<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/NCT02988895</url>
  </required_header>
  <id_info>
    <org_study_id>SMD-201601</org_study_id>
    <nct_id>NCT02988895</nct_id>
  </id_info>
  <brief_title>Episcleral Brachytherapy for the Treatment of Wet AMD</brief_title>
  <acronym>NEAMES</acronym>
  <official_title>A Prospective Study of Episcleral Brachytherapy for the Treatment of Neovascular Age-related Macular Degeneration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Salutaris Medical Devices, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Salutaris Medical Devices, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multi-site, safety and feasibility study of the SalutarisMD SMD-DA&#xD;
      system for retrobulbar minimally invasive episcleral brachytherapy device in patients&#xD;
      receiving and not responding to anti-VEGF therapy for nAMD. The trial will be open label and&#xD;
      non-randomized. The study intervention is a one-time intervention and requires no alteration&#xD;
      to the standard of care during the follow-up period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will receive a single brachytherapy treatment and 36 months of follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">May 2025</completion_date>
  <primary_completion_date type="Actual">May 26, 2023</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 of the study intervention</measure>
    <time_frame>26 weeks</time_frame>
    <description>Adverse event assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tolerability of the study intervention</measure>
    <time_frame>During procedure</time_frame>
    <description>Subject pain score during procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of the study intervention</measure>
    <time_frame>1 day</time_frame>
    <description>Investigator ability to place the device and deliver a therapeutic dose</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Macular Degeneration, Choroidal Neovascularization</condition>
  <arm_group>
    <arm_group_label>episcleral brachytherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single fraction of 24 Gy Strontium90 episcleral brachytherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>episcleral brachytherapy</intervention_name>
    <description>The study intervention is an outpatient, ambulatory procedure performed under local anesthesia with anesthesia assist.</description>
    <arm_group_label>episcleral brachytherapy</arm_group_label>
    <other_name>Strontium 90</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of active CNV or PCV due to nAMD&#xD;
&#xD;
          -  Poor or non-responsive to FDA approved intravitreal anti-VEGF therapy for nAMD&#xD;
&#xD;
          -  BCVA 20/63 or worse Snellen equivalent in the study eye&#xD;
&#xD;
          -  Ability to understand nature/purpose of trial and to provide informed consent&#xD;
&#xD;
          -  Ability to undergo diagnostic tests and surgical interventions&#xD;
&#xD;
          -  Ability to follow instructions and complete the trial including all scheduled visits&#xD;
             and follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neovascularization other than due to AMD&#xD;
&#xD;
          -  Sub-foveal lesion hemorrhage obscuring &gt;50% of lesion&#xD;
&#xD;
          -  Targeted neovascular lesion with greatest linear dimension &gt;3750 microns or &lt;1000&#xD;
             microns as determined by angiography&#xD;
&#xD;
          -  Presence of subretinal fibrosis, including disciform scar, or retinal pigment&#xD;
             epithelial (RPE) atrophy that is extensive or foveal threatening in the study eye&#xD;
&#xD;
          -  An existing retinal pigment epithelial (RPE) tear&#xD;
&#xD;
          -  Previous treatment (excluding vitamins) for nAMD in the study eye other than anti-VEGF&#xD;
             therapy in the last 6 months&#xD;
&#xD;
          -  A change in anti-VEGF agent in the previous two administrations&#xD;
&#xD;
          -  Anticipate a change to the anti-VEGF agent during the conduct of the study&#xD;
&#xD;
          -  Other clinically significant ocular co-morbidity including, but not limited to,&#xD;
             glaucoma, optic neuropathy of any cause, maculopathy / retinopathy of any cause other&#xD;
             than nAMD, scleritis, enophthalmos, microphthalmia, or other co-morbidities that in&#xD;
             the investigator's opinion could require medical or surgical intervention to prevent&#xD;
             or treat visual loss or media opacity that might result from that condition (i.e.&#xD;
             severe cataracts).&#xD;
&#xD;
          -  Previous intraocular surgery in study eye other than for uncomplicated&#xD;
