<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/NCT03238157</url>
  </required_header>
  <id_info>
    <org_study_id>NDA 201923</org_study_id>
    <nct_id>NCT03238157</nct_id>
  </id_info>
  <brief_title>Steroids for Early Treatment of Radiation Retinopathy</brief_title>
  <official_title>Steroids for Early Treatment of Radiation Retinopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Radiation retinopathy is a known complication of ocular radiation therapy. To date there is&#xD;
      no known effective treatment. In addition to their anti-vascular endothelial growth factor&#xD;
      (VEGF) properties, corticosteroids decrease the retinal capillary permeability by increasing&#xD;
      the activity/density of tight junctions and acute inflammatory effects of radiation in&#xD;
      various tissues.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the project is threefold:&#xD;
&#xD;
        1. To study the natural history of radiation retinopathy using advanced imaging techniques.&#xD;
           A combination of macular OCT to evaluate for edema, OCT angiography to evaluate for&#xD;
           macular and peri-papillary ischemia and wide-field angiography for peripheral ischemia&#xD;
           and leakage. Potential role of OCT angiography in radiation retinopathy will be&#xD;
           evaluated by comparison to other eye (control) and FA.&#xD;
&#xD;
        2. Currently there is no consensus on effective management strategy for radiation&#xD;
           retinopathy. Patients in the interventional will be prospectively followed to study&#xD;
           efficacy of steroids for early treatment of radiation retinopathy while comparing the&#xD;
           multimodal therapeutic approach in a randomized trial.&#xD;
&#xD;
        3. Patients in the observational arm will be prospectively followed while comparing the&#xD;
           multimodal therapeutic approach in a randomized trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of funding&#xD;
  </why_stopped>
  <start_date type="Anticipated">February 1, 2022</start_date>
  <completion_date type="Anticipated">September 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2022</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized to either observation (2:1) (standard of care) or intravitreal Fluocinolone Acetonide (FA) implant</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Central subfield retinal thickness by OCT scan</measure>
    <time_frame>24 months</time_frame>
    <description>Anatomic outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Best corrected visual acuity</measure>
    <time_frame>24 months</time_frame>
    <description>Functional outcome Best corrected Visual acuity and Visual field defect</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Need for standard of care intervention</measure>
    <time_frame>24 months</time_frame>
    <description>standard of care intervention with laser photocoagulation and/ or anti VEGF agents</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Radiation Retinopathy</condition>
  <arm_group>
    <arm_group_label>Observation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The study will only include those patients that are ascertained be at more than 50% risk for vision loss (20/200 or worse at 3 years) because of total radiation dose of &gt;40 Gy to the center of the macula. These &quot;at risk&quot; patients included in the study will receive intravitreal triamcinolone (4 mg in 0.1 ml) injected at the time of plaque removal. If lack of IOP rise (30 mm Hg or more) at 3 months, then randomized to either observation (2:1) (standard of care).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The study will only include those patients that are ascertained be at more than 50% risk for vision loss (20/200 or worse at 3 years) because of total radiation dose of &gt;40 Gy to the center of the macula.1 These &quot;at risk&quot; patients included in the study will receive intravitreal triamcinolone (4 mg in 0.1 ml) injected at the time of plaque removal. If lack of IOP rise (30 mm Hg or more) at 3 months, then randomized to intravitreal Fluocinolone Acetonide (FA) implant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluocinolone Acetonide (FA) implant</intervention_name>
    <description>Fluocinolone Acetonide (FA) implant is designed to release FA at an initial rate of approximately 0.6 g/d, decreasing over the first month to a steady rate of 0.3 to 0.4 g/d with a duration of approximately 30 months.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Steroid</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary uveal melanoma&#xD;
&#xD;
          -  Primary treatment with plaque brachytherapy&#xD;
&#xD;
          -  Baseline visual acuity 20/200 or better&#xD;
&#xD;
          -  Posterior tumor margin &gt;1.50 mm from the center of the macula&#xD;
&#xD;
          -  Posterior tumor margin &gt; 1.50 mm from the closest disc margin&#xD;
&#xD;
          -  Calculated total dose to center of the macula &gt;40 Gy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Iris melanoma&#xD;
&#xD;
          -  Opaque media&#xD;
&#xD;
          -  less than 21 years of age&#xD;
&#xD;
          -  Inability to give consent&#xD;
&#xD;
          -  Positive pregnancy test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cole Eye Instiute</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>August 2, 2021</last_update_submitted>
  <last_update_submitted_qc>August 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Arun SINGH</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluocinolone Acetonide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03238157
org study id: NDA 201923
nct id: NCT03238157
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Radiation retinopathy is a known complication of ocular radiation therapy. To date there is
      no known effective treatment. In addition to their anti-vascular endothelial growth factor
      (VEGF) properties, corticosteroids decrease the retinal capillary permeability by increasing
      the activity/density of tight junctions and acute inflammatory effects of radiation in
      various tissues.
The purpose of the project is threefold:

        1. To study the natural history of radiation retinopathy using advanced imaging techniques.
           A combination of macular OCT to evaluate for edema, OCT angiography to evaluate for
           macular and peri-papillary ischemia and wide-field angiography for peripheral ischemia
           and leakage. Potential role of OCT angiography in radiation retinopathy will be
           evaluated by comparison to other eye (control) and FA.

        2. Currently there is no consensus on effective management strategy for radiation
           retinopathy. Patients in the interventional will be prospectively followed to study
           efficacy of steroids for early treatment of radiation retinopathy while comparing the
           multimodal therapeutic approach in a randomized trial.

        3. Patients in the observational arm will be prospectively followed while comparing the
           multimodal therapeutic approach in a randomized trial.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized to either observation (2:1) (standard of care) or intravitreal Fluocinolone Acetonide (FA) implant
primary purpose: Treatment
masking: None (Open Label)
measure: Central subfield retinal thickness by OCT scan
time frame: 24 months
description: Anatomic outcome
measure: Best corrected visual acuity
time frame: 24 months
description: Functional outcome Best corrected Visual acuity and Visual field defect
measure: Need for standard of care intervention
time frame: 24 months
description: standard of care intervention with laser photocoagulation and/ or anti VEGF agents
arm group label: Observation
arm group type: No Intervention
description: The study will only include those patients that are ascertained be at more than 50% risk for vision loss (20/200 or worse at 3 years) because of total radiation dose of >40 Gy to the center of the macula. These "at risk" patients included in the study will receive intravitreal triamcinolone (4 mg in 0.1 ml) injected at the time of plaque removal. If lack of IOP rise (30 mm Hg or more) at 3 months, then randomized to either observation (2:1) (standard of care).
arm group label: Intervention
arm group type: Active Comparator
description: The study will only include those patients that are ascertained be at more than 50% risk for vision loss (20/200 or worse at 3 years) because of total radiation dose of >40 Gy to the center of the macula.1 These "at risk" patients included in the study will receive intravitreal triamcinolone (4 mg in 0.1 ml) injected at the time of plaque removal. If lack of IOP rise (30 mm Hg or more) at 3 months, then randomized to intravitreal Fluocinolone Acetonide (FA) implant.
intervention type: Drug
intervention name: Fluocinolone Acetonide (FA) implant
description: Fluocinolone Acetonide (FA) implant is designed to release FA at an initial rate of approximately 0.6 g/d, decreasing over the first month to a steady rate of 0.3 to 0.4 g/d with a duration of approximately 30 months.
arm group label: Intervention
other name: Steroid
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Arun SINGH
investigator title: Professor
mesh term: Retinal Diseases
mesh term: Fluocinolone Acetonide
sharing ipd: Undecided