<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/NCT03037736</url>
  </required_header>
  <id_info>
    <org_study_id>OPPS</org_study_id>
    <nct_id>NCT03037736</nct_id>
  </id_info>
  <brief_title>Outpatient Performed Pterygium Surgery Study</brief_title>
  <acronym>OPPS</acronym>
  <official_title>Outpatient Performed Pterygium Surgery Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized controlled trial of postoperative bevacizumab or 5-fluorouracil&#xD;
      subconjunctival injections vs placebo for the recurrence of pterygia after excision using&#xD;
      conjunctival autograft.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be randomized at enrollment to one of three arms: 5-Fluorouracil (5-FU)&#xD;
      5mg/0.1mL, bevacizumab 2.5mg/0.1mL, or placebo. The placebo will be sterile,&#xD;
      preservative-free injectable 0.9% normal saline. All patients will undergo pterygium excision&#xD;
      surgery in the minor procedure room using a standardized surgical technique with conjunctival&#xD;
      autograft. All patients will have a standardized postoperative drop protocol of&#xD;
      neomycin/polymyxin/dexamethasone ointment four times daily for 2 weeks and fluorometholone&#xD;
      drops 4 times daily for 2 weeks, three times daily for 2 weeks, twice daily for 2 weeks, once&#xD;
      daily for 2 weeks then stopping.&#xD;
&#xD;
      At the 1-month and 2-month postoperative visits, patients will receive a subconjunctival&#xD;
      injection based on their randomization assignment (5-FU, bevacizumab or placebo) in the area&#xD;
      of the excised pterygium at least 1 mm posterior to the limbus. The total injected volume&#xD;
      will be 0.1mL for all adjuvants.&#xD;
&#xD;
      The primary outcome will pterygium recurrence at 3 months, defined as evidence of at least 1&#xD;
      mm of fibrovascular growth onto the cornea. After the 3 month visit, patients who are&#xD;
      determined to have a recurrence will be unmasked, and can received monthly 5-FU or&#xD;
      bevacizumab injections at the discretion of the treating physician. Each of these visits will&#xD;
      be treated as a study visit, and will be documented.&#xD;
&#xD;
      All patients will have study visits at the 6 and 12 month mark. If at any point any patient&#xD;
      develops evidence of progression of recurrence, they may undergo further monthly 5-FU or&#xD;
      bevacizumab injections at the discretion of the treating physician.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Funding not received.&#xD;
  </why_stopped>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 1, 2020</primary_completion_date>
  <phase>Phase 4</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>patients, physicians and evaluators will be masked as to the assignment arm.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence</measure>
    <time_frame>3 months</time_frame>
    <description>Recurrence of fibrovascular growth greater than or equal to 1mm onto cornea in area of excised pterygium as judged from slit lamp photographs by masked graders.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence</measure>
    <time_frame>6 months</time_frame>
    <description>Recurrence of fibrovascular growth greater than or equal to 1mm onto cornea in area of excised pterygium as judged from slit lamp photographs by masked graders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence</measure>
    <time_frame>12 months</time_frame>
    <description>Recurrence of fibrovascular growth greater than or equal to 1mm onto cornea in area of excised pterygium as judged from slit lamp photographs by masked graders.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Pterygium of Conjunctiva and Cornea</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will receive 0.1mL of normal saline injected subconjunctival in the area of the excised pterygium and 1 and 2 months postoperative.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5-Fluorouracil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive 0.1mL of 5-Fluorouracil, 5mg/0.1mL, injected subconjunctival in the area of the excised pterygium and 1 and 2 months postoperative.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bevacizumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive 0.1mL of bevacizumab, 2.5mg/0.1mL, injected subconjunctival in the area of the excised pterygium and 1 and 2 months postoperative.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5-Fluorouracil</intervention_name>
    <description>5-fluorouracil is an antimetabolite that is commonly used in glaucoma surgery to prevent postoperative scaring.</description>
    <arm_group_label>5-Fluorouracil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bevacizumab</intervention_name>
    <description>Bevacizumab is an anti-VEGF antibody that is commonly used to prevent or treat neovascularization in retinal disorders.</description>
    <arm_group_label>Bevacizumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>Normal saline will be used as the placebo.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with symptomatic single-headed primary pterygia extending 2mm or more onto&#xD;
             the cornea and determined by the physician to be a good candidate for surgical&#xD;
             excision.&#xD;
&#xD;
          -  Able to express a basic understanding of the study as determined by the treating&#xD;
             physician.&#xD;
&#xD;
          -  Age 18 and older.&#xD;
&#xD;
          -  Commitment to return for follow up visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are pregnant or who are planning on becoming pregnant during the study&#xD;
             period&#xD;
&#xD;
          -  Patients who are unable to tolerate subconjunctival injections in the clinic setting&#xD;
&#xD;
          -  Patients with a diagnosis of glaucoma who are on more than 1 topical medication to&#xD;
             control their intraocular pressure or who have ocular hypertension with a pressure of&#xD;
             greater than or equal to 24mmHg.&#xD;
&#xD;
          -  Patients with a previous history of conjunctival surgery in the eye with the pterygium&#xD;
&#xD;
          -  Patients with a history of autoimmune or inflammatory conjunctival or corneal&#xD;
             disorders, including but not limited to Stevens Johnson syndrome, graft versus host&#xD;
             disease, mucous membrane pemphigoid, severe atopy, and herpes simplex epitheliitis or&#xD;
             keratitis.&#xD;
&#xD;
          -  Patients with an allergy to one or more of the study drugs.&#xD;
&#xD;
          -  Patients who are on systemic immunosuppressive therapy or chemotherapy.&#xD;
&#xD;
          -  Patients with a condition requiring topical steroid drops in the study eye or oral&#xD;
             prednisone at a dose of more than 5mg/day.&#xD;
&#xD;
          -  Patients with a history of scleritis or other severe ocular surface disease such as&#xD;
             limbal stem cell deficiency.&#xD;
&#xD;
          -  Patients with poor vision (defined as VA 20/200 or worse) in the contralateral eye.&#xD;
&#xD;
          -  Patients with a large pterygium judged clinically to need amniotic membrane rather&#xD;
             than a conjunctival autograft.&#xD;
&#xD;
          -  Patients with bi-headed pterygia.&#xD;
&#xD;
          -  Patients unable to undergo conjunctival autograft for any reason.&#xD;
&#xD;
          -  Patients who are unable to give informed consent.&#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>Julie Schallhorn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>August 5, 2021</last_update_submitted>
  <last_update_submitted_qc>August 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 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>Pterygium</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bevacizumab</mesh_term>
    <mesh_term>Fluorouracil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03037736
org study id: OPPS
nct id: NCT03037736
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a randomized controlled trial of postoperative bevacizumab or 5-fluorouracil
      subconjunctival injections vs placebo for the recurrence of pterygia after excision using
      conjunctival autograft.
Patients will be randomized at enrollment to one of three arms: 5-Fluorouracil (5-FU)
      5mg/0.1mL, bevacizumab 2.5mg/0.1mL, or placebo. The placebo will be sterile,
      preservative-free injectable 0.9% normal saline. All patients will undergo pterygium excision
      surgery in the minor procedure room using a standardized surgical technique with conjunctival
      autograft. All patients will have a standardized postoperative drop protocol of
      neomycin/polymyxin/dexamethasone ointment four times daily for 2 weeks and fluorometholone
      drops 4 times daily for 2 weeks, three times daily for 2 weeks, twice daily for 2 weeks, once
      daily for 2 weeks then stopping.

