<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/NCT04468373</url>
  </required_header>
  <id_info>
    <org_study_id>WA-NG-001 EUROPE</org_study_id>
    <nct_id>NCT04468373</nct_id>
  </id_info>
  <brief_title>Study of WA-NG (NG-IMT) Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration</brief_title>
  <official_title>Study of the WA-NG (NG-IMT) 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety of the updated Model WA-NG telescope&#xD;
      prosthesis (hereafter WA-NG telescope), an injectable telescope device, in patients with&#xD;
      bilateral moderate to profound central vision impairment due to end-stage age-related macular&#xD;
      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.&#xD;
&#xD;
      Postoperatively, patients will undergo ophthalmic evaluation at regular intervals as&#xD;
      specified in this protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Development of next-generation device&#xD;
  </why_stopped>
  <start_date type="Actual">May 2015</start_date>
  <completion_date type="Actual">July 2020</completion_date>
  <primary_completion_date type="Actual">July 2020</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>Positional stabilitytilt (the following parameter will be measured/ assessed :device centered (yes/ no) questionnaire)</measure>
    <time_frame>12 months</time_frame>
    <description>Device positional stability will be assessed by slit lamp examination (microscope with a bright light used during an eye exam) and anterior segment Ocular Coherence Tomography (OCT is a non-invasive imaging test )</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positional stabilitytilt, the following parameter will be measured/ assessed : tilted (° C)</measure>
    <time_frame>12 months</time_frame>
    <description>Device positional stability will be assessed by slit lamp examination (microscope with a bright light used during an eye exam) and anterior segment Ocular Coherence Tomography (OCT is a non-invasive imaging test )</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positional stabilitytilt , the following parameter will be measured/ assessed : malpositioned (yes/no) questionnaire</measure>
    <time_frame>12 months</time_frame>
    <description>Device positional stability will be assessed by slit lamp examination (microscope with a bright light used during an eye exam) and anterior segment Ocular Coherence Tomography (OCT is a non-invasive imaging test )</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positional stabilitytilt , the following parameter will be measured/ assessed : endothelial cell count (Cells/mm2))</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Positional stabilitytilt , the following parameter will be measured/ assessed : Intraocular pressure (mmHg)</measure>
    <time_frame>12 months</time_frame>
    <description>Device positional stability will be assessed by slit lamp examination (microscope with a bright light used during an eye exam)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Adverse events associated with the implant and use of the device will be evaluated.</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Age Related Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>WA-NG (NG-IMT) Telescope Prothesis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implantable Miniature Telescope for end stage AMD (Age-related Macular Degeneration)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>WA-NG (NG-IMT) Telescope Prothesis</intervention_name>
    <description>The WA-NG telescope prosthesis 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 (NG-IMT) Telescope Prothesis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        **The following Inc. &amp; Exc. are sample and not completed list **&#xD;
&#xD;
        Main Exclusion Criteria:&#xD;
&#xD;
          -  Patients with bilateral, stable, moderate to profound central vision impairment due to&#xD;
             bilateral central scotoma associated with end-stage macular degeneration, defined as&#xD;
             retinal findings of bilateral, geographic atrophy or disciform scar with foveal&#xD;
             involvement.&#xD;
&#xD;
          -  Patients must have distance BCVA between 20/80 and 20/800, and adequate peripheral&#xD;
             vision in one eye (the non-implanted eye) to allow navigation&#xD;
&#xD;
          -  Patients must achieve at least a five letter improvement on the ETDRS chart in the eye&#xD;
             scheduled for surgery, with the external telescope simulator (ETS)&#xD;
&#xD;
          -  Patients must be available for the study duration of 12 months&#xD;
&#xD;
          -  Patients must be alert, mentally competent, and able to understand and comply with the&#xD;
             requirements of the clinical trial, and be personally motivated to abide by the&#xD;
             requirements and restrictions of the clinical trial.&#xD;
