<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/NCT01694186</url>
  </required_header>
  <id_info>
    <org_study_id>PSV-FAI-001</org_study_id>
    <nct_id>NCT01694186</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert</brief_title>
  <acronym>FAI</acronym>
  <official_title>A Phase III, Multi-National, Multi-Center, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal Insert in Subjects With Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EyePoint Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>EyePoint Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study to evaluate the safety and efficacy of an FAI insert for the management of subjects&#xD;
      with non-infectious uveitis affecting the posterior segment of the eye.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase 3, multi-national, multi-center, randomized, masked, controlled study to&#xD;
      evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal (FAI)&#xD;
      insert for the management of subjects with non-infectious uveitis affecting the posterior&#xD;
      segment of the eye. Patients will be randomized to receive either a sham injection or the FAI&#xD;
      insert and will be observed for three years following treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2, 2013</start_date>
  <completion_date type="Actual">March 26, 2018</completion_date>
  <primary_completion_date type="Actual">March 26, 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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit</measure>
    <time_frame>36 months</time_frame>
    <description>Safety: Ocular adverse events, including IOP elevation; medications/procedures required to control elevated IOP; development or worsening of cataract; cataract-related procedures; clinically significant ocular changes; procedure related adverse events Primary Efficacy Endpoint: Proportion of subjects who have a recurrence of uveitis in the study eye within 6 months after receiving study treatment.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">129</enrollment>
  <condition>Non-Infectious Uveitis</condition>
  <arm_group>
    <arm_group_label>sham injection</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>sham injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FAI insert</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FAI insert (0.18 mg fluocinolone acetonide)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FAI insert</intervention_name>
    <arm_group_label>FAI insert</arm_group_label>
    <other_name>Active Drug</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sham injection</intervention_name>
    <arm_group_label>sham injection</arm_group_label>
    <other_name>Sham Comparator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Male or non-pregnant female at least 18 years of age at time of consent&#xD;
&#xD;
          -  One or both eyes having a history of recurrent non-infectious uveitis affecting the&#xD;
             posterior segment of the eye with or without anterior uveitis &gt; 1 year duration.&#xD;
&#xD;
          -  During the 12 months prior to enrollment (Day 1), the study eye has either received&#xD;
             treatment:&#xD;
&#xD;
          -  systemic corticosteroid or other systemic therapies given for at least 3 months,&#xD;
             and/or&#xD;
&#xD;
          -  at least 2 intra- or peri-ocular injections of corticosteroid for management of&#xD;
             uveitis&#xD;
&#xD;
        OR the study eye has experienced recurrence:&#xD;
&#xD;
          -  at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular&#xD;
             injection of corticosteroid&#xD;
&#xD;
          -  At the time of enrollment (Day 1), study eye has &lt; 10 anterior chamber cells/HPF and a&#xD;
             vitreous haze ≤ grade 2.&#xD;
&#xD;
          -  Visual acuity of study eye is at least 15 letters on the ETDRS chart&#xD;
&#xD;
          -  Subject is not planning to undergo elective ocular surgery during the study&#xD;
&#xD;
          -  Subject has ability to understand and sign the Informed Consent Form&#xD;
&#xD;
          -  Subject is willing and able to comply with scheduled visits, treatment plan,&#xD;
             laboratory tests, and other study procedures&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Allergy to fluocinolone acetonide or any component of the FAI insert&#xD;
&#xD;
          -  History of posterior uveitis only that is not accompanied by vitritis or macular edema&#xD;
&#xD;
          -  History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze&#xD;
&#xD;
          -  Uveitis with infectious etiology&#xD;
&#xD;
          -  Vitreous hemorrhage&#xD;
&#xD;
          -  Intraocular inflammation associated with a condition other than noninfectious uveitis&#xD;
             (e.g. intraocular lymphoma)&#xD;
&#xD;
          -  Ocular malignancy in either eye, including choroidal melanoma&#xD;
&#xD;
          -  Toxoplasmosis scar in study eye; or scar related to previous viral retinitis&#xD;
&#xD;
          -  Previous viral retinitis&#xD;
&#xD;
          -  Current viral diseases of the cornea and conjunctiva including epithelial herpes&#xD;
             simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial&#xD;
             infections of the eye or fungal diseases of ocular structure&#xD;
&#xD;
          -  Media opacity precluding evaluation of retina and vitreous&#xD;
&#xD;
          -  Peripheral retinal detachment in area of insertion&#xD;
&#xD;
          -  Diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening,&#xD;
             unless study eye has been previously treated with an incisional surgery procedure that&#xD;
             has resulted in stable IOP in the normal range (10-21 mmHg)&#xD;
&#xD;
          -  Intraocular pressure (IOP) &gt; 21 mmHg or concurrent therapy at screening with any&#xD;
             IOP-lowering pharmacologic agent in the study eye&#xD;
&#xD;
          -  Chronic hypotony (&lt; 6 mmHg)&#xD;
&#xD;
          -  Ocular surgery on the study eye within 3 months prior to study Day 1&#xD;
&#xD;
          -  Capsulotomy in study eye within 30 days prior to study Day 1&#xD;
&#xD;
          -  Prior intravitreal treatment of study eye with Retisert within 36 months prior to&#xD;
             study Day 1&#xD;
&#xD;
          -  Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study&#xD;
             Day 1&#xD;
&#xD;
          -  Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months&#xD;
             prior to study Day 1&#xD;