      At the 1-month and 2-month postoperative visits, patients will receive a subconjunctival
      injection based on their randomization assignment (5-FU, bevacizumab or placebo) in the area
      of the excised pterygium at least 1 mm posterior to the limbus. The total injected volume
      will be 0.1mL for all adjuvants.

      The primary outcome will pterygium recurrence at 3 months, defined as evidence of at least 1
      mm of fibrovascular growth onto the cornea. After the 3 month visit, patients who are
      determined to have a recurrence will be unmasked, and can received monthly 5-FU or
      bevacizumab injections at the discretion of the treating physician. Each of these visits will
      be treated as a study visit, and will be documented.

      All patients will have study visits at the 6 and 12 month mark. If at any point any patient
      develops evidence of progression of recurrence, they may undergo further monthly 5-FU or
      bevacizumab injections at the discretion of the treating physician.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: patients, physicians and evaluators will be masked as to the assignment arm.
measure: Recurrence
time frame: 3 months
description: Recurrence of fibrovascular growth greater than or equal to 1mm onto cornea in area of excised pterygium as judged from slit lamp photographs by masked graders.
measure: Recurrence
time frame: 6 months
description: Recurrence of fibrovascular growth greater than or equal to 1mm onto cornea in area of excised pterygium as judged from slit lamp photographs by masked graders.
measure: Recurrence
time frame: 12 months
description: Recurrence of fibrovascular growth greater than or equal to 1mm onto cornea in area of excised pterygium as judged from slit lamp photographs by masked graders.
arm group label: Placebo
arm group type: Placebo Comparator
description: Patients will receive 0.1mL of normal saline injected subconjunctival in the area of the excised pterygium and 1 and 2 months postoperative.
arm group label: 5-Fluorouracil
arm group type: Active Comparator
description: Patients will receive 0.1mL of 5-Fluorouracil, 5mg/0.1mL, injected subconjunctival in the area of the excised pterygium and 1 and 2 months postoperative.
arm group label: Bevacizumab
arm group type: Active Comparator
description: Patients will receive 0.1mL of bevacizumab, 2.5mg/0.1mL, injected subconjunctival in the area of the excised pterygium and 1 and 2 months postoperative.
intervention type: Drug
intervention name: 5-Fluorouracil
description: 5-fluorouracil is an antimetabolite that is commonly used in glaucoma surgery to prevent postoperative scaring.
arm group label: 5-Fluorouracil
intervention type: Drug
intervention name: Bevacizumab
description: Bevacizumab is an anti-VEGF antibody that is commonly used to prevent or treat neovascularization in retinal disorders.
arm group label: Bevacizumab
intervention type: Drug
intervention name: Normal saline
description: Normal saline will be used as the placebo.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Julie Schallhorn, MD
role: Principal Investigator
affiliation: University of California, San Francisco
responsible party type: Sponsor
mesh term: Pterygium
mesh term: Bevacizumab
mesh term: Fluorouracil
sharing ipd: Undecided