<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/NCT03274024</url>
  </required_header>
  <id_info>
    <org_study_id>R1293/99/2015</org_study_id>
    <nct_id>NCT03274024</nct_id>
  </id_info>
  <brief_title>The Asia Primary Tube Versus Trab (TVT) Study</brief_title>
  <acronym>TVT</acronym>
  <official_title>The Asia Primary Tube Versus Trab (TVT) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Singapore Eye Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Medical Research Council (NMRC), Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Singapore Eye Research Institute</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>
      Comparison of Ahmed Glaucoma Implant (AGI) against trabeculectomy with mitomycin C in&#xD;
      patients with uncontrolled open angle glaucoma&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of the Asia Primary Tube versus Trab (TVT) study is to compare the efficacy and&#xD;
      safety of placement of an Ahmed Glaucoma Implant (AGI) (New World Medical Inc., Rancho&#xD;
      Cucamonga, CA, USA) against trabeculectomy with mitomycin C in patients with uncontrolled&#xD;
      glaucoma, who may or may not have had previous clear corneal cataract surgery with&#xD;
      intraocular lens implantation, over 5 years. Outcome discrimination between the two treatment&#xD;
      groups will be made using following parameters:&#xD;
&#xD;
        1. Intraocular pressure&#xD;
&#xD;
        2. Need for supplemental medical therapy&#xD;
&#xD;
        3. Incidence of short and long term surgical complications and need for re-operation.&#xD;
&#xD;
        4. Visual function (Visual acuity and Visual field)&#xD;
&#xD;
      Hypothesis: Glaucoma drainage implants have better surgical outcomes in terms of IOP lowering&#xD;
      efficacy compared to trabeculectomy with mitomycin-C over 5 years in Asian patients with&#xD;
      medically uncontrolled glaucoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 28, 2016</start_date>
  <completion_date type="Anticipated">October 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2020</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Failure</measure>
    <time_frame>6 months</time_frame>
    <description>Failure defined by ANY of the following criteria:&#xD;
IOP ≥ 18 mm Hg on two consecutive follow-up visits after 6 months&#xD;
IOP not reduced to 20% below baseline on two consecutive visits after 6 months&#xD;
IOP ≤ 5 mm Hg with visually significant hypotony maculopathy on two consecutive visits after 3 months&#xD;
Additional glaucoma surgery, excluding laser suture lysis, removal of releasable trabeculectomy or conjunctival sutures, needling of the bleb or tube plate with or without 5FU, subconjunctival 5FU injections and anterior chamber reformation.&#xD;
Loss of light perception vision</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>IOP</measure>
    <time_frame>60 months</time_frame>
    <description>Intraocular pressure (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Corrected Visual Acuity (BCVA)</measure>
    <time_frame>60 months</time_frame>
    <description>ETDRS visual acuity chart (logMAR or equivalent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Supplemental medication</measure>
    <time_frame>60 months</time_frame>
    <description>Number of supplemental glaucoma medications used at Month 60</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>60 months</time_frame>
    <description>Number of Adverse Events during the trial</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Glaucoma</condition>
  <arm_group>
    <arm_group_label>Tube implant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ahmed Glaucoma Implant (AGI) surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trabeculectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Trabeculectomy with mitomycin C surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ahmed Glaucoma Implant</intervention_name>
    <description>Conjunctival Flap Scleral Exposure Insertion of Episcleral Plate Priming of the tube prior to AC entrance Insertion of Tube into the Anterior Chamber Suturing tube Coverage of tube</description>
    <arm_group_label>Tube implant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Trabeculectomy with Mitomycin C</intervention_name>
    <description>Conjunctival Flap Mitomycin C Application Scleral Flap Paracentesis Excision of Limbal Tissue Peripheral Iridectomy Scleral Flap Closure Conjunctival Flap Closure</description>
    <arm_group_label>Trabeculectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Open angle glaucoma including primary open angle glaucoma, pseudoexfoliative or&#xD;
             pigmentary glaucoma.&#xD;
&#xD;
          2. IOP &gt; 18 mm Hg on 2 or more medications on at least 2 visits&#xD;
&#xD;
          3. Informed consent given and consent form signed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unwilling or unable to give consent, unwilling to accept randomisation, or unable to&#xD;
             return for scheduled protocol visits.&#xD;
&#xD;
          2. Pregnant or nursing women&#xD;
&#xD;
          3. No light perception vision&#xD;
&#xD;
          4. Previous incisional intraocular surgery, other than uncomplicated clear corneal&#xD;
             cataract surgery&#xD;
&#xD;
          5. Previous ocular laser in study eye (keratorefractive surgery and cyclodestructive&#xD;
             procedure), except for laser trabeculoplasty procedures (Argon Laser and Selective&#xD;
             Laser Trabeculoplasty)&#xD;
&#xD;
          6. Iris neovascularisation or proliferative retinopathy&#xD;
&#xD;
          7. Primary angle closure or primary angle closure glaucoma&#xD;
&#xD;
          8. Iridocorneal endothelial syndrome or anterior segment dysgenesis&#xD;
&#xD;
          9. Epithelial or fibrous downgrowth&#xD;
&#xD;
         10. Aphakia&#xD;
&#xD;
         11. Chronic or recurrent uveitis&#xD;
&#xD;
         12. Severe posterior blepharitis&#xD;
&#xD;
         13. Unwilling to discontinue contact lens use after surgery&#xD;
&#xD;
         14. Glaucoma secondary to penetrating keratoplasty, trauma, steroids, retinal&#xD;
             disease/surgery or neovascular disease&#xD;
&#xD;
         15. Conjunctival scarring from prior ocular surgery, trauma or cicatrizing disease&#xD;
             precluding a superior trabeculectomy&#xD;
&#xD;
         16. Need for glaucoma surgery combined with other ocular procedures (i.e. cataract&#xD;
             surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for urgent&#xD;
             additional ocular surgery&#xD;
&#xD;
         17. Advanced glaucoma with MD &lt;-20dB&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ching Lin Ho</last_name>
    <role>Principal Investigator</role>
    <affiliation>Singapore National Eye Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Natalia Porporato, Fellow</last_name>
    <phone>+6591378217</phone>
    <email>natalia.porporato@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ya Ying Ooi</last_name>
    <phone>+658186 7051</phone>
    <email>ooi.ya.ying@seri.com.sg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Singapore Eye Research Institute</name>
      <address>
        <city>Singapore</city>
        <zip>168751</zip>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Serena Ting</last_name>
      <phone>(+65) 8113 5026</phone>
      <email>serena.ting.m.l@seri.com.sg</email>
    </contact>
    <investigator>
      <last_name>Ching Lin Ho, A/Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 29, 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>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Singapore Eye Research Institute</investigator_affiliation>
    <investigator_full_name>Dr Ho Ching Lin</investigator_full_name>
    <investigator_title>Research Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitomycins</mesh_term>
    <mesh_term>Mitomycin</mesh_term>
  </intervention_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/NCT03274024
org study id: R1293/99/2015
nct id: NCT03274024
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Comparison of Ahmed Glaucoma Implant (AGI) against trabeculectomy with mitomycin C in
      patients with uncontrolled open angle glaucoma
The objective of the Asia Primary Tube versus Trab (TVT) study is to compare the efficacy and
      safety of placement of an Ahmed Glaucoma Implant (AGI) (New World Medical Inc., Rancho
      Cucamonga, CA, USA) against trabeculectomy with mitomycin C in patients with uncontrolled
      glaucoma, who may or may not have had previous clear corneal cataract surgery with
      intraocular lens implantation, over 5 years. Outcome discrimination between the two treatment
      groups will be made using following parameters:

