<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/NCT02228304</url>
  </required_header>
  <id_info>
    <org_study_id>NT-503-3-AMD-001</org_study_id>
    <nct_id>NCT02228304</nct_id>
  </id_info>
  <brief_title>Study of the Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology (ECT) for the Treatment of Recurrent Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)</brief_title>
  <official_title>A Multi-Center, Two-Stage, Open-Label Phase I and Randomized, Active Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology Compared With Eylea for the Treatment of Recurrent CNV Secondary to AMD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neurotech Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Neurotech Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, multi-center 2-stage study. Stage 1 (Phase I) is open-label with all patients&#xD;
      treated with the NT-503-3 ECT implant. Stage 1 (Phase I) patients will undergo explantation&#xD;
      at year 2. Those who, in the opinion of the investigator, are still candidates for continued&#xD;
      anti-VEGF therapy will be re-implanted with a new NT-503-3 investigational product and&#xD;
      followed for an additional 12 weeks before study exit. Stage 2 (Phase II) is a separate,&#xD;
      randomized, masked phase during which eligible patients will be randomized to the NT-503-3&#xD;
      group or the control group.&#xD;
&#xD;
      Clinical Hypotheses:&#xD;
&#xD;
        -  NT-503-3 ECT is comparable to Eylea® injected intravitreally every 8 weeks in the&#xD;
           prevention of vision loss due to recurrent CNV secondary to AMD&#xD;
&#xD;
        -  NT-503-3 ECT has an acceptable safety profile&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    After enrolling approximately 1/2 of the trial participants, the rescues exceeded stopping&#xD;
    criteria.&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients with less than a 3-line loss of BCVA in ETDRS letters</measure>
    <time_frame>Week 52 and Week 108</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in best corrected visual acuity (BCVA)</measure>
    <time_frame>Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in macular thickness as determined by Spectral Domain Optical Coherence Tomography (sdOCT)</measure>
    <time_frame>Up to Week 108</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean (median) number of Eylea® injections and number of patients requiring Eylea® injections for rescue therapy</measure>
    <time_frame>Up to Week 108</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>NT-503-3 ECT implantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Eylea® injected intravitreally every 8 weeks</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Eylea® injected intravitreally every 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NT-503-3 ECT implantation</intervention_name>
    <description>NT-503-3 ECT implantation is a biological sustained drug delivery device that could provide continuous delivery of an anti-VEGF therapy</description>
    <arm_group_label>NT-503-3 ECT implantation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eylea® injected intravitreally administered every 8 weeks</intervention_name>
    <description>The first part, stage 1, Phase I is open label with the experimental treatment arm only. Eylea® injected intravitreally is only used as a comparator in the stage 2, Phase II, portion of the study.</description>
    <arm_group_label>Eylea® injected intravitreally every 8 weeks</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Active (recurrent or persistent) subfoveal CNV lesions secondary to AMD&#xD;
             in the study eye&#xD;
&#xD;
          -  Prior Intravitreal Anti-VEGF injections&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Significant subretinal hemorrhage&#xD;
&#xD;
          -  Significant Scar and/or, fibrosis&#xD;
&#xD;
          -  Suspected polypoidal choroidopathy, or pigment epithelial tears or rips&#xD;
&#xD;
          -  Inadequate response to anti-VEGF therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles Johnson, MB, ChB</last_name>
    <role>Study Chair</role>
    <affiliation>Neurotech Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Associated Retina Consultants, Ltd.</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina-Vitreous Associates Medical Group</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, Irvine, The Gavin Herbert Eye Institute</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jacobs Retina Center at UCSD</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Retina Associates</name>
      <address>
        <city>Golden</city>
        <state>Colorado</state>
        <zip>80401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Health Center</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Ophthalmic Research Institute</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Retina and Macular Disease</name>
      <address>
        <city>Winter Haven</city>
        <state>Florida</state>
        <zip>33880</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeast Retina Center, PC</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgina Retina, P.C.</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois Retina Associates, S.C.</name>
      <address>
        <city>Joliet</city>
        <state>Illinois</state>
        <zip>60435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois Retina Associates</name>
      <address>
        <city>Oak Park</city>
        <state>Illinois</state>
        <zip>60304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Associates of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Retina Group of Washington</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cumberland Valley Retina Consultants, PC</name>
      <address>
        <city>Hagerstown</city>
        <state>Maryland</state>
        <zip>21740</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmic Consultants of Boston</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan, Kellogg Eye Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Beaumont Hospital-Ophthalmology Research</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lifelong Vision Foundation</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sierra Eye Associates</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Center of New Jersey, LLC</name>
      <address>
        <city>Bloomfield</city>
        <state>New Jersey</state>
        <zip>07003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NJ Retina</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Carolina Retinal Associates</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Health Eye Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Northwest, PC</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid Atlantic Retina</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palmetto Retina Center, LLC</name>
      <address>
        <city>Florence</city>
        <state>South Carolina</state>
        <zip>29501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Black Hills Regional Eye Institute</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Retina Institute, PA</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Ophthalmology Associates</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soroka Medical Center</name>
      <address>
        <city>Beer Sheva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah-Hebrew University Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center</name>
      <address>
        <city>Kfar Saba</city>
        <zip>44281</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petach-tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaplan Medical Center</name>
      <address>
        <city>Rehovot</city>
        <zip>76100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sourasky Medical Center,</name>
      <address>
        <city>Tel-Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <disposition_first_submitted>November 15, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>November 15, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">November 16, 2016</disposition_first_posted>
  <last_update_submitted>July 14, 2022</last_update_submitted>
  <last_update_submitted_qc>July 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Wet AMD</keyword>
  <keyword>Wet Age Related Macular Degeneration</keyword>
  <keyword>Recurrent CNV Secondary to AMD</keyword>
  <keyword>Active subfoveal CNV</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, but a results disposition has been submitted           -->
</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/NCT02228304
org study id: NT-503-3-AMD-001
nct id: NCT02228304
lead sponsor: 
has dmc: Yes
Prospective, multi-center 2-stage study. Stage 1 (Phase I) is open-label with all patients
      treated with the NT-503-3 ECT implant. Stage 1 (Phase I) patients will undergo explantation
      at year 2. Those who, in the opinion of the investigator, are still candidates for continued
      anti-VEGF therapy will be re-implanted with a new NT-503-3 investigational product and
      followed for an additional 12 weeks before study exit. Stage 2 (Phase II) is a separate,
      randomized, masked phase during which eligible patients will be randomized to the NT-503-3
      group or the control group.

