<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/NCT03261635</url>
  </required_header>
  <id_info>
    <org_study_id>NSAIDs_02</org_study_id>
    <nct_id>NCT03261635</nct_id>
  </id_info>
  <brief_title>Ranibizumab Plus Indomethacin</brief_title>
  <official_title>Prospective Randomized Controlled Trial of Combination Ranibizumab and Indomethacin for Exudative Age-Related Macular Degeneration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università degli Studi di Brescia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Università degli Studi di Brescia</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate whether indomethacin eyedrops plus intravitreal ranibizumab (IVR) provides&#xD;
      additional benefit over IVR monotherapy for treatment of choroidal neovascularization (CNV)&#xD;
      in age-related macular degeneration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2016</start_date>
  <completion_date type="Actual">July 25, 2017</completion_date>
  <primary_completion_date type="Actual">December 7, 2016</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>
    <intervention_model_description>This was a prospective, randomized, pilot study in 58 patients with naï ve CNV. Patients were randomized 1:1 into 2 groups: ranibizumab monotherapy (RM group) and ranibizumab plus indomethacin (RI group). All patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata. RI patients also self- administered one drop of indomethacin three times a day for 12 months. All patients were followed up for 12 months.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Central Retinal Thickness (microns)</measure>
    <time_frame>12-month</time_frame>
    <description>Optical Coherence Tomography will be used to assess central retinal thickness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Acuity (LogMAR)</measure>
    <time_frame>12-month</time_frame>
    <description>ETDRS charts will be used to assess best corrected visual acuity</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Macular Edema</condition>
  <arm_group>
    <arm_group_label>Ranibizumab Monotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ranibizumab + Indomethacin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata. Moreover, patients also self- administered one drop of indomethacin three times a day for 12 months. All patients were followed up for 12 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ranibizumab Injection</intervention_name>
    <description>patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata</description>
    <arm_group_label>Ranibizumab + Indomethacin</arm_group_label>
    <arm_group_label>Ranibizumab Monotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Indomethacin</intervention_name>
    <description>patients self-administered one drop of indomethacin 0.5% eye drops three times a day for 12 months</description>
    <arm_group_label>Ranibizumab + Indomethacin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  provision of written informed consent and compliance with study assessments for the&#xD;
             full duration of the study&#xD;
&#xD;
          -  age &gt; 40 years&#xD;
&#xD;
          -  presence of treatment-naïve neovascular AMD.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any previous intravitreal treatment&#xD;
&#xD;
          -  previous laser treatment in the study eye&#xD;
&#xD;
          -  myopia &gt; 7 diopters in the study eye&#xD;
&#xD;
          -  concurrent eye disease in the study eye that could compromise visual acuity (e.g.,&#xD;
             diabetic retinopathy and advanced glaucoma)&#xD;
&#xD;
          -  concurrent corneal epithelial disruption or any condition that would affect the&#xD;
             ability of the cornea to heal&#xD;
&#xD;
          -  known sensitivity to any component of the formulations being investigated.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 22, 2017</last_update_submitted>
  <last_update_submitted_qc>August 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università degli Studi di Brescia</investigator_affiliation>
    <investigator_full_name>Andrea Russo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Edema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Indomethacin</mesh_term>
    <mesh_term>Ranibizumab</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/NCT03261635
org study id: NSAIDs_02
nct id: NCT03261635
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To evaluate whether indomethacin eyedrops plus intravitreal ranibizumab (IVR) provides
      additional benefit over IVR monotherapy for treatment of choroidal neovascularization (CNV)
      in age-related macular degeneration.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This was a prospective, randomized, pilot study in 58 patients with naï ve CNV. Patients were randomized 1:1 into 2 groups: ranibizumab monotherapy (RM group) and ranibizumab plus indomethacin (RI group). All patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata. RI patients also self- administered one drop of indomethacin three times a day for 12 months. All patients were followed up for 12 months.
primary purpose: Treatment
masking: None (Open Label)
measure: Central Retinal Thickness (microns)
time frame: 12-month
description: Optical Coherence Tomography will be used to assess central retinal thickness.
measure: Visual Acuity (LogMAR)
time frame: 12-month
description: ETDRS charts will be used to assess best corrected visual acuity
arm group label: Ranibizumab Monotherapy
arm group type: Active Comparator
description: All patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata
arm group label: Ranibizumab + Indomethacin
arm group type: Experimental
description: All patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata. Moreover, patients also self- administered one drop of indomethacin three times a day for 12 months. All patients were followed up for 12 months.
intervention type: Drug
intervention name: Ranibizumab Injection
description: patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata
arm group label: Ranibizumab + Indomethacin
arm group label: Ranibizumab Monotherapy
intervention type: Drug
intervention name: Indomethacin
description: patients self-administered one drop of indomethacin 0.5% eye drops three times a day for 12 months
arm group label: Ranibizumab + Indomethacin
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Università degli Studi di Brescia
investigator full name: Andrea Russo
investigator title: Principal Investigator
mesh term: Macular Edema
mesh term: Indomethacin
mesh term: Ranibizumab
sharing ipd: No