<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/NCT02980874</url>
  </required_header>
  <id_info>
    <org_study_id>CLS1003-301</org_study_id>
    <nct_id>NCT02980874</nct_id>
  </id_info>
  <brief_title>Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO</brief_title>
  <acronym>SAPPHIRE</acronym>
  <official_title>SAPPHIRE: A Randomized, Masked, Controlled Trial To Study The Safety And Efficacy Of Suprachoroidal CLS-TA In Conjunction With Intravitreal Aflibercept In Subjects With Retinal Vein Occlusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clearside Biomedical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clearside Biomedical, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12&#xD;
      months duration in treatment naïve subjects with RVO.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal&#xD;
      CLS-TA in conjunction with intravitreal aflibercept in subjects with retinal vein occlusion&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Primary, 8-week efficacy endpoint not achieved. No additional benefit for subjects receiving a&#xD;
    corticosteroid together with an intravitreal anti-VEGF agent.&#xD;
  </why_stopped>
  <start_date type="Actual">January 31, 2017</start_date>
  <completion_date type="Actual">December 10, 2018</completion_date>
  <primary_completion_date type="Actual">December 10, 2018</primary_completion_date>
  <phase>Phase 3</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>Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)</measure>
    <time_frame>2 months</time_frame>
    <description>Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Best Corrected Visual Acuity</measure>
    <time_frame>6 months</time_frame>
    <description>Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Central Subfield Thickness</measure>
    <time_frame>6 months</time_frame>
    <description>Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">460</enrollment>
  <condition>Macular Edema</condition>
  <condition>Retinal Vein Occlusion</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IVT aflibercept (2 mg/0.05 mL) + sham SC procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>suprachoroidal CLS-TA</intervention_name>
    <description>suprachoroidal injection of CLS-TA</description>
    <arm_group_label>Active</arm_group_label>
    <other_name>Triamcinolone acetonide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>suprachoroidal sham</intervention_name>
    <description>suprachoroidal sham procedure</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IVT aflibercept</intervention_name>
    <description>2 mg intravitreal injection of aflibercept</description>
    <arm_group_label>Active</arm_group_label>
    <arm_group_label>Control</arm_group_label>
    <other_name>Aflibercept</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has a clinical diagnosis of RVO in the study eye&#xD;
&#xD;
          -  Has a CST of ≥ 300 µm in the study eye&#xD;
&#xD;
          -  Has an ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye;&#xD;
&#xD;
          -  Is naïve to local pharmacologic treatment for RVO in the study eye;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any active ocular disease or infection in the study eye other than RVO&#xD;
&#xD;
          -  History of glaucoma, intraocular pressure &gt; 21 mmHg or ocular hypertension requiring&#xD;
             more than one medication&#xD;
&#xD;
          -  Any uncontrolled systemic disease that, in the opinion of the Investigator, would&#xD;
             preclude participation in the study&#xD;
&#xD;
          -  Any evidence of neovascularization in the study eye&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Ciulla, MD MBA</last_name>
    <role>Study Director</role>
    <affiliation>Clearside Biomedical, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Associated Retina Consultants, Ltd.</name>
      <address>
        <city>Peoria</city>
        <state>Arizona</state>
        <zip>85381</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retinal Consultants of Arizona and Retinal Research Institute</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85014-2709</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Retina and Vitreous Consultants</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associated Retina Consultants, Ltd.</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85381</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Centers P.C.</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Retina Research Consultants</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Vitreous Medical Group Clinical Research</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211-1841</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlantis Eyecare</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92647</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jacobs Retina Center at the Shiley Eye Institute, UCSD</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern California Retina Vitreous Associates</name>
      <address>
        <city>Mountain View</city>
        <state>California</state>
        <zip>94040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Bay Retina Consultants Inc.</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>95409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Desert Retina Consultants</name>
      <address>
        <city>Palm Desert</city>
        <state>California</state>
        <zip>92211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Institute of California</name>
      <address>
        <city>Palm Desert</city>
        <state>California</state>
        <zip>92260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants San Diego</name>
      <address>
        <city>Poway</city>
        <state>California</state>
        <zip>92064-2526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orange County Retina Medical Group</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Retina Consultants CRC</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay Area Retina Associates</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94599</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>New England Retina Associates</name>
      <address>
        <city>Hamden</city>
