occluder;
    3. Geographic atrophy (confirmed by Fundus Autofluorescence) and central scotoma (confirmed by microperimetry) in the central 20° or more;
  5. Subject must be pseudophakic with an IOL successfully implanted in the study eye at least 2 weeks before baseline testing, or aphakic with a clear capsule. If applicable, posterior laser capsulotomy may be performed 2 weeks before baseline testing is performed;
  6. Subject must be both motivated and competent to learn to use the Argus II System (by the Investigator's assessment), and willing and able to commit to the study requirements. This includes an understanding of the requirements of the study and acceptance of the time involved in participating;
  7. Subject must not suffer from non-ophthalmic serious adverse events (e.g., myocardial infarction, etc.) or from non-curable life threatening conditions (e.g. cancer) at the time of the Baseline visit.

Exclusion Criteria:

  1. 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.);
  2. Evidence of active sub-macular choroidal neovascularization (CNV) in implanted eye;
  3. 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; abnormalities in the typical curvature of the retina like staphyloma and all causes of significant protrusions or depressions in the area centralis that could compromise the optimal position of the electrode array, active or severe blepharitis, etc.);
  4. Ocular diseases or conditions (other than cataracts) that prevent adequate visualization of the inner structures of the eye (e.g., corneal opacity);
  5. An Implantable Miniature Telescope in either eye;
  6. Pre-disposition to eye rubbing;
  7. 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;
  8. Pregnant or wish to become pregnant during the course of the study;
  9. Participating in another investigational drug or device study that may conflict with the objectives, follow-up or testing of this study;
  10. Inability to tolerate general anaesthesia or the recommended antibiotic and steroid regimen associated with the implantation surgery;
  11. Conditions likely to limit life to less than 1 year from the time of inclusion.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 85 Years   (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 United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02227498
Other Study ID Numbers  ICMJE CP-04-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Second Sight Medical Products
Study Sponsor  ICMJE Second Sight Medical Products
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jessy Dorn, PhD Second Sight Medical Products, Inc.
PRS Account Second Sight Medical Products
Verification Date September 2019

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