<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/NCT04429139</url>
  </required_header>
  <id_info>
    <org_study_id>2011MEKY0015</org_study_id>
    <nct_id>NCT04429139</nct_id>
  </id_info>
  <brief_title>Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study</brief_title>
  <official_title>Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To study the effectiveness and safety profiles of photodynamic therapy (PDT) for the&#xD;
      treatment of human retinoblastoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Retinoblastoma is the commonest primary intraocular malignancy in infancy and early&#xD;
      childhood. Ophthalmologist are trying to seek other more safe and effective treatment&#xD;
      modalities to well control the tumor and preserve the visual function. Photodynamic therapy&#xD;
      (PDT) is a potentially therapeutic approach for retinoblastoma which has been underestimated.&#xD;
      In this study, we are gonging to investigate the the effectiveness and safety profiles of&#xD;
      photodynamic therapy (PDT) for the treatment of human retinoblastoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2011</start_date>
  <completion_date type="Actual">May 30, 2020</completion_date>
  <primary_completion_date type="Actual">May 30, 2018</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>eye enucleation</measure>
    <time_frame>3 years</time_frame>
    <description>the rate of eye enucleation of patients with retinoblastoma in different groups</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Retinoblastoma</condition>
  <arm_group>
    <arm_group_label>PDT treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All the patients received once PDT with Visudyne® as the initial treatment. Rescue treatment with systemic chemotherapy would be given to patients if tumors were insensitive to PDT treatment, the tumors became larger, or disease relapse.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>photodynamic therapy</intervention_name>
    <description>PDT with Visudyne® was performed under general anesthesia according to the standard TAP study with some modifications: Verteporfin (6 mg/m2, Visudyne®; Novartis International AG, Basel, Switzerland) was injected intravenously with a standard 10-min infusion followed by followed by application of diode laser (Opal Photoactivator; Coherent Medical Group, Santa Clara, USA) (689 nm, 50 J/cm2, 600 mW/cm2) for 200 seconds to generate 120 J/cm2.</description>
    <arm_group_label>PDT treatment group</arm_group_label>
    <other_name>systemic chemotherapy</other_name>
    <other_name>Laser photocoagulation</other_name>
    <other_name>Cryotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with intraocular retinoblastoma of Group A-D&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) patients with intraocular retinoblastoma of group E; (2) patients with extraocular&#xD;
             spread; (3); media opacities such as corneal opacity, significant cataract, or&#xD;
             vitreous hemorrhage obscuring fundus examination; (4) patients who were allergic to&#xD;
             verteporfin or other benzoporphyrin derivatives.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kunbei Lai</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Jin Chen-jin</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <keyword>Photodynamic therapy</keyword>
  <keyword>Retinoblastoma</keyword>
  <keyword>Visudyne</keyword>
  <keyword>Verteporfin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinoblastoma</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/NCT04429139
org study id: 2011MEKY0015
nct id: NCT04429139
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
To study the effectiveness and safety profiles of photodynamic therapy (PDT) for the
      treatment of human retinoblastoma.
Retinoblastoma is the commonest primary intraocular malignancy in infancy and early
      childhood. Ophthalmologist are trying to seek other more safe and effective treatment
      modalities to well control the tumor and preserve the visual function. Photodynamic therapy
      (PDT) is a potentially therapeutic approach for retinoblastoma which has been underestimated.
      In this study, we are gonging to investigate the the effectiveness and safety profiles of
      photodynamic therapy (PDT) for the treatment of human retinoblastoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: eye enucleation
time frame: 3 years
description: the rate of eye enucleation of patients with retinoblastoma in different groups
arm group label: PDT treatment group
arm group type: Experimental
description: All the patients received once PDT with Visudyne® as the initial treatment. Rescue treatment with systemic chemotherapy would be given to patients if tumors were insensitive to PDT treatment, the tumors became larger, or disease relapse.
intervention type: Drug
intervention name: photodynamic therapy
description: PDT with Visudyne® was performed under general anesthesia according to the standard TAP study with some modifications: Verteporfin (6 mg/m2, Visudyne®; Novartis International AG, Basel, Switzerland) was injected intravenously with a standard 10-min infusion followed by followed by application of diode laser (Opal Photoactivator; Coherent Medical Group, Santa Clara, USA) (689 nm, 50 J/cm2, 600 mW/cm2) for 200 seconds to generate 120 J/cm2.
arm group label: PDT treatment group
other name: systemic chemotherapy
other name: Laser photocoagulation
other name: Cryotherapy
criteria: 
gender: All
minimum age: 1 Year
maximum age: 20 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Jin Chen-jin
investigator title: Prof.
mesh term: Retinoblastoma
sharing ipd: No