<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/NCT01710332</url>
  </required_header>
  <id_info>
    <org_study_id>CSRII</org_study_id>
    <secondary_id>20121564</secondary_id>
    <nct_id>NCT01710332</nct_id>
  </id_info>
  <brief_title>The Safety &amp; Efficacy of Intravitreal Aflibercept Injection in Patients With Persistent Central Serous Chorioretinopathy</brief_title>
  <acronym>CONTAIN</acronym>
  <official_title>Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wills Eye</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Wills Eye</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A preliminary study to determine the safety and efficacy of intravitreal aflibercept&#xD;
      injection in patients with persistent central serous chorioretinopathy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A&#xD;
      Prospective Pilot Study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety of Intravitreal Aflibercept Injection</measure>
    <time_frame>6 months</time_frame>
    <description>Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Vision Based on Letter Score</measure>
    <time_frame>6 months</time_frame>
    <description>• Mean change from baseline in best-corrected ETDRS (Early Treatment of Diabetic Retinopathy Study) letter score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Central Serous Chorioretinopathy</condition>
  <arm_group>
    <arm_group_label>Intravitreal Aflibercept Injection (x4)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravitreal Aflibercept Injection (x6)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravitreal Aflibercept Injection</intervention_name>
    <description>GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).&#xD;
GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).</description>
    <arm_group_label>Intravitreal Aflibercept Injection (x4)</arm_group_label>
    <arm_group_label>Intravitreal Aflibercept Injection (x6)</arm_group_label>
    <other_name>Eylea</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pre-treatment acuity of 20/40- 20/320&#xD;
&#xD;
          -  Macular fluid on optical coherence tomography for greater than 3 months&#xD;
&#xD;
          -  Leakage on fluorescein angiography&#xD;
&#xD;
          -  Willing and able to comply with clinic visits and study-related procedures&#xD;
&#xD;
          -  Provide signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment for CSCR in the study eye (anti-VEGF, PDT, or laser) within three months&#xD;
             prior to study enrollment&#xD;
&#xD;
          -  Presence of choroidal neovascularization on enrollment imaging&#xD;
&#xD;
          -  Prior vitrectomy in the study eye&#xD;
&#xD;
          -  Presence of any substantial ocular disease (other than CSCR) that may compromise&#xD;
             vision in the study eye and /or confound interpretation of the data; e.g. substantial&#xD;
             cataracts, advanced glaucoma, optic neuritis, optic neuropathy or atrophy, marked&#xD;
             macular atrophy, ocular vascular occlusion, history of retinal detachment, uveitis,&#xD;
             viral or other forms of chorioretinitis, etc.&#xD;
&#xD;
          -  History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the&#xD;
             study eye&#xD;
&#xD;
          -  Uncontrolled glaucoma in the study eye (defined as IOP ≥ 25 mmHg despite treatment&#xD;
             with anti-glaucoma medication)&#xD;
&#xD;
          -  Active ocular infection or inflammation in the study eye&#xD;
&#xD;
          -  Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either&#xD;
             eye&#xD;
&#xD;
          -  Prior treatment with systemic anti-VEGF agents&#xD;
&#xD;
          -  Cerebrovascular accident or myocardial infarction within the preceding 6 months.&#xD;
&#xD;
          -  History of allergy to fluorescein, povidone iodine (Betadine) or aflibercept&#xD;
&#xD;
          -  Participation in a study of an investigational drug or device within 30 days prior to&#xD;
             potential enrollment into the study&#xD;
&#xD;
          -  Pregnant or breast-feeding women Sexually active men* or women of childbearing&#xD;
             potential** who are unwilling to practice adequate contraception during the study&#xD;
             (adequate contraceptive measures include stable use of oral contraceptives or other&#xD;
             prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to&#xD;
             screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus&#xD;
             contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or&#xD;
             jelly)&#xD;
&#xD;
               -  Contraception is not required for men with documented vasectomy.&#xD;
&#xD;
                    -  Postmenopausal women must be amenorrheic for at least 12 months in order not&#xD;
                       to be considered of child bearing potential. Pregnancy testing and&#xD;
                       contraception are not required for women with documented hysterectomy or&#xD;
                       tubal ligation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Allen Ho, MD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>Mid Atlantic Retina- Huntingdon Valley</name>
      <address>
        <city>Huntingdon Valley</city>
        <state>Pennsylvania</state>
        <zip>19006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid Atlantic Retna- Wills Eye Institute</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <results_first_submitted>February 22, 2017</results_first_submitted>
  <results_first_submitted_qc>February 22, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 7, 2017</results_first_posted>
  <last_update_submitted>May 22, 2017</last_update_submitted>
  <last_update_submitted_qc>May 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wills Eye</investigator_affiliation>
    <investigator_full_name>Allen C. Ho, MD</investigator_full_name>
    <investigator_title>Investigator</investigator_title>
  </responsible_party>
  <keyword>Persistent</keyword>
  <keyword>Central</keyword>
  <keyword>Serous</keyword>
  <keyword>Chorioretinopathy</keyword>