        <state>Connecticut</state>
        <zip>06518</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedEye Associates</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143-5188</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Specialty Institute</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Vitreous Associates of Florida</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarasota Retina Institute</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</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>Emory Eye Center</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</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>Marietta Eye Clinic</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants of Hawaii</name>
      <address>
        <city>'Aiea</city>
        <state>Hawaii</state>
        <zip>96701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois Eye and Ear Infirmary, UIC</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois Retina Associates</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60657</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Foundation Hospital</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Eye Institute</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46290</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Associates, PA</name>
      <address>
        <city>Shawnee Mission</city>
        <state>Kansas</state>
        <zip>66204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina and Vitrous Associates of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilmer Eye Institute John Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287-0005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cumberland Valley Retina Consultants</name>
      <address>
        <city>Hagerstown</city>
        <state>Maryland</state>
        <zip>21740-5940</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Retina Institute</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Associates of NJ</name>
      <address>
        <city>Teaneck</city>
        <state>New Jersey</state>
        <zip>07666</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Carolina Retinal Associates, PA</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Eye Institute</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation/Cole Eye Institute</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Retina Institute</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Casey Eye Institute/Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eye Care Specialists</name>
      <address>
        <city>Kingston</city>
        <state>Pennsylvania</state>
        <zip>18704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wills Eye Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</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>57701-7374</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Research Institute of Texas</name>
      <address>
        <city>Abilene</city>
        <state>Texas</state>
        <zip>79606-1224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Retina Associates-Arlington</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76012-2505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Retina Associates</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Retina Associates</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants of Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Retina Institute</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>78240-1502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants of Houston</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77384</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah HSC - John A. Moran Eye Center</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Institute of Virginia</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Retina Center</name>
      <address>
        <city>Warrenton</city>
        <state>Virginia</state>
        <zip>20186</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin-Madison</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strathfield Retina Clinic</name>
      <address>
        <city>Strathfield</city>
        <state>New South Wales</state>
        <zip>2135</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Save Site Institute, University of Sydney, Sydney Eye Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sydney Retina Clinic and Day Surgery</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marsden Eye Specialists</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2150</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Victorian Eye and Ear Hospital</name>
      <address>
        <city>East Melbourne</city>
        <state>Victoria</state>
        <zip>3002</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialist Eye Group</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3150</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Graz-Department of Ophthalmology</name>
      <address>
        <city>Graz</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kepler University Hospital</name>
      <address>
        <city>Linz</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UBC/VGH Eye Care Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 3N9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Health Care London, Ivey Eye Institute</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4V2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Ottawa Eye Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de l'oeil des Laurentides</name>
      <address>
        <city>Boisbriand</city>
        <state>Quebec</state>
        <zip>J7H 1S6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CIUSSS de l'Est-de-l'Ile-de-Montreal. Hospital Maisonneuve-Rosemont, Comite d'ethique de la recherche</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Glostrup</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept. of Ophthalmology, Sjællands Universitetshospital, Roskilde</name>
      <address>
        <city>Roskilde</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Semmelweis Egyetem, Szemeszeti Klinika</name>
      <address>
        <city>Budapest</city>
        <zip>1083</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bajcsy-Zsilinszky Korhaz es Rendelointezet, Szemeszeti Osztaly</name>
