<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/NCT02193945</url>
  </required_header>
  <id_info>
    <org_study_id>TG-MV-022</org_study_id>
    <nct_id>NCT02193945</nct_id>
  </id_info>
  <brief_title>A Retrospective Chart Review of Patients Treated With Ocriplasmin for Symptomatic VMA</brief_title>
  <acronym>OZONE</acronym>
  <official_title>OZONE: Ocriplasmin Ellipsoid Zone Retrospective Data Collection Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ThromboGenics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ThromboGenics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to retrospectively review and further characterize anatomic and&#xD;
      symptomatic changes over six months immediately following treatment of symptomatic&#xD;
      vitreomacular adhesion (VMA) with JETREA® (ocriplasmin), including incidence, time to onset&#xD;
      and resolution of anatomy and symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study (TG-MV-022) is a retrospective study utilizing Spectral-domain optical coherence&#xD;
      tomography (SD-OCT) in patients treated previously with JETREA® for VMA. The objectives of&#xD;
      this study are to retrospectively review and further characterize anatomic and symptomatic&#xD;
      changes over six months immediately following treatment of VMA with JETREA® (ocriplasmin),&#xD;
      including incidence, time to onset and resolution of anatomy and symptoms. The retrospective&#xD;
      study will collect Heidelberg Spectralis® SD-OCT images which will be masked and uploaded to&#xD;
      a Central Reading Center (CRC) for review and analysis. The CRC will evaluate anatomic&#xD;
      endpoints of interest from both baseline optical coherence tomography (OCT) images and all&#xD;
      follow-up OCT scans over the 6 month follow up period. Endpoints of interest include&#xD;
      ellipsoid zone disruption, development of subretinal fluid, resolution of VMA and macular&#xD;
      hole changes. Further, trained clinical personnel at the participating centers will&#xD;
      transcribe data from the patients' records, to be entered into the study database.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients with ellipsoid zone disruption by Day 21 post-JETREA® injection, determined by a Central Reading Center (CRC), that was not present at baseline.</measure>
    <time_frame>Day 21</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with ellipsoid zone disruption, not present at baseline</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with ellipsoid zone disruption with resolution</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to onset of ellipsoid zone disruption</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to resolution of ellipsoid zone disruption</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients that developed subretinal fluid, not present at baseline</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients that developed subretinal fluid with resolution</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to onset of subretinal fluid</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to resolution of subretinal fluid</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with nonsurgical resolution of VMA by Day 28</measure>
    <time_frame>Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to resolution of VMA</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients that developed a macular hole by Day 28, not present at baseline</measure>
    <time_frame>Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with nonsurgical closure of macular hole, if present at baseline by Day 28</measure>
    <time_frame>Day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with worsening (enlargement) of macular hole, if present at baseline</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>No change of macular hole, if present at baseline</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients that underwent vitrectomy</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Acuity (VA) changes from baseline</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other findings as examined and documented in the patient's medical records</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Impaired pupillary reflex&#xD;
Dyschromatopsia&#xD;
ERG changes&#xD;
Vascular changes&#xD;
Visual field constriction&#xD;
Lens changes post- JETREA® injection including, subluxation, dislocation, phacodenesis&#xD;
Other changes in quality of vision including, darkness of vision, dark adaptation changes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Monitoring of Adverse Drug Reactions (ADRs)</measure>
    <time_frame>Up to 6 motnths</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">134</enrollment>
  <condition>Symptomatic Vitreomacular Adhesion (VMA)</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have been treated with JETREA® for Symptomatic vitreomacular adhesion (VMA)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Must be at least 18 years of age or older.&#xD;
&#xD;
          2. Have been treated with JETREA® for vitreomacular adhesion (VMA) between April 1, 2013&#xD;
             and December 31, 2013 with at least six months of follow up visits post injection.&#xD;
             Note: If a patient's second eye was treated, only the first eye treated is eligible&#xD;
             for study participation.&#xD;
&#xD;
          3. Have been imaged with Heidelberg Spectralis SD-OCT at least one time within 30 days&#xD;
             prior to JETREA® injection.&#xD;
&#xD;
          4. Have been imaged with Heidelberg Spectralis SD-OCT at least two times post JETREA®&#xD;
             injection with at least one scan between Days 1-21 and the second scan within six&#xD;
             months,, including a corresponding visual acuity (VA).&#xD;
&#xD;
          5. Be willing and able to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients treated with JETREA® for medical conditions outside of the product label.&#xD;
&#xD;
          2. Patients with other retinal conditions that affect the vitreo-retinal interface, or&#xD;
             can lead to retinal atrophy, including but not limited to:&#xD;
&#xD;
               -  Neovascular age-related macular degeneration;&#xD;
&#xD;
               -  Fibrovascular scar;&#xD;
&#xD;
               -  Diabetic macular edema; and&#xD;
