<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/NCT03038048</url>
  </required_header>
  <id_info>
    <org_study_id>16-594E</org_study_id>
    <nct_id>NCT03038048</nct_id>
  </id_info>
  <brief_title>30g vs 33g Needle for Intravitreal Injections</brief_title>
  <official_title>Intravitreal Injection Using 33-gauge Versus 30-gauge Needles: Comparison of Patients' Experience</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wills Eye</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mid Atlantic Retina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wills Eye</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      We are comparing the patient experience between the standard 30 g needle to the smaller 33 g&#xD;
      needle for intravitreal injections of ranabizumab or aflibercept for age related macular&#xD;
      degeneration, diabetic macular edema, or retina vein occlusions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized, interventional pilot study, which seeks to compare the&#xD;
      patient experience using 30-gauge versus 33-gauge needle for bilateral same-day intravitreal&#xD;
      injections of ranibizumab or aflibercept for the treatment of wet age-related macular&#xD;
      degeneration (AMD), diabetic macular edema (DME), or macular edema associated with retinal&#xD;
      vein occlusion (RVO). The null hypothesis is that there is no difference in patient&#xD;
      discomfort or pain with the 30-gauge needle compared to the 33-gauge needle.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 27, 2017</start_date>
  <completion_date type="Actual">April 27, 2017</completion_date>
  <primary_completion_date type="Actual">April 27, 2017</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in discomfort between 30g and 33g needle</measure>
    <time_frame>Day 1</time_frame>
    <description>Intravitreal injection study pain questionnaire to evaluate discomfort associated with intravitreal injections</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraocular pressure 5 minutes post injection</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Age Related Macular Degeneration</condition>
  <condition>Diabetic Macular Edema</condition>
  <condition>Retinal Vein Occlusion</condition>
  <arm_group>
    <arm_group_label>33 g needle - right eye</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>33 g needle for intravitreal injection of Lucentis or Eylea for right eye and 30 g needle for left eye</description>
  </arm_group>
  <arm_group>
    <arm_group_label>33 g needle - left eye</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>33 g needle for intravitreal injection of Lucentis or Eylea for left eye and 30 g needle for right eye</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Varying needle size with intravitreal ranibizumab or aflibercept</intervention_name>
    <description>Varying gauge of needle, 33 gauge vs 30 gauge</description>
    <arm_group_label>33 g needle - left eye</arm_group_label>
    <arm_group_label>33 g needle - right eye</arm_group_label>
    <other_name>Lucentis, Eylea</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing bilateral, same-day, intravitreal injections of either ranibizumab&#xD;
             oraflibercept for the diagnosis of wet AMD, DME, or RVO-associated macular edema&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1) Patients who do not receive Betadine ophthalmic solution prior to intravitreal&#xD;
             injection due to documented allergy 2) Patients who are receiving intravitreal&#xD;
             bevacizumab (this medication iscompounded into pre-filled 1-mL tuberculin syringes).&#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>Allen Chiang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mid Atlantic Retina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mid Atlantic Retina- Wills Eye Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</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>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wills Eye</investigator_affiliation>
    <investigator_full_name>MidAtlantic Retina</investigator_full_name>
    <investigator_title>Allen Chiang, MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Macular Edema</mesh_term>
    <mesh_term>Retinal Vein Occlusion</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ranibizumab</mesh_term>
    <mesh_term>Aflibercept</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/NCT03038048
org study id: 16-594E
nct id: NCT03038048
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
We are comparing the patient experience between the standard 30 g needle to the smaller 33 g
      needle for intravitreal injections of ranabizumab or aflibercept for age related macular
      degeneration, diabetic macular edema, or retina vein occlusions.
This is a prospective, randomized, interventional pilot study, which seeks to compare the
      patient experience using 30-gauge versus 33-gauge needle for bilateral same-day intravitreal
      injections of ranibizumab or aflibercept for the treatment of wet age-related macular
      degeneration (AMD), diabetic macular edema (DME), or macular edema associated with retinal
      vein occlusion (RVO). The null hypothesis is that there is no difference in patient
      discomfort or pain with the 30-gauge needle compared to the 33-gauge needle.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Difference in discomfort between 30g and 33g needle
time frame: Day 1
description: Intravitreal injection study pain questionnaire to evaluate discomfort associated with intravitreal injections
measure: Intraocular pressure 5 minutes post injection
time frame: Day 1
arm group label: 33 g needle - right eye
arm group type: Experimental
description: 33 g needle for intravitreal injection of Lucentis or Eylea for right eye and 30 g needle for left eye
arm group label: 33 g needle - left eye
arm group type: Experimental
description: 33 g needle for intravitreal injection of Lucentis or Eylea for left eye and 30 g needle for right eye
intervention type: Procedure
intervention name: Varying needle size with intravitreal ranibizumab or aflibercept
description: Varying gauge of needle, 33 gauge vs 30 gauge
arm group label: 33 g needle - left eye
arm group label: 33 g needle - right eye
other name: Lucentis, Eylea
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Allen Chiang, MD
role: Principal Investigator
affiliation: Mid Atlantic Retina
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Wills Eye
investigator full name: MidAtlantic Retina
investigator title: Allen Chiang, MD
mesh term: Macular Degeneration
mesh term: Macular Edema
mesh term: Retinal Vein Occlusion
mesh term: Ranibizumab
mesh term: Aflibercept
sharing ipd: No