      <address>
        <city>Budapest</city>
        <zip>1106</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magyar Honvedseg Egeszsegugyi Kozpont</name>
      <address>
        <city>Budapest</city>
        <zip>1162</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Budapest Retina Associates</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Klinikai Kozpont, Szemklinika</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ganglion Orvosi Kozpont</name>
      <address>
        <city>Pecs</city>
        <zip>7621</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M&amp;J Western Regional Institute of Ophthalmology</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380016</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>T.N. Medical College and B.Y.L. Nair Charitable Hospital</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400008</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Medical Ophthalmology, Retina &amp; Uvea</name>
      <address>
        <city>Delhi</city>
        <state>New Delhi</state>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aravind Eye Hospitals &amp; Postgraduate Institute of Ophthalmology</name>
      <address>
        <city>Madurai</city>
        <state>Tamil Nadu</state>
        <zip>625020</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Smt. Kanuri Santhamma Centre for Vitreo Retinal Diseases</name>
      <address>
        <city>Hyderabad</city>
        <state>Telangana</state>
        <zip>500034</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Disha Eye Hospital Private Limited</name>
      <address>
        <city>Kolkata</city>
        <state>West Bengal</state>
        <zip>700120</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bnai Zion Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>3104802</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Fatebenefratelli Sacco - P.O.L., University of Milan, Dep. of Ophthalmology</name>
      <address>
        <city>Milan</city>
        <zip>20157</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cebu Doctor's University Hospital</name>
      <address>
        <city>Cebu City</city>
        <zip>6000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peregrine Eye &amp; Laser Institute</name>
      <address>
        <city>Makati City</city>
        <zip>1209</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Medical City</name>
      <address>
        <city>Pasig City</city>
        <zip>1600</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oftalmika sp. z o. o.</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-631</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Optimum Profesorskie Centrum Okulistyki</name>
      <address>
        <city>Gdansk</city>
        <zip>80-809</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersytet Medyczny w Lublinie</name>
      <address>
        <city>Lublin</city>
        <zip>20-079</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Diagnostyki i Mikrochirurgii Oka Lens</name>
      <address>
        <city>Olsztyn</city>
        <zip>10-424</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Clinico Academico Braga - 2CA-Braga</name>
      <address>
        <city>Braga</city>
        <zip>4710-243</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar e Universitario de Coimbra, E.P.E.</name>
      <address>
        <city>Coimbra</city>
        <zip>3000-075</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar de Sao Joao, E.P.E.</name>
      <address>
        <city>Porto</city>
        <zip>4200-319</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultna nemocnica s poliklinikou Zilina</name>
      <address>
        <city>Žilina</city>
        <zip>01207</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Cinico Quirurgico de Oftalmologia</name>
      <address>
        <city>Bilbao</city>
        <state>Vizcaya</state>
        <zip>48006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Catalunya</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari de Bellvitge</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Oftalmologico Fernandez-Vega</name>
      <address>
        <city>Oviedo</city>
        <zip>33012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universidad de Navarra</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario</name>
      <address>
        <city>Zaragoza</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Veterans General Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>81362</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queens University Royal Victoria Hospital Trust</name>
      <address>
        <city>Belfast</city>
        <zip>BT12 6BJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunderland Eye Infirmary</name>
      <address>
        <city>Sunderland</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Philippines</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <results_first_submitted>March 18, 2021</results_first_submitted>
  <results_first_submitted_qc>March 18, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 14, 2021</results_first_posted>
  <disposition_first_submitted>December 13, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>December 13, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 17, 2019</disposition_first_posted>
  <last_update_submitted>March 18, 2021</last_update_submitted>
  <last_update_submitted_qc>March 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>RVO</keyword>
  <keyword>ME</keyword>
  <keyword>Central Subfield Thickness</keyword>
  <keyword>OCT</keyword>
  <keyword>Optical Coherence Tomography</keyword>
  <keyword>Cystoid Macular Edema</keyword>
  <keyword>Subretinal Fluid</keyword>
  <keyword>Eylea</keyword>
  <keyword>Aflibercept</keyword>
  <keyword>Anti-VEGF</keyword>
  <keyword>Suprachoroidal</keyword>
  <keyword>Triamcinolone acetonide</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Edema</mesh_term>
    <mesh_term>Retinal Vein Occlusion</mesh_term>
    <mesh_term>Edema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triamcinolone</mesh_term>
    <mesh_term>Triamcinolone Acetonide</mesh_term>
    <mesh_term>Triamcinolone hexacetonide</mesh_term>
    <mesh_term>Aflibercept</mesh_term>
