<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/NCT03274323</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00146334</org_study_id>
    <nct_id>NCT03274323</nct_id>
  </id_info>
  <brief_title>Trabeculectomy Versus 2-iStent and Prostaglandin Study</brief_title>
  <acronym>TIPS</acronym>
  <official_title>Trabeculectomy Versus 2-iStent and Prostaglandin Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators hypothesize that the synergistic action of iStent in increasing aqueous outflow&#xD;
      through the trabecular meshwork and use of prostaglandin analog such as travoprost or&#xD;
      latanoprost to increase uveoscleral outflow will achieve good Intra-ocular Pressure (IOP)&#xD;
      control with minimal complications in Primary Open Angle Glaucoma (POAG) patients with&#xD;
      suboptimal IOP on 2 or more medications compared to mitomycin C (MMC) augmented&#xD;
      trabeculectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a prospective randomized controlled study.&#xD;
&#xD;
      20 phakic or pseudophakic open angle glaucoma patients with an IOP in the range of 18-30 mmHg&#xD;
      on 2 or more topical glaucoma medications will be randomly selected to undergo either (1)&#xD;
      mitomycin-augmented trabeculectomy or (2) placement of 2 iStent devices and initiation of a&#xD;
      daily prostaglandin analog. This study is looking at the combined effects of the 2 iStents&#xD;
      and a prostaglandin analog as a method to achieve low IOP. At 3 months (+/- 2 weeks)&#xD;
      postoperatively, the iStent patients will be left only on the prostaglandin analog with a&#xD;
      washout performed for any other hypotensive medication used. Patients who had a&#xD;
      trabeculectomy will be have a terminal washout of all IOP-lowering medications at 3 months&#xD;
      (+/- 2 weeks) post-surgery. The IOP will then be measured for both groups at 4 months (+/- 3&#xD;
      weeks) postoperatively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Difficulty obtaining IDE by the FDA. Currently not worthwhile to pursue further.&#xD;
  </why_stopped>
  <start_date type="Actual">January 12, 2018</start_date>
  <completion_date type="Actual">January 12, 2018</completion_date>
  <primary_completion_date type="Actual">January 12, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IOP &lt;= 18 mmHg</measure>
    <time_frame>Post surgery month 4</time_frame>
    <description>IOP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IOP &lt;= 15 mmHg</measure>
    <time_frame>Post surgery month 4</time_frame>
    <description>IOP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IOP &gt;= 20% reduction from untreated baseline</measure>
    <time_frame>Post surgery month 4</time_frame>
    <description>IOP</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Glaucoma, Open-Angle</condition>
  <arm_group>
    <arm_group_label>2 iStent with travoprost or latanoprost</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 iStents will be injected into the trabecular meshwork and patients will be administered topical latanoprost or travoprost following surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>trabeculectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard trabeculectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iStent and travoprost or latanoprost</intervention_name>
    <description>2 iStents will be inserted and patients will be started on travoprost or latanoprost following the procedure</description>
    <arm_group_label>2 iStent with travoprost or latanoprost</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Trabeculectomy</intervention_name>
    <description>Standard trabeculectomy</description>
    <arm_group_label>trabeculectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have mental capacity to give consent&#xD;
&#xD;
          -  Age &gt;= 21 years&#xD;
&#xD;
          -  Pseudophakic or phakic without visually significant cataract&#xD;
&#xD;
          -  Open angle glaucoma&#xD;
&#xD;
          -  IOP in the range of 18-30 mmHg with 2 or more topical medications&#xD;
&#xD;
          -  Cup-disc ratio =&lt; 0.9&#xD;
&#xD;
          -  Best corrected visual acuity of 20/100 or better&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to give consent&#xD;
&#xD;
          -  Inability to tolerate or presence of allergy to prostaglandin analogs&#xD;
&#xD;
          -  Patient preference for non-surgical treatment or preference for either of the&#xD;
             recommended surgical modalities in the study&#xD;
&#xD;
          -  Age &lt; 21 years&#xD;
&#xD;
          -  Visually significant cataract that would benefit from cataract surgery, as determined&#xD;
             by the treating surgeon in consultation with the patient&#xD;
&#xD;
          -  Secondary glaucoma or angle closure glaucoma&#xD;
&#xD;
          -  Aphakia&#xD;
&#xD;
          -  Prior glaucoma incisional surgery (trabeculectomy, tube surgery, other Microinvasive&#xD;
             Glaucoma Surgery (MIGS) surgeries, deep sclerectomy)&#xD;
&#xD;
          -  Prior laser trabeculoplasty &lt; 90 days prior to screening or absolute failure of prior&#xD;
             laser trabeculoplasty.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>January 17, 2018</last_update_submitted>
  <last_update_submitted_qc>January 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2018</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, Open-Angle</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Travoprost</mesh_term>
    <mesh_term>Latanoprost</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03274323
org study id: IRB00146334
nct id: NCT03274323
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Investigators hypothesize that the synergistic action of iStent in increasing aqueous outflow
      through the trabecular meshwork and use of prostaglandin analog such as travoprost or
      latanoprost to increase uveoscleral outflow will achieve good Intra-ocular Pressure (IOP)
      control with minimal complications in Primary Open Angle Glaucoma (POAG) patients with
      suboptimal IOP on 2 or more medications compared to mitomycin C (MMC) augmented
      trabeculectomy.
This will be a prospective randomized controlled study.

      20 phakic or pseudophakic open angle glaucoma patients with an IOP in the range of 18-30 mmHg
      on 2 or more topical glaucoma medications will be randomly selected to undergo either (1)
      mitomycin-augmented trabeculectomy or (2) placement of 2 iStent devices and initiation of a
      daily prostaglandin analog. This study is looking at the combined effects of the 2 iStents
      and a prostaglandin analog as a method to achieve low IOP. At 3 months (+/- 2 weeks)
      postoperatively, the iStent patients will be left only on the prostaglandin analog with a
      washout performed for any other hypotensive medication used. Patients who had a
      trabeculectomy will be have a terminal washout of all IOP-lowering medications at 3 months
      (+/- 2 weeks) post-surgery. The IOP will then be measured for both groups at 4 months (+/- 3
      weeks) postoperatively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: IOP <= 18 mmHg
time frame: Post surgery month 4
description: IOP
measure: IOP <= 15 mmHg
time frame: Post surgery month 4
description: IOP
measure: IOP >= 20% reduction from untreated baseline
time frame: Post surgery month 4
description: IOP
arm group label: 2 iStent with travoprost or latanoprost
arm group type: Experimental
description: 2 iStents will be injected into the trabecular meshwork and patients will be administered topical latanoprost or travoprost following surgery
arm group label: trabeculectomy
arm group type: Active Comparator
description: Standard trabeculectomy
intervention type: Device
intervention name: iStent and travoprost or latanoprost
description: 2 iStents will be inserted and patients will be started on travoprost or latanoprost following the procedure
arm group label: 2 iStent with travoprost or latanoprost
intervention type: Procedure
intervention name: Trabeculectomy
description: Standard trabeculectomy
arm group label: trabeculectomy
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Glaucoma, Open-Angle
mesh term: Travoprost
mesh term: Latanoprost
sharing ipd: No