<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/NCT01714115</url>
  </required_header>
  <id_info>
    <org_study_id>Slakter 1234</org_study_id>
    <nct_id>NCT01714115</nct_id>
  </id_info>
  <brief_title>Use of Eylea for the Treatment of an Optic Nerve Hemangioma</brief_title>
  <official_title>Use of Eylea for the Treatment of an Optic Nerve Hemangioma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vitreous -Retina- Macula Consultants of New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Vitreous -Retina- Macula Consultants of New York</source>
  <brief_summary>
    <textblock>
      This is a single patient investigative treatment study. The patient was diagnosed with a&#xD;
      retinal tumor in one eye. In the last 2 years, the patient has been treated with all&#xD;
      available and conventional therapies, including intraocular injections of Avastin and&#xD;
      Lucentis, steroids, and photodynamic therapy. Any positive results were short-term, and&#xD;
      caused an eventual decline in central vision. Aflibercept has been shown to be effective&#xD;
      against the growth of new vessels, secondary to macular degeneration. This study proposes&#xD;
      that it may also be more effective in treating this particular patient and case. The study&#xD;
      treatment plan is for 6 months initially, with the intention to continue treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The treatment plan will be to administer aflibercept 2.0 mg intravitreally every two to four&#xD;
      weeks for at least six consecutive injections. Prior to initiation of therapy and at each&#xD;
      study visit, a full ophthalmic examination, best-corrected visual acuity, and a complete&#xD;
      review of systems to monitor for any toxicity will be performed. In addition, the&#xD;
      investigators will perform fluorescein and indocyanine green angiography at baseline and&#xD;
      obtain color fundus photographs as well as spectral domain OCT images to properly document&#xD;
      the extent and degree of activity of the vascular tumor at baseline and at all study visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>No longer available</overall_status>
  <study_type>Expanded Access</study_type>
  <condition>Retinal Hemangioma</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aflibercept</intervention_name>
    <description>2.0 mg Intravitreal Injection, every 2 to 4 weeks</description>
    <other_name>Eylea, VEGF Trap-Eye</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  retinal hemangioma&#xD;
&#xD;
          -  previously treated with conventional therapies, including Avastin, Lucentis, steroid,&#xD;
             and photodynamic therapy, with less than ideal results&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ongoing reevaluation of adverse events, including inflammation, elevated intraocular&#xD;
             pressure, or any suspected toxicity from aflibercept&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Vitreous Retina Macula Consultants of New York</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Mennel S, Meyer CH, Callizo J. Combined intravitreal anti-vascular endothelial growth factor (Avastin) and photodynamic therapy to treat retinal juxtapapillary capillary haemangioma. Acta Ophthalmol. 2010 Aug;88(5):610-3. doi: 10.1111/j.1755-3768.2008.01449.x. Epub 2009 Feb 12.</citation>
    <PMID>19222401</PMID>
  </reference>
  <reference>
    <citation>Baba T, Kitahashi M, Kubota-Taniai M, Oshitari T, Yamamoto S. Subretinal hemorrhage after photodynamic therapy for juxtapapillary retinal capillary hemangioma. Case Rep Ophthalmol. 2011 Apr 22;2(1):134-9. doi: 10.1159/000328384.</citation>
    <PMID>21589848</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</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>Hemangioma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aflibercept</mesh_term>
  </intervention_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/NCT01714115
org study id: Slakter 1234
nct id: NCT01714115
lead sponsor: 
collaborator: 
This is a single patient investigative treatment study. The patient was diagnosed with a
      retinal tumor in one eye. In the last 2 years, the patient has been treated with all
      available and conventional therapies, including intraocular injections of Avastin and
      Lucentis, steroids, and photodynamic therapy. Any positive results were short-term, and
      caused an eventual decline in central vision. Aflibercept has been shown to be effective
      against the growth of new vessels, secondary to macular degeneration. This study proposes
      that it may also be more effective in treating this particular patient and case. The study
      treatment plan is for 6 months initially, with the intention to continue treatment.
The treatment plan will be to administer aflibercept 2.0 mg intravitreally every two to four
      weeks for at least six consecutive injections. Prior to initiation of therapy and at each
      study visit, a full ophthalmic examination, best-corrected visual acuity, and a complete
      review of systems to monitor for any toxicity will be performed. In addition, the
      investigators will perform fluorescein and indocyanine green angiography at baseline and
      obtain color fundus photographs as well as spectral domain OCT images to properly document
      the extent and degree of activity of the vascular tumor at baseline and at all study visits.
intervention type: Drug
intervention name: Aflibercept
description: 2.0 mg Intravitreal Injection, every 2 to 4 weeks
other name: Eylea, VEGF Trap-Eye
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
facility: 
country: United States
citation: Mennel S, Meyer CH, Callizo J. Combined intravitreal anti-vascular endothelial growth factor (Avastin) and photodynamic therapy to treat retinal juxtapapillary capillary haemangioma. Acta Ophthalmol. 2010 Aug;88(5):610-3. doi: 10.1111/j.1755-3768.2008.01449.x. Epub 2009 Feb 12.
PMID: 19222401
citation: Baba T, Kitahashi M, Kubota-Taniai M, Oshitari T, Yamamoto S. Subretinal hemorrhage after photodynamic therapy for juxtapapillary retinal capillary hemangioma. Case Rep Ophthalmol. 2011 Apr 22;2(1):134-9. doi: 10.1159/000328384.
PMID: 21589848
responsible party type: Sponsor
mesh term: Hemangioma
mesh term: Aflibercept