&#xD;
        Main Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of active CNV on fluorescein angiography or treatment for CNV within the past&#xD;
             six months.&#xD;
&#xD;
          -  Patients who may require fellow eye cataract extraction and intraocular lens&#xD;
             implantation during the 12 months following WA-NG telescope implantation. If fellow&#xD;
             eye cataract extraction is anticipated, this procedure should be performed at least 30&#xD;
             days prior to enrollment in the clinical study.&#xD;
&#xD;
          -  Patients who have had or are expected to have ophthalmic related surgery within the 30&#xD;
             days preceding implantation of the device.&#xD;
&#xD;
          -  Patients who have undergone previous intraocular or corneal surgery of any kind in the&#xD;
             operative eye(s), including any type of surgery for either refractive or therapeutic&#xD;
             purposes.&#xD;
&#xD;
          -  Patients participating in any other ophthalmic drug or device clinical trial during&#xD;
             the time of this clinical investigation&#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>Diane Gordon</last_name>
    <role>Study Director</role>
    <affiliation>VisionCare Ophthalmic Technologies</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mater Private Hospital</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VISSUM Ophthalmological Corporation</name>
      <address>
        <city>Alicante</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 10, 2020</last_update_submitted>
  <last_update_submitted_qc>July 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</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>
  <pending_results>
    <submitted>March 3, 2021</submitted>
    <returned>March 29, 2021</returned>
    <submitted>April 6, 2021</submitted>
    <returned>April 29, 2021</returned>
  </pending_results>
  <!-- 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/NCT04468373
org study id: WA-NG-001 EUROPE
nct id: NCT04468373
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the safety of the updated Model WA-NG telescope
      prosthesis (hereafter WA-NG telescope), an injectable telescope device, 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.

      Postoperatively, patients will undergo ophthalmic evaluation at regular intervals as
      specified in this protocol.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Positional stabilitytilt (the following parameter will be measured/ assessed :device centered (yes/ no) questionnaire)
time frame: 12 months
description: Device positional stability will be assessed by slit lamp examination (microscope with a bright light used during an eye exam) and anterior segment Ocular Coherence Tomography (OCT is a non-invasive imaging test )
measure: Positional stabilitytilt, the following parameter will be measured/ assessed : tilted (° C)
time frame: 12 months
description: Device positional stability will be assessed by slit lamp examination (microscope with a bright light used during an eye exam) and anterior segment Ocular Coherence Tomography (OCT is a non-invasive imaging test )
measure: Positional stabilitytilt , the following parameter will be measured/ assessed : malpositioned (yes/no) questionnaire
time frame: 12 months
description: Device positional stability will be assessed by slit lamp examination (microscope with a bright light used during an eye exam) and anterior segment Ocular Coherence Tomography (OCT is a non-invasive imaging test )
measure: Positional stabilitytilt , the following parameter will be measured/ assessed : endothelial cell count (Cells/mm2))
time frame: 12 months
measure: Positional stabilitytilt , the following parameter will be measured/ assessed : Intraocular pressure (mmHg)
time frame: 12 months
description: Device positional stability will be assessed by slit lamp examination (microscope with a bright light used during an eye exam)
measure: Number of Adverse events associated with the implant and use of the device will be evaluated.
time frame: 12 months
arm group label: WA-NG (NG-IMT) Telescope Prothesis
arm group type: Experimental
description: Implantable Miniature Telescope for end stage AMD (Age-related Macular Degeneration)
intervention type: Device
intervention name: WA-NG (NG-IMT) Telescope Prothesis
description: The WA-NG telescope prosthesis 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 (NG-IMT) Telescope Prothesis
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Diane Gordon
role: Study Director
affiliation: VisionCare Ophthalmic Technologies
facility: 
facility: 
country: Ireland
country: Spain
responsible party type: Sponsor
mesh term: Macular Degeneration
submitted: March 3, 2021
returned: March 29, 2021
submitted: April 6, 2021
returned: April 29, 2021