<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/NCT02990143</url>
  </required_header>
  <id_info>
    <org_study_id>13.33</org_study_id>
    <nct_id>NCT02990143</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Ologen® Collagen Matrix in Preventing Intraocular Pressure (IOP) Spikes After Ahmed Glaucoma Valve Surgery (AGV-FP7)</brief_title>
  <official_title>The Effectiveness of Ologen® Collagen Matrix in Preventing Intraocular Pressure (IOP) Spikes After Ahmed Glaucoma Valve Surgery (AGV-FP7)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The New York Eye &amp; Ear Infirmary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The New York Eye &amp; Ear Infirmary</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate whether placing Ologen over the posterior plate&#xD;
      of the Ahmed glaucoma drainage device during initial implantation will allow the formation of&#xD;
      a thinner capsule, and decrease the incidence and/or the extent of IOP elevation during the&#xD;
      postoperative period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Uncontrolled glaucoma may require surgical intervention. Glaucoma drainage implants such as&#xD;
      AGV-FP7 are in wide use upon glaucoma and comprehensive surgeons. The success of aqueous&#xD;
      shunt surgery depends on the formation and maintenance of a thin permeable capsule around the&#xD;
      posterior plate of the aqueous shunt. Encapsulated bleb formation, where the capsule is thick&#xD;
      and elevated, is a common cause of drainage failure in the early post-operative period. This&#xD;
      finding is usually accompanied by elevated intraocular pressure (IOP), which requires&#xD;
      additional intervention, often surgical and therefore reduces the success rate of the initial&#xD;
      surgery.&#xD;
&#xD;
      Recently, a biodegradable porous collagen-glycosaminoglycan copolymer matrix implant&#xD;
      (Ologen), has become available for glaucoma surgery. This device is constructed so as to&#xD;
      minimize random growth of fibroblasts and instead to allow them to grow through the pores in&#xD;
      the matrix. Ologen® CM,a biodegradable scaffold matrix, induces a regenerative non-scarring&#xD;
      wound healing process without using anti-fibrotic agents.&#xD;
&#xD;
      This study is to investigate whether placing Ologen over the posterior plate of the Ahmed&#xD;
      glaucoma drainage device during initial implantation will allow the formation of a thinner&#xD;
      capsule, and decrease the incidence and/or the extent of IOP elevation during the&#xD;
      postoperative period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Investigator left the Institution&#xD;
  </why_stopped>
  <start_date type="Actual">January 15, 2014</start_date>
  <completion_date type="Actual">December 15, 2017</completion_date>
  <primary_completion_date type="Actual">December 15, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Effectiveness of ologen® Collagen Matrix in preventing intraocular pressure (IOP) spikes after Ahmed Glaucoma Valve Surgery (AGV-FP7)</measure>
    <time_frame>1 year</time_frame>
    <description>Ologen over the posterior plate of the Ahmed glaucoma drainage device during initial implantation will allow the formation of a thinner capsule, and decrease the incidence and/or the extent of IOP elevation during the postoperative period.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>Glaucoma Drainage implant no Ologen</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The first group will use the routine technique for glaucoma drainage implant without placement of Ologen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glaucoma Drainage implant with Ologen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the second group will undergo the same procedure but will have the Ologen placed and secured over the plate of the AGV-FP7, under the conjunctiva, during the surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ologen</intervention_name>
    <description>Ologen® CM,a biodegradable scaffold matrix, induces a regenerative non-scarring wound healing process without using anti-fibrotic agents.</description>
    <arm_group_label>Glaucoma Drainage implant with Ologen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years.&#xD;
&#xD;
          -  Uncontrolled treated glaucoma requiring AGV-FP7 surgery.&#xD;
&#xD;
          -  Subject must be able and willing to cooperate with investigation plan.&#xD;
&#xD;
          -  Subject must be able and willing to complete postoperative follow-up requirements&#xD;
&#xD;
          -  Subject must be willing to sign informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergic reaction to porcine collagen&#xD;
&#xD;
          -  History of uveitis&#xD;
&#xD;
          -  Corneal opacity or irregularity, preventing visualization of patency of tip of tube or&#xD;
             accurate applanation&#xD;
&#xD;
          -  History of scleral buckle&#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>Noga Harizman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NY Eye Ear</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York Eye and Ear Infirmary</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>March 15, 2021</last_update_submitted>
  <last_update_submitted_qc>March 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 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>Glaucoma</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/NCT02990143
org study id: 13.33
nct id: NCT02990143
lead sponsor: 
has dmc: No
The purpose of this study is to investigate whether placing Ologen over the posterior plate
      of the Ahmed glaucoma drainage device during initial implantation will allow the formation of
      a thinner capsule, and decrease the incidence and/or the extent of IOP elevation during the
      postoperative period.
Uncontrolled glaucoma may require surgical intervention. Glaucoma drainage implants such as
      AGV-FP7 are in wide use upon glaucoma and comprehensive surgeons. The success of aqueous
      shunt surgery depends on the formation and maintenance of a thin permeable capsule around the
      posterior plate of the aqueous shunt. Encapsulated bleb formation, where the capsule is thick
      and elevated, is a common cause of drainage failure in the early post-operative period. This
      finding is usually accompanied by elevated intraocular pressure (IOP), which requires
      additional intervention, often surgical and therefore reduces the success rate of the initial
      surgery.

      Recently, a biodegradable porous collagen-glycosaminoglycan copolymer matrix implant
      (Ologen), has become available for glaucoma surgery. This device is constructed so as to
      minimize random growth of fibroblasts and instead to allow them to grow through the pores in
      the matrix. Ologen® CM,a biodegradable scaffold matrix, induces a regenerative non-scarring
      wound healing process without using anti-fibrotic agents.

      This study is to investigate whether placing Ologen over the posterior plate of the Ahmed
      glaucoma drainage device during initial implantation will allow the formation of a thinner
      capsule, and decrease the incidence and/or the extent of IOP elevation during the
      postoperative period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: The Effectiveness of ologen® Collagen Matrix in preventing intraocular pressure (IOP) spikes after Ahmed Glaucoma Valve Surgery (AGV-FP7)
time frame: 1 year
description: Ologen over the posterior plate of the Ahmed glaucoma drainage device during initial implantation will allow the formation of a thinner capsule, and decrease the incidence and/or the extent of IOP elevation during the postoperative period.
arm group label: Glaucoma Drainage implant no Ologen
arm group type: No Intervention
description: The first group will use the routine technique for glaucoma drainage implant without placement of Ologen.
arm group label: Glaucoma Drainage implant with Ologen
arm group type: Active Comparator
description: the second group will undergo the same procedure but will have the Ologen placed and secured over the plate of the AGV-FP7, under the conjunctiva, during the surgery.
intervention type: Procedure
intervention name: Ologen
description: Ologen® CM,a biodegradable scaffold matrix, induces a regenerative non-scarring wound healing process without using anti-fibrotic agents.
arm group label: Glaucoma Drainage implant with Ologen
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Noga Harizman, MD
role: Principal Investigator
affiliation: NY Eye Ear
facility: 
country: United States
responsible party type: Sponsor
mesh term: Glaucoma