&#xD;
          -  Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to&#xD;
             study Day 1&#xD;
&#xD;
          -  Subjects requiring chronic systemic or inhaled corticosteroid therapy (&gt;15mg&#xD;
             prednisone daily) or chronic systemic immunosuppressive therapy&#xD;
&#xD;
          -  Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell&#xD;
             carcinoma), any malignancy receiving treatment, or in remission less than 5 years&#xD;
             prior to study Day 1&#xD;
&#xD;
          -  Subjects who test positive for human immune deficiency virus (HIV) or syphilis during&#xD;
             screening&#xD;
&#xD;
          -  Mycobacterial uveitis or chorio-retinal changes of either eye which, in the opinion of&#xD;
             the Investigator, result from infectious mycobacterial uveitis&#xD;
&#xD;
          -  Systemic infection within 30 days prior to study Day 1&#xD;
&#xD;
          -  Any severe acute or chronic medical or psychiatric condition that could increase the&#xD;
             risk associated with study participation or could interfere with the interpretation of&#xD;
             study results and, in the judgment of the investigator, could make the subject&#xD;
             inappropriate for entry into this study&#xD;
&#xD;
          -  Any other systemic or ocular condition which, in the judgment of the investigator,&#xD;
             could make the subject inappropriate for entry into this study&#xD;
&#xD;
          -  Treatment with an investigational drug or device within 30 days prior to study Day 1&#xD;
&#xD;
          -  Pregnant or nursing females; females of childbearing potential who are unwilling or&#xD;
             unable to use an acceptable method of contraception as outlined in this protocol from&#xD;
             at least 14 days prior to study Day 1 until the Month 12 Visit&#xD;
&#xD;
          -  Subjects unlikely to comply with the study protocol or who are likely to be lost to&#xD;
             follow-up within three years&#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>Glenn Jaffe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University Eye Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Retina Vitreaous Associates</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retinal Consultants Medical Group, Inc</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Macula Institute</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants of Southern Colorado</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmology &amp; Visual Sciences</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ocular Immunology and Uveitis Foundation</name>
      <address>
        <city>Cambridge</city>
        <state>Massachusetts</state>
        <zip>02142</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Consultants</name>
      <address>
        <city>Slingerlands</city>
        <state>New York</state>
        <zip>12159</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Eye Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OHSU Casey Eye Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charleston Neuroscience Institute</name>
      <address>
        <city>Ladson</city>
        <state>South Carolina</state>
        <zip>29456</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Retina Associates</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76012</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>Foresight Studies, LLC</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Augenarzte am St. Franziskus Hospital</name>
      <address>
        <city>Munster</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Tubingen</name>
      <address>
        <city>Tubingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bajcsy-Zsilinszky Kórház és Rendelőintézet</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>L. V. Prasad Eye Institute - Hospital</name>
      <address>
        <city>Hyderabad</city>
        <state>Andhra Pradesh</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>L.V. Prasad Eye Institute</name>
      <address>
        <city>Patia</city>
        <state>Bhubaneshwar</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.H Nagri Municipal Eye Hospital</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seth G.S. Medical College &amp; KEM Hospital</name>
      <address>
        <city>Parel</city>
        <state>Mumbai</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PBMA'S H.V. Desai Eye Hospital</name>
      <address>
        <city>Hadapsar</city>
        <state>Pune</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King George's Medical University</name>
      <address>
        <city>Lucknow</city>
        <state>Uttar Pradesh</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah University Hospital Ein Kerem</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petah Tikva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Qiryat Ono</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Hospitals Trust</name>
      <address>
        <city>Belfast</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham and Midland Eye Centre</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bradford Royal Infirmary</name>
      <address>
        <city>Bradford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gloucestershire Royal Hospital</name>
      <address>
        <city>Gloucester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moorfields Eye Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Thomas Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Israel</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <results_first_submitted>March 25, 2019</results_first_submitted>
  <results_first_submitted_qc>March 4, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 23, 2020</results_first_posted>
  <last_update_submitted>March 5, 2021</last_update_submitted>
  <last_update_submitted_qc>March 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uveitis</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 20, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT01694186/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 5, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT01694186/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Sham Injection</title>
          <description>sham injection&#xD;
Sham injection</description>
        </group>
        <group group_id="P2">
          <title>FAI Insert</title>
          <description>FAI insert (0.18 mg fluocinolone acetonide)&#xD;