    <mesh_term>Triamcinolone diacetate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 31, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT02980874/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Active</title>
          <description>IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections&#xD;
suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA&#xD;
IVT aflibercept: 2 mg intravitreal injection of aflibercept</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>IVT aflibercept (2 mg/0.05 mL) + sham SC procedure&#xD;
suprachoroidal sham: suprachoroidal sham procedure&#xD;
IVT aflibercept: 2 mg intravitreal injection of aflibercept</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="231"/>
                <participants group_id="P2" count="229"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="128"/>
                <participants group_id="P2" count="127"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="103"/>
                <participants group_id="P2" count="102"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Includes premature discontinuation due to study termination.</title>
              <participants_list>
                <participants group_id="P1" count="88"/>
                <participants group_id="P2" count="88"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unknown study completion status</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Safety population included all randomly assigned subjects who were administered at least one dose of the study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Active</title>
          <description>IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections&#xD;
suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA&#xD;
IVT aflibercept: 2 mg intravitreal injection of aflibercept</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>IVT aflibercept (2 mg/0.05 mL) + sham SC procedure&#xD;
suprachoroidal sham: suprachoroidal sham procedure&#xD;
IVT aflibercept: 2 mg intravitreal injection of aflibercept</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="231"/>
            <count group_id="B2" value="229"/>
            <count group_id="B3" value="460"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Age of patients in years relative to the date of the Screening visit.</description>
          <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="89"/>
                    <measurement group_id="B2" value="107"/>
                    <measurement group_id="B3" value="196"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="142"/>
                    <measurement group_id="B2" value="122"/>
                    <measurement group_id="B3" value="264"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <description>Age of patients in years relative to the date of the Screening visit.</description>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.4" spread="12.31"/>
                    <measurement group_id="B2" value="64.9" spread="12.42"/>
                    <measurement group_id="B3" value="65.7" spread="12.37"/>
                  </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="97"/>
                    <measurement group_id="B2" value="105"/>
                    <measurement group_id="B3" value="202"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="134"/>
                    <measurement group_id="B2" value="124"/>
                    <measurement group_id="B3" value="258"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="181"/>
                    <measurement group_id="B2" value="177"/>
                    <measurement group_id="B3" value="358"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </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>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="182"/>
                    <measurement group_id="B2" value="183"/>
                    <measurement group_id="B3" value="365"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Philippines</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Portugal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>India</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taiwan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Denmark</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slovakia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of Retinal Vein Occlusion</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Branch retinal vein occlusion</title>
                  <measurement_list>
                    <measurement group_id="B1" value="124"/>
                    <measurement group_id="B2" value="124"/>
                    <measurement group_id="B3" value="248"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Central retinal vein occlusion</title>
                  <measurement_list>
                    <measurement group_id="B1" value="107"/>
                    <measurement group_id="B2" value="105"/>
                    <measurement group_id="B3" value="212"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)</title>
        <description>Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.</description>
        <time_frame>2 months</time_frame>
        <population>The Intent-to-treat population included all randomized subjects who received at least one study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Active</title>
            <description>IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections&#xD;
suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA&#xD;
IVT aflibercept: 2 mg intravitreal injection of aflibercept</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>IVT aflibercept (2 mg/0.05 mL) + sham SC procedure&#xD;
suprachoroidal sham: suprachoroidal sham procedure&#xD;
IVT aflibercept: 2 mg intravitreal injection of aflibercept</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)</title>
          <description>Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.</description>
          <population>The Intent-to-treat population included all randomized subjects who received at least one study treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="231"/>
                <count group_id="O2" value="229"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114"/>