             phacoemulsification cataract extraction&#xD;
&#xD;
          -  High myopia indicated by a history of refractive error of - 6D or greater (spherical&#xD;
             equivalent), demonstrated myopic degeneration, or axial length of &gt;26.5mm.&#xD;
&#xD;
          -  Subjects with orbital structural abnormalities, such as small (axial length &lt;21 mm),&#xD;
             deep set globes or other globe dystopias that, in the investigator's clinical&#xD;
             judgment, would require a change in the angle of insertion or increase the risk of&#xD;
             structural damage from retrobulbar anesthesia, sub-Tenon's anesthesia, or retrobulbar&#xD;
             device positioning.&#xD;
&#xD;
          -  Media opacity sufficient to preclude adequate fundoscopy, OCT, or angiography&#xD;
&#xD;
          -  Uncontrolled systemic diseases (e.g. controlled hypertension is acceptable)&#xD;
&#xD;
          -  Type I or type II diabetes mellitus&#xD;
&#xD;
          -  Any previous therapeutic radiation to the head or neck or other areas that may have&#xD;
             resulted in a radiation dose to the retina.&#xD;
&#xD;
          -  On anticoagulation or dual anti-platelet therapy with abnormal coagulation panel&#xD;
             results.&#xD;
&#xD;
          -  Patient unsuitable for IV or local anesthesia&#xD;
&#xD;
          -  Any contraindication to anti-VEGF, fluorescein, indocyanine green, topical and local&#xD;
             anesthetics, topical antiseptics, or topical antibiotics to be used during the study&#xD;
&#xD;
          -  Active ocular or periocular infection or intraocular inflammation&#xD;
&#xD;
          -  Fellow eye with a BCVA of 20/63 Snellen Equivalent or worse, with advanced AMD&#xD;
             (neovascular or non-exudative AMD with foveal geographic atrophy), or other vision&#xD;
             threatening disease that is not eligible for vision restoring treatment (i.e.&#xD;
             inoperable cataracts).&#xD;
&#xD;
          -  Fellow eye is receiving anti-VEGF therapy&#xD;
&#xD;
          -  Have received any investigational treatment for any indication in the previous 30 days&#xD;
&#xD;
          -  Any condition which, in the investigators' opinion, would conflict or otherwise&#xD;
             prevent the subject from complying with the required procedures, schedule or other&#xD;
             study conduct&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Retina Consultants of Hawaii</name>
      <address>
        <city>'Aiea</city>
        <state>Hawaii</state>
        <zip>96701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Retina</name>
      <address>
        <city>Oak Forest</city>
        <state>Illinois</state>
        <zip>60452</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>August 28, 2023</last_update_submitted>
  <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Brachytherapy</keyword>
  <keyword>Wet AMD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Choroidal Neovascularization</mesh_term>
    <mesh_term>Neovascularization, Pathologic</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/NCT02988895
org study id: SMD-201601
nct id: NCT02988895
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This is a prospective, multi-site, safety and feasibility study of the SalutarisMD SMD-DA
      system for retrobulbar minimally invasive episcleral brachytherapy device in patients
      receiving and not responding to anti-VEGF therapy for nAMD. The trial will be open label and
      non-randomized. The study intervention is a one-time intervention and requires no alteration
      to the standard of care during the follow-up period.
Subjects will receive a single brachytherapy treatment and 36 months of follow-up.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety of the study intervention
time frame: 26 weeks
description: Adverse event assessment
measure: Tolerability of the study intervention
time frame: During procedure
description: Subject pain score during procedure
measure: Feasibility of the study intervention
time frame: 1 day
description: Investigator ability to place the device and deliver a therapeutic dose
arm group label: episcleral brachytherapy
arm group type: Experimental
description: single fraction of 24 Gy Strontium90 episcleral brachytherapy
intervention type: Radiation
intervention name: episcleral brachytherapy
description: The study intervention is an outpatient, ambulatory procedure performed under local anesthesia with anesthesia assist.
arm group label: episcleral brachytherapy
other name: Strontium 90
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Choroidal Neovascularization
mesh term: Neovascularization, Pathologic
sharing ipd: No