FAI insert</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="42">Two investigators each site Investigator 1 unmasked treating and investigator 2 masked follow up.</participants>
                <participants group_id="P2" count="87">Two investigators each site Investigator 1 unmasked treating and investigator 2 masked follow up.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36">Two investigators each site Investigator 1 unmasked treating and investigator 2 masked follow up.</participants>
                <participants group_id="P2" count="80">Two investigators each site Investigator 1 unmasked treating and investigator 2 masked follow up.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>A total of 129 (100%) subjects were included in the ITT and safety populations. 87 subjects in the FAI Insert 42 subjects in the Sham Injection</population>
      <group_list>
        <group group_id="B1">
          <title>Sham Injection</title>
          <description>Sham injection&#xD;
Sham injection</description>
        </group>
        <group group_id="B2">
          <title>FAI Insert</title>
          <description>FAI insert (0.18 mg fluocinolone acetonide)&#xD;
FAI insert</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="42"/>
            <count group_id="B2" value="87"/>
            <count group_id="B3" value="129"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.3" spread="13.71"/>
                    <measurement group_id="B2" value="48.3" spread="13.90"/>
                    <measurement group_id="B3" value="48.3" spread="13.79"/>
                  </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="29"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="50"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="56"/>
                  </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="16"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Israel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>India</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ITT and Safety populations</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>ITT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="87"/>
                    <measurement group_id="B3" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Safety</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="87"/>
                    <measurement group_id="B3" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit</title>
        <description>Safety: Ocular adverse events, including IOP elevation; medications/procedures required to control elevated IOP; development or worsening of cataract; cataract-related procedures; clinically significant ocular changes; procedure related adverse events Primary Efficacy Endpoint: Proportion of subjects who have a recurrence of uveitis in the study eye within 6 months after receiving study treatment.</description>
        <time_frame>36 months</time_frame>
        <population>Proportion of Subjects with Recurrence of Uveitis in the Study Eye at 36 Months (ITT Population)&#xD;
Overall Summary of Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit (Safety Population)</population>
        <group_list>
          <group group_id="O1">
            <title>Sham Injection</title>
            <description>sham injection&#xD;
Sham injection The sham applicator was an empty 1-mL syringe attached to a blunt 14-gauge needle; it did not contain an FAI insert. During study Day 1, the sham applicator was gently pressed against the study eye to provide the subject with the perception that an intravitreal injection was being performed. This procedure was performed to mask study subjects to their assigned treatment.</description>
          </group>
          <group group_id="O2">
            <title>FAI Insert</title>
            <description>FAI insert (0.18 mg fluocinolone acetonide) One treatment (FAI injection) was administered on Day 1 to each subject. The Fluocinolone Acetonide Intravitreal Insert (FAI insert) is an injectable intravitreal sustained-release FA delivery system preloaded into an injection device. Each insert contained a drug core of FA as the active ingredient within a cylindrical polyimide polymer tube 3.5-mm long with an external diameter of 0.37 mm.&#xD;
The dose delivered in the FAI insert was 0.18 mg fluocinolone acetonide delivered into the vitreous humor for 36 months. The FAI insert was administered to the study eye by injection through the pars plana using a preloaded applicator with a 25-gauge needle.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit</title>
          <description>Safety: Ocular adverse events, including IOP elevation; medications/procedures required to control elevated IOP; development or worsening of cataract; cataract-related procedures; clinically significant ocular changes; procedure related adverse events Primary Efficacy Endpoint: Proportion of subjects who have a recurrence of uveitis in the study eye within 6 months after receiving study treatment.</description>
          <population>Proportion of Subjects with Recurrence of Uveitis in the Study Eye at 36 Months (ITT Population)&#xD;
Overall Summary of Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit (Safety Population)</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="42"/>
                <count group_id="O2" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Protocol-Defined Recurrence of Uveitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ocular TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ocular Serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ocular Treatment- Related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ocular Treatment-Related Serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ocular TEAE leading to treatment discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ocular TEAE leading to study discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ocular AE leading to death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 years</time_frame>
      <desc>Treatment-Emergent Non-Ocular Adverse Events Through Month 36 Visit by System Organ Class and Preferred Term, Greater than 5% of Subjects in Either Treatment Group (Safety Population)</desc>
      <group_list>
        <group group_id="E1">
          <title>Sham Injection</title>
          <description>sham injection&#xD;
Sham injection</description>
        </group>
        <group group_id="E2">
          <title>FAI Insert</title>
          <description>FAI insert (0.18 mg fluocinolone acetonide)&#xD;