      Clinical Hypotheses:

        -  NT-503-3 ECT is comparable to Eylea® injected intravitreally every 8 weeks in the
           prevention of vision loss due to recurrent CNV secondary to AMD

        -  NT-503-3 ECT has an acceptable safety profile
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Percentage of patients with less than a 3-line loss of BCVA in ETDRS letters
time frame: Week 52 and Week 108
measure: Change from baseline in best corrected visual acuity (BCVA)
time frame: Week 52
measure: Change from baseline in macular thickness as determined by Spectral Domain Optical Coherence Tomography (sdOCT)
time frame: Up to Week 108
measure: Mean (median) number of Eylea® injections and number of patients requiring Eylea® injections for rescue therapy
time frame: Up to Week 108
arm group label: NT-503-3 ECT implantation
arm group type: Experimental
arm group label: Eylea® injected intravitreally every 8 weeks
arm group type: Active Comparator
description: Eylea® injected intravitreally every 8 weeks
intervention type: Drug
intervention name: NT-503-3 ECT implantation
description: NT-503-3 ECT implantation is a biological sustained drug delivery device that could provide continuous delivery of an anti-VEGF therapy
arm group label: NT-503-3 ECT implantation
intervention type: Drug
intervention name: Eylea® injected intravitreally administered every 8 weeks
description: The first part, stage 1, Phase I is open label with the experimental treatment arm only. Eylea® injected intravitreally is only used as a comparator in the stage 2, Phase II, portion of the study.
arm group label: Eylea® injected intravitreally every 8 weeks
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Charles Johnson, MB, ChB
role: Study Chair
affiliation: Neurotech Pharmaceuticals, Inc.
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country: Israel
country: United States
responsible party type: Sponsor
mesh term: Macular Degeneration