                    <measurement group_id="O2" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Based on a Pearson chi-square test, a total sample size of approximately 460 subjects provided 90% power to detect a difference of 15% between the Active and Control arms assuming the Control arm showed a proportion of 0.50 at 8 weeks. The primary analysis was a test of superiority of the Active arm over the Control arm, and was based on a Cochran-Mantel-Haenszel chi-square test stratified by type of retinal vein occlusion.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.187</p_value>
            <p_value_desc>The a priori threshold for statistical significance was 0.050. Prior to evaluating the results of the CMH test, a Breslow-Day test with Tarone's adjustment was conducted to confirm the homogeneity of the odds ratios between RVO strata.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <method_desc>The CMH test was stratified by the type of retinal vein occlusion, i.e., branch vs. central.</method_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>-6.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.2</ci_lower_limit>
            <ci_upper_limit>3.0</ci_upper_limit>
            <estimate_desc>Estimated value was calculated as the percentage of subjects in the Active arm meeting the primary endpoint minus the percentage of subjects in the Control arm meeting the primary endpoint.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Best Corrected Visual Acuity</title>
        <description>Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision.</description>
        <time_frame>6 months</time_frame>
        <population>The Intent-to-treat population included all randomized subjects who received at least one study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Active</title>
            <description>IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections&#xD;
suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA&#xD;
IVT aflibercept: 2 mg intravitreal injection of aflibercept</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>IVT aflibercept (2 mg/0.05 mL) + sham SC procedure&#xD;
suprachoroidal sham: suprachoroidal sham procedure&#xD;
IVT aflibercept: 2 mg intravitreal injection of aflibercept</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Best Corrected Visual Acuity</title>
          <description>Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision.</description>
          <population>The Intent-to-treat population included all randomized subjects who received at least one study treatment.</population>
          <units>Letters</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="231"/>
                <count group_id="O2" value="229"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.5" spread="0.85"/>
                    <measurement group_id="O2" value="20.5" spread="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Central Subfield Thickness</title>
        <description>Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema.</description>
        <time_frame>6 months</time_frame>
        <population>The Intent-to-treat population included all randomized subjects who received at least one study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Active</title>
            <description>IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections&#xD;
suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA&#xD;
IVT aflibercept: 2 mg intravitreal injection of aflibercept</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>IVT aflibercept (2 mg/0.05 mL) + sham SC procedure&#xD;
suprachoroidal sham: suprachoroidal sham procedure&#xD;
IVT aflibercept: 2 mg intravitreal injection of aflibercept</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Central Subfield Thickness</title>
          <description>Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema.</description>
          <population>The Intent-to-treat population included all randomized subjects who received at least one study treatment.</population>
          <units>Microns</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="231"/>
                <count group_id="O2" value="210"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-354.3" spread="8.01"/>
                    <measurement group_id="O2" value="-416.2" spread="8.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected over 48 weeks of follow-up.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Active</title>
          <description>IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections&#xD;
suprachoroidal CLS-TA: suprachoroidal injection of CLS-TA&#xD;
IVT aflibercept: 2 mg intravitreal injection of aflibercept</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>IVT aflibercept (2 mg/0.05 mL) + sham SC procedure&#xD;
suprachoroidal sham: suprachoroidal sham procedure&#xD;
IVT aflibercept: 2 mg intravitreal injection of aflibercept</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (19.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="231"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <description>#Fellow eye</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <description>#Study eye</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Ulcerative keratitis</sub_title>
                <description>#Study eye</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Visual acuity reduced</sub_title>
                <description>#Study eye</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Vitreous haemorrhage</sub_title>
                <description>#Study eye</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Large intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Abasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis perforated</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Colonic abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Empyema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Endophthalmitis</sub_title>
                <description>#Study eye</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Hepatitis C</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Perirectal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Alcohol poisoning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Facial bones fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Multiple fractures</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Pelvic fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Sternal fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Intraocular pressure increased</sub_title>