        1. Intraocular pressure

        2. Need for supplemental medical therapy

        3. Incidence of short and long term surgical complications and need for re-operation.

        4. Visual function (Visual acuity and Visual field)

      Hypothesis: Glaucoma drainage implants have better surgical outcomes in terms of IOP lowering
      efficacy compared to trabeculectomy with mitomycin-C over 5 years in Asian patients with
      medically uncontrolled glaucoma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Failure
time frame: 6 months
description: Failure defined by ANY of the following criteria:
IOP ≥ 18 mm Hg on two consecutive follow-up visits after 6 months
IOP not reduced to 20% below baseline on two consecutive visits after 6 months
IOP ≤ 5 mm Hg with visually significant hypotony maculopathy on two consecutive visits after 3 months
Additional glaucoma surgery, excluding laser suture lysis, removal of releasable trabeculectomy or conjunctival sutures, needling of the bleb or tube plate with or without 5FU, subconjunctival 5FU injections and anterior chamber reformation.
Loss of light perception vision
measure: IOP
time frame: 60 months
description: Intraocular pressure (mmHg)
measure: Best Corrected Visual Acuity (BCVA)
time frame: 60 months
description: ETDRS visual acuity chart (logMAR or equivalent)
measure: Supplemental medication
time frame: 60 months
description: Number of supplemental glaucoma medications used at Month 60
measure: Adverse Events
time frame: 60 months
description: Number of Adverse Events during the trial
arm group label: Tube implant
arm group type: Experimental
description: Ahmed Glaucoma Implant (AGI) surgery
arm group label: Trabeculectomy
arm group type: Active Comparator
description: Trabeculectomy with mitomycin C surgery
intervention type: Device
intervention name: Ahmed Glaucoma Implant
description: Conjunctival Flap Scleral Exposure Insertion of Episcleral Plate Priming of the tube prior to AC entrance Insertion of Tube into the Anterior Chamber Suturing tube Coverage of tube
arm group label: Tube implant
intervention type: Procedure
intervention name: Trabeculectomy with Mitomycin C
description: Conjunctival Flap Mitomycin C Application Scleral Flap Paracentesis Excision of Limbal Tissue Peripheral Iridectomy Scleral Flap Closure Conjunctival Flap Closure
arm group label: Trabeculectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Ching Lin Ho
role: Principal Investigator
affiliation: Singapore National Eye Centre
last name: Natalia Porporato, Fellow
phone: +6591378217
email: natalia.porporato@gmail.com
last name: Ya Ying Ooi
phone: +658186 7051
email: ooi.ya.ying@seri.com.sg
facility: 
status: Recruiting
contact: 
investigator: 
country: Singapore
responsible party type: Principal Investigator
investigator affiliation: Singapore Eye Research Institute
investigator full name: Dr Ho Ching Lin
investigator title: Research Director
mesh term: Glaucoma
mesh term: Mitomycins
mesh term: Mitomycin