&#xD;
               -  Proliferative diabetic retinopathy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Retinal Diagnostic Center</name>
      <address>
        <city>Campbell</city>
        <state>California</state>
        <zip>95008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scripps Clinic</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</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</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Vitreous Associates of Florida</name>
      <address>
        <city>St. Petersburg</city>
        <state>Florida</state>
        <zip>33711</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>Rush university medical center-Dept ophthalmology</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</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>Sabates Eye Centers</name>
      <address>
        <city>Leawood</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carl W. Baker</name>
      <address>
        <city>Paducah</city>
        <state>Kentucky</state>
        <zip>42001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ophthalmic Consultants of Boston</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harvard Vanguard Medical Associates</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sierra Eye Associates</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eyesight Ophthalmic Services</name>
      <address>
        <city>Portsmouth</city>
        <state>New Hampshire</state>
        <zip>03801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MaculaCare</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</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>Wills Eye Institute</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</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeastern Retina Associates, P.C.</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</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, PA</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Specialists</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Associates of Utah, P.C.</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University Eye Institute</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>July 8, 2015</last_update_submitted>
  <last_update_submitted_qc>July 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 9, 2015</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>Tissue Adhesions</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02193945
org study id: TG-MV-022
nct id: NCT02193945
lead sponsor: 
has dmc: No
The purpose of this study is to retrospectively review and further characterize anatomic and
      symptomatic changes over six months immediately following treatment of symptomatic
      vitreomacular adhesion (VMA) with JETREA® (ocriplasmin), including incidence, time to onset
      and resolution of anatomy and symptoms.
This study (TG-MV-022) is a retrospective study utilizing Spectral-domain optical coherence
      tomography (SD-OCT) in patients treated previously with JETREA® for VMA. The objectives of
      this study are to retrospectively review and further characterize anatomic and symptomatic
      changes over six months immediately following treatment of VMA with JETREA® (ocriplasmin),
      including incidence, time to onset and resolution of anatomy and symptoms. The retrospective
      study will collect Heidelberg Spectralis® SD-OCT images which will be masked and uploaded to
      a Central Reading Center (CRC) for review and analysis. The CRC will evaluate anatomic
      endpoints of interest from both baseline optical coherence tomography (OCT) images and all
      follow-up OCT scans over the 6 month follow up period. Endpoints of interest include
      ellipsoid zone disruption, development of subretinal fluid, resolution of VMA and macular
      hole changes. Further, trained clinical personnel at the participating centers will
      transcribe data from the patients' records, to be entered into the study database.
observational model: Case-Only
time perspective: Retrospective
measure: Proportion of patients with ellipsoid zone disruption by Day 21 post-JETREA® injection, determined by a Central Reading Center (CRC), that was not present at baseline.
time frame: Day 21
measure: Proportion of patients with ellipsoid zone disruption, not present at baseline
time frame: Up to 6 months
measure: Proportion of patients with ellipsoid zone disruption with resolution
time frame: Up to 6 months
measure: Time to onset of ellipsoid zone disruption
time frame: Up to 6 months
measure: Time to resolution of ellipsoid zone disruption
time frame: Up to 6 months
measure: Proportion of patients that developed subretinal fluid, not present at baseline
time frame: Up to 6 months
measure: Proportion of patients that developed subretinal fluid with resolution
time frame: Up to 6 months
measure: Time to onset of subretinal fluid
time frame: Up to 6 months
measure: Time to resolution of subretinal fluid
time frame: Up to 6 months
measure: Proportion of patients with nonsurgical resolution of VMA by Day 28
time frame: Day 28
measure: Time to resolution of VMA
time frame: Up to 6 months
measure: Proportion of patients that developed a macular hole by Day 28, not present at baseline
time frame: Day 28
measure: Proportion of patients with nonsurgical closure of macular hole, if present at baseline by Day 28
time frame: Day 28
measure: Proportion of patients with worsening (enlargement) of macular hole, if present at baseline
time frame: Up to 6 months
measure: No change of macular hole, if present at baseline
time frame: Up to 6 months
measure: Proportion of patients that underwent vitrectomy
time frame: Up to 6 months
measure: Visual Acuity (VA) changes from baseline
time frame: Up to 6 months
measure: Other findings as examined and documented in the patient's medical records
time frame: Up to 6 months
description: Impaired pupillary reflex
Dyschromatopsia
ERG changes
Vascular changes
Visual field constriction
Lens changes post- JETREA® injection including, subluxation, dislocation, phacodenesis
Other changes in quality of vision including, darkness of vision, dark adaptation changes
measure: Monitoring of Adverse Drug Reactions (ADRs)
time frame: Up to 6 motnths
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Tissue Adhesions