                <description>#Study eye</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Lactic acidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rotor cuff syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Ovarian cancer metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Paraganglion neoplasm malignant</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Coma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Hemiplegia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Transient global amnesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Prostatomegaly</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Pulmonary congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic arteriosclerosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="231"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="231"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (19.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="128" subjects_at_risk="231"/>
                <counts group_id="E2" subjects_affected="83" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="29" subjects_affected="21" subjects_at_risk="231"/>
                <counts group_id="E2" events="12" subjects_affected="9" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Cataract subcapsular</sub_title>
                <counts group_id="E1" events="22" subjects_affected="20" subjects_at_risk="231"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" events="65" subjects_affected="42" subjects_at_risk="231"/>
                <counts group_id="E2" events="31" subjects_affected="28" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" events="24" subjects_affected="20" subjects_at_risk="231"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Macular oedema</sub_title>
                <counts group_id="E1" events="11" subjects_affected="8" subjects_at_risk="231"/>
                <counts group_id="E2" events="16" subjects_affected="13" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Visual acuity reduced</sub_title>
                <counts group_id="E1" events="18" subjects_affected="16" subjects_at_risk="231"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Vitreous detachment</sub_title>
                <counts group_id="E1" events="16" subjects_affected="13" subjects_at_risk="231"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="231"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Intraocular pressure increased</sub_title>
                <counts group_id="E1" events="51" subjects_affected="33" subjects_at_risk="231"/>
                <counts group_id="E2" events="13" subjects_affected="9" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="18" subjects_affected="15" subjects_at_risk="231"/>
                <counts group_id="E2" events="17" subjects_affected="15" subjects_at_risk="229"/>
              </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>The institutions and Investigators participating in this study shall have no right to publish or present the results of this study without the prior written consent of Clearside Biomedical, Inc.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Due to the early termination of the trial by sponsor all planned study visits were not completed by all treated subjects; therefore, all planned data was not collected.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Thomas Ciulla, MD MBA</name_or_title>
      <organization>Clearside Biomedical, Inc.</organization>
      <phone>(678) 392-2318</phone>
      <email>thomas.ciulla@clearsidebio.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/NCT02980874
org study id: CLS1003-301
nct id: NCT02980874
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12
      months duration in treatment naïve subjects with RVO.
A randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal
      CLS-TA in conjunction with intravitreal aflibercept in subjects with retinal vein occlusion
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS)
time frame: 2 months
description: Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.
measure: Mean Change From Baseline in Best Corrected Visual Acuity
time frame: 6 months
description: Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision.
measure: Mean Change From Baseline in Central Subfield Thickness
time frame: 6 months
description: Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema.
arm group label: Active
arm group type: Experimental
description: IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections
arm group label: Control
arm group type: Active Comparator
description: IVT aflibercept (2 mg/0.05 mL) + sham SC procedure
intervention type: Drug
intervention name: suprachoroidal CLS-TA
description: suprachoroidal injection of CLS-TA
arm group label: Active
other name: Triamcinolone acetonide
intervention type: Drug
intervention name: suprachoroidal sham
description: suprachoroidal sham procedure
arm group label: Control
intervention type: Drug
intervention name: IVT aflibercept
description: 2 mg intravitreal injection of aflibercept
arm group label: Active
arm group label: Control
other name: Aflibercept
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Ciulla, MD MBA
role: Study Director
affiliation: Clearside Biomedical, Inc.
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country: Australia
country: Austria
country: Canada
country: Denmark
country: Hungary
country: India
country: Israel
country: Italy
country: Philippines
country: Poland
country: Portugal
country: Slovakia
country: Spain
country: Taiwan
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Macular Edema
mesh term: Retinal Vein Occlusion
mesh term: Edema
mesh term: Triamcinolone
mesh term: Triamcinolone Acetonide
mesh term: Triamcinolone hexacetonide
mesh term: Aflibercept
mesh term: Triamcinolone diacetate
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to the early termination of the trial by sponsor all planned study visits were not completed by all treated subjects; therefore, all planned data was not collected.
point of contact: 