<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/NCT01731964</url>
  </required_header>
  <id_info>
    <org_study_id>WA-NG-001 ASSAF HAROFEH</org_study_id>
    <nct_id>NCT01731964</nct_id>
  </id_info>
  <brief_title>Study of WA-NG Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration</brief_title>
  <official_title>Pilot Study of WA-NG Telescope Prosthesis in Patients With Central Vision Impairment Associated With End-stage Age-related Macular Degeneration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VisionCare, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VisionCare, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study to evaluate the safety of the Model WA-NG telescope prosthesis in&#xD;
      patients with bilateral moderate to profound central vision impairment due to end-stage&#xD;
      age-related macular degeneration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be screened for eligibility and informed consent will be obtained from those&#xD;
      who meet screening criteria and are interested in participating in the study. Eligible&#xD;
      patients will be examined preoperatively to obtain a medical history and to establish a&#xD;
      baseline for ocular condition. Baseline measurements will include successful use of an&#xD;
      external telescope.&#xD;
&#xD;
      Postoperatively, patients will undergo ophthalmic evaluation at regular intervals as&#xD;
      specified in this protocol and will be required to return for 6 to 10 additional visits for&#xD;
      vision training with a low vision specialist.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No participants enrolled&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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>Safety</measure>
    <time_frame>12 months</time_frame>
    <description>Positional stability assessed by slit lamp examination and anterior segment OCT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>12 months</time_frame>
    <description>adverse events</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Age Related Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>WA- NG Telescope Prothesis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implantable Miniature Telescope for end stage AMD</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Telescope prosthesis</intervention_name>
    <description>Monocular implantation of the telescope prosthesis after cataract extraction</description>
    <arm_group_label>WA- NG Telescope Prothesis</arm_group_label>
    <other_name>IMT-NG</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>WA-NG Telescope Prothesis</intervention_name>
    <description>The WA-NG telescope prosthesis (Figure 1) is the next generation telescopic implantable device which, when combined with the optics of the cornea, constitutes a telephoto system for improvement of visual acuity in patients with severe to profound vision impairment due to bilateral, end-stage age-related macular degeneration. The device is implanted in one of the patient's eyes. In this way, the implanted eye provides central vision and the non-implanted eye can continue to provide peripheral vision.</description>
    <arm_group_label>WA- NG Telescope Prothesis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Bi-lateral, stable, moderate to profound (20/80 to 20/800) central vision impairment due to&#xD;
        bilateral scotoma associated with end-stage macular degeneration, defined as retinal finds&#xD;
        of bilateral, geographic atrophy or disciform scar with foveal involvment. Phakic in the&#xD;
        operative eye. Must achieve a 5 letter improved with external telescope simulator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Evidence of active CNV or any ophthalmic pathology that compromises peripheral vision of&#xD;
        fellow eye or predisposes eye rubbing. Previous intraocular of corneal surgery of any kind&#xD;
        in operative eye. Retinal disease, optic nerve disease, diabetic retinopathy, retinal&#xD;
        tears, or any introcular tumor or medical or ophthalmic condition that in the opinion of&#xD;
        the investigator renders the subject unsuitable for participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Isaac Avni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assaf-Harofeh Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assaf Harofeh Medical Center</name>
      <address>
        <city>Zerifin</city>
        <zip>70300</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>December 10, 2014</last_update_submitted>
  <last_update_submitted_qc>December 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Macular Degeneration</keyword>
  <keyword>Visual Impairment</keyword>
  <keyword>Implantable Telescope</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
  </condition_browse>
  <!-- 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/NCT01731964
org study id: WA-NG-001 ASSAF HAROFEH
nct id: NCT01731964
lead sponsor: 
has dmc: No
This is a pilot study to evaluate the safety of the Model WA-NG telescope prosthesis in
      patients with bilateral moderate to profound central vision impairment due to end-stage
      age-related macular degeneration.
Patients will be screened for eligibility and informed consent will be obtained from those
      who meet screening criteria and are interested in participating in the study. Eligible
      patients will be examined preoperatively to obtain a medical history and to establish a
      baseline for ocular condition. Baseline measurements will include successful use of an
      external telescope.

      Postoperatively, patients will undergo ophthalmic evaluation at regular intervals as
      specified in this protocol and will be required to return for 6 to 10 additional visits for
      vision training with a low vision specialist.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety
time frame: 12 months
description: Positional stability assessed by slit lamp examination and anterior segment OCT
measure: Safety
time frame: 12 months
description: adverse events
arm group label: WA- NG Telescope Prothesis
arm group type: Experimental
description: Implantable Miniature Telescope for end stage AMD
intervention type: Device
intervention name: Telescope prosthesis
description: Monocular implantation of the telescope prosthesis after cataract extraction
arm group label: WA- NG Telescope Prothesis
other name: IMT-NG
intervention type: Device
intervention name: WA-NG Telescope Prothesis
description: The WA-NG telescope prosthesis (Figure 1) is the next generation telescopic implantable device which, when combined with the optics of the cornea, constitutes a telephoto system for improvement of visual acuity in patients with severe to profound vision impairment due to bilateral, end-stage age-related macular degeneration. The device is implanted in one of the patient's eyes. In this way, the implanted eye provides central vision and the non-implanted eye can continue to provide peripheral vision.
arm group label: WA- NG Telescope Prothesis
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Isaac Avni, MD
role: Principal Investigator
affiliation: Assaf-Harofeh Medical Center
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Macular Degeneration