FAI insert</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (20.1)</default_vocab>
        <default_assessment>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="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Hydrocele</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blindness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Cystoid macular oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Hypotony of eye</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Macular oedema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Non-infectious endophthalmitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Ocular hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Uveitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Vitreous haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Vitritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Duodenitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Skull fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Post-procedural inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Intraocular pressure fluctuation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Intraocular pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Obesity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Foot deformity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Uterine cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Central nervous system lesion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Optic neuritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Premature baby</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Post-traumatic stress disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (20.1)</default_vocab>
        <default_assessment>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="40" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="84" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Anterior chamber flare</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="42"/>
                <counts group_id="E2" events="33" subjects_affected="33" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Cataract subcapsular</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="42"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Cystoid macular oedema</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="42"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="42"/>
                <counts group_id="E2" events="15" subjects_affected="15" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="42"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Eyelid ptosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Foreign body sensation in eyes</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Iridocyclitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="42"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Macular fibrosis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="42"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Macular oedema</sub_title>
                <counts group_id="E1" events="16" subjects_affected="16" subjects_at_risk="42"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Ocular discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="42"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Photopsia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Posterior capsule opacification</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Uveitis</sub_title>
                <counts group_id="E1" events="26" subjects_affected="26" subjects_at_risk="42"/>
                <counts group_id="E2" events="18" subjects_affected="18" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Visual acuity reduced</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="42"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Vitreous floaters</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="42"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Vitreous opacities</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="42"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Intraocular pressure increased</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="42"/>
                <counts group_id="E2" events="28" subjects_affected="28" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="87"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Affairs</name_or_title>
      <organization>Eyepoint Pharmacueticals</organization>
      <phone>6179726204</phone>
      <email>fleonin@eyepointpharma.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/NCT01694186
org study id: PSV-FAI-001
nct id: NCT01694186
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A study to evaluate the safety and efficacy of an FAI insert for the management of subjects
      with non-infectious uveitis affecting the posterior segment of the eye.
This is a phase 3, multi-national, multi-center, randomized, masked, controlled study to
      evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal (FAI)
      insert for the management of subjects with non-infectious uveitis affecting the posterior
      segment of the eye. Patients will be randomized to receive either a sham injection or the FAI
      insert and will be observed for three years following treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit
time frame: 36 months
description: Safety: Ocular adverse events, including IOP elevation; medications/procedures required to control elevated IOP; development or worsening of cataract; cataract-related procedures; clinically significant ocular changes; procedure related adverse events Primary Efficacy Endpoint: Proportion of subjects who have a recurrence of uveitis in the study eye within 6 months after receiving study treatment.
arm group label: sham injection
arm group type: Sham Comparator
description: sham injection
arm group label: FAI insert
arm group type: Experimental
description: FAI insert (0.18 mg fluocinolone acetonide)
intervention type: Drug
intervention name: FAI insert
arm group label: FAI insert
other name: Active Drug
intervention type: Drug
intervention name: Sham injection
arm group label: sham injection
other name: Sham Comparator
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Glenn Jaffe, MD
role: Principal Investigator
affiliation: Duke University Eye Center
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country: Germany
country: Hungary
country: India
country: Israel
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Uveitis
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