<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02227498</url>
  </required_header>
  <id_info>
    <org_study_id>CP-04-01</org_study_id>
    <nct_id>NCT02227498</nct_id>
  </id_info>
  <brief_title>Argus II Retinal Prosthesis System Dry AMD Feasibility Study Protocol</brief_title>
  <official_title>Argus II Retinal Prosthesis System Dry AMD Feasibility Study Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Sight Medical Products</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Sight Medical Products</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the Argus II Retinal Prosthesis System in patients with&#xD;
      severe age-related macular degeneration (AMD). The Argus II System has already been studied&#xD;
      in completely blind patients with retinitis pigmentosa (RP). In RP patients, some cells of&#xD;
      the retina are irrevocably damaged and the Argus II System has been found to restore some&#xD;
      basic visual function. On these grounds, the device has received authorization for use on the&#xD;
      European market (the CE certification) in 2011.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, 5 subjects with severe dry AMD who are legally blind will be implanted with&#xD;
      the Argus II System. The study will evaluate the safety of the device and surgery, as well as&#xD;
      functioning of the system and the extent of any restored vision. Each subject will be&#xD;
      followed for 3 years, with their eye health and visual function tested at multiple time&#xD;
      points.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Actual">March 2020</completion_date>
  <primary_completion_date type="Actual">September 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>The number of adverse events in implanted subjects.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual function</measure>
    <time_frame>1 Year</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">5</enrollment>
  <condition>Age Related Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>Effect of Argus II on Functional Vision</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Effect of Argus II on Functional Vision</intervention_name>
    <description>To evaluate the safety and effectiveness of the Argus II Retinal Prosthesis in subjects with AMD.</description>
    <arm_group_label>Effect of Argus II on Functional Vision</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject must consent to participate in the study;&#xD;
&#xD;
          2. Subject must be between 25 and 85 years of age;&#xD;
&#xD;
          3. Subject must be diagnosed with dry AMD (i.e., evidence of drusen and hyperplasia of&#xD;
             the RPE in the eye with geographic atrophy secondary to dry AMD);&#xD;
&#xD;
          4. Severely sight impaired and meets the following additional criteria:&#xD;
&#xD;
               1. Visual acuity of logMAR 1.0 (6/60) or worse in both eyes as measured by ETDRS;&#xD;
&#xD;
               2. Hand motion or worse central vision in the eye to be implanted, as measured with&#xD;
                  a pinhole occluder;&#xD;
&#xD;
               3. Geographic atrophy (confirmed by Fundus Autofluorescence) and central scotoma&#xD;
                  (confirmed by microperimetry) in the central 20° or more;&#xD;
&#xD;
          5. Subject must be pseudophakic with an IOL successfully implanted in the study eye at&#xD;
             least 2 weeks before baseline testing, or aphakic with a clear capsule. If applicable,&#xD;
             posterior laser capsulotomy may be performed 2 weeks before baseline testing is&#xD;
             performed;&#xD;
&#xD;
          6. Subject must be both motivated and competent to learn to use the Argus II System (by&#xD;
             the Investigator's assessment), and willing and able to commit to the study&#xD;
             requirements. This includes an understanding of the requirements of the study and&#xD;
             acceptance of the time involved in participating;&#xD;
&#xD;
          7. Subject must not suffer from non-ophthalmic serious adverse events (e.g., myocardial&#xD;
             infarction, etc.) or from non-curable life threatening conditions (e.g. cancer) at the&#xD;
             time of the Baseline visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Ocular diseases or conditions that could prevent the Argus II implant from working&#xD;
             (e.g., optic nerve disease, central retinal artery or vein occlusion, history of&#xD;
             retinal detachment, trauma, etc.);&#xD;
&#xD;
          2. Evidence of active sub-macular choroidal neovascularization (CNV) in implanted eye;&#xD;
&#xD;
          3. Ocular structures or conditions that could prevent the successful implantation of the&#xD;
             Argus II Implant or adequate healing from surgery (e.g. extremely thin conjunctiva;&#xD;
             axial length &lt;20.5 mm or &gt; 26 mm; corneal ulcers; abnormalities in the typical&#xD;
             curvature of the retina like staphyloma and all causes of significant protrusions or&#xD;
             depressions in the area centralis that could compromise the optimal position of the&#xD;
             electrode array, active or severe blepharitis, etc.);&#xD;
&#xD;
          4. Ocular diseases or conditions (other than cataracts) that prevent adequate&#xD;
             visualization of the inner structures of the eye (e.g., corneal opacity);&#xD;
&#xD;
          5. An Implantable Miniature Telescope in either eye;&#xD;
&#xD;
          6. Pre-disposition to eye rubbing;&#xD;
&#xD;
          7. Any disease or condition that prevents understanding or communication of informed&#xD;
             consent, study demands, and testing protocols, including:&#xD;
&#xD;
               1. cognitive decline including diagnosed forms of dementia and/or progressive&#xD;
                  neurologic disease,&#xD;
&#xD;
               2. psychiatric disease including diagnosed forms of depression;&#xD;
&#xD;
               3. does not speak a principal language associated with the region, and&#xD;
&#xD;
               4. deafness or selective frequency hearing loss that prevents hearing device alarms&#xD;
                  and alerts;&#xD;
&#xD;
          8. Pregnant or wish to become pregnant during the course of the study;&#xD;
&#xD;
          9. Participating in another investigational drug or device study that may conflict with&#xD;
             the objectives, follow-up or testing of this study;&#xD;
&#xD;
         10. Inability to tolerate general anaesthesia or the recommended antibiotic and steroid&#xD;
             regimen associated with the implantation surgery;&#xD;
&#xD;
         11. Conditions likely to limit life to less than 1 year from the time of inclusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jessy Dorn, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Second Sight Medical Products, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Manchester Royal Eye Hospital</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>March 16, 2020</last_update_submitted>
  <last_update_submitted_qc>March 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02227498
org study id: CP-04-01
nct id: NCT02227498
lead sponsor: 
has dmc: Yes
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse Events
time frame: Up to 1 year
description: The number of adverse events in implanted subjects.
measure: Visual function
time frame: 1 Year
description: 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.
arm group label: Effect of Argus II on Functional Vision
arm group type: Experimental
description: 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 type: Device
intervention name: Effect of Argus II on Functional Vision
description: To evaluate the safety and effectiveness of the Argus II Retinal Prosthesis in subjects with AMD.
arm group label: Effect of Argus II on Functional Vision
criteria: 
gender: All
minimum age: 25 Years
maximum age: 85 Years
healthy volunteers: No
last name: Jessy Dorn, PhD
role: Study Director
affiliation: Second Sight Medical Products, Inc.
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Macular Degeneration
sharing ipd: No