  <keyword>Regeneron</keyword>
  <keyword>CSR</keyword>
  <keyword>CSCR</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Central Serous Chorioretinopathy</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aflibercept</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intravitreal Aflibercept Injection (x4)</title>
          <description>2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).&#xD;
Intravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).&#xD;
GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).</description>
        </group>
        <group group_id="P2">
          <title>Intravitreal Aflibercept Injection (x6)</title>
          <description>2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).&#xD;
Intravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).&#xD;
GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intravitreal Aflibercept Injection (x4)</title>
          <description>2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).&#xD;
Intravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).&#xD;
GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).</description>
        </group>
        <group group_id="B2">
          <title>Intravitreal Aflibercept Injection (x6)</title>
          <description>2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).&#xD;
Intravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).&#xD;
GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.8" spread="12.8"/>
                    <measurement group_id="B2" value="53.5" spread="9.6"/>
                    <measurement group_id="B3" value="53.7" spread="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Safety of Intravitreal Aflibercept Injection</title>
        <description>Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intravitreal Aflibercept Injection (x4)</title>
            <description>2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).&#xD;
Intravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).</description>
          </group>
          <group group_id="O2">
            <title>Intravitreal Aflibercept Injection (x6)</title>
            <description>2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).&#xD;
GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).</description>
          </group>
        </group_list>
        <measure>
          <title>Safety of Intravitreal Aflibercept Injection</title>
          <description>Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.</description>
          <units>adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Vision Based on Letter Score</title>
        <description>• Mean change from baseline in best-corrected ETDRS (Early Treatment of Diabetic Retinopathy Study) letter score</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intravitreal Aflibercept Injection (x4)</title>
            <description>2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).&#xD;
Intravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).</description>
          </group>
          <group group_id="O2">
            <title>Intravitreal Aflibercept Injection (x6)</title>
            <description>2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).&#xD;
GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Vision Based on Letter Score</title>
          <description>• Mean change from baseline in best-corrected ETDRS (Early Treatment of Diabetic Retinopathy Study) letter score</description>
          <units>ETDRS letters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="12.4"/>
                    <measurement group_id="O2" value="4.7" spread="13.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Intravitreal Aflibercept Injection (x4)</title>
          <description>2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).&#xD;
Intravitreal Aflibercept Injection: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).</description>
        </group>
        <group group_id="E2">
          <title>Intravitreal Aflibercept Injection (x6)</title>
          <description>2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).&#xD;
GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Allen C. Ho, MD</name_or_title>
      <organization>Mid Atlantic Retina</organization>
      <phone>215-459-0477</phone>
      <email>mformoso@midatlanticretina.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01710332
org study id: CSRII
secondary id: 20121564
nct id: NCT01710332
lead sponsor: 
collaborator: 
has dmc: No
A preliminary study to determine the safety and efficacy of intravitreal aflibercept
      injection in patients with persistent central serous chorioretinopathy.
Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A
      Prospective Pilot Study
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety of Intravitreal Aflibercept Injection
time frame: 6 months
description: Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.
measure: Change in Vision Based on Letter Score
time frame: 6 months
description: • Mean change from baseline in best-corrected ETDRS (Early Treatment of Diabetic Retinopathy Study) letter score
arm group label: Intravitreal Aflibercept Injection (x4)
arm group type: Experimental
description: 2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).
arm group label: Intravitreal Aflibercept Injection (x6)
arm group type: Experimental
description: 2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).
intervention type: Drug
intervention name: Intravitreal Aflibercept Injection
description: GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).
GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total).
arm group label: Intravitreal Aflibercept Injection (x4)
arm group label: Intravitreal Aflibercept Injection (x6)
other name: Eylea
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Allen Ho, MD
role: Principal Investigator
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Wills Eye
investigator full name: Allen C. Ho, MD
investigator title: Investigator
mesh term: Central Serous Chorioretinopathy
mesh term: Aflibercept
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 