<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/NCT01670162</url>
  </required_header>
  <id_info>
    <org_study_id>VGFT-OD-1220</org_study_id>
    <nct_id>NCT01670162</nct_id>
  </id_info>
  <brief_title>On-label tReatment With Intravitreal Aflibercept injectiOn for Patients With Persistent Pigment epitheliaL Detachments in Neovascular Age Related Macular Degeneration (AMD)</brief_title>
  <acronym>ROLL</acronym>
  <official_title>On-label tReatment With Intravitreal Aflibercept Injection for Patients With Persistent Pigment Epithelial Detachments in Neovascular AMD.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tennessee Retina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Tennessee Retina</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of intravitreal aflibercept&#xD;
      injection in a population of neovascular AMD patients that have been previously treated with&#xD;
      2.0 mg ranibizumab for persistent PEDs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Phase 4 study to evaluate the efficacy and safety of intravitreal aflibercept injection in&#xD;
      a population of neovascular AMD patients that have been previously treated with 2.0 mg&#xD;
      ranibizumab for persistent PEDs (the ROLL study).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">January 2016</completion_date>
  <primary_completion_date type="Anticipated">November 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients with flattening of PED</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Best Corrected Visual Acuity (BCVA)</measure>
    <time_frame>6 month timepoint and 12 month timepoints</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with flattening of PED</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with flattening of PED</measure>
    <time_frame>18 month and 24 month timepoints</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean number of injections needed</measure>
    <time_frame>12 month period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in Optical Coherence Tomography (OCT) central retinal thickness</measure>
    <time_frame>6 month and 12 month timepoints</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients gaining 5 letters or more letters on Early Treatment Diabetic Retinopathy Study (ETDRS) Chart</measure>
    <time_frame>6 month and 12 month timepoint</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in BCVA</measure>
    <time_frame>18 month and 24 month timepoint</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean number of injections</measure>
    <time_frame>during year 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in OCT central retinal thickness</measure>
    <time_frame>18 month and 24 month timepoints</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients gaining 5 letters or more</measure>
    <time_frame>18 month and 24 month timepoints</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence and severity of adverse events</measure>
    <time_frame>24 month period</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Age Related Macular Degeneration</condition>
  <condition>Pigment Epithelial Detachment</condition>
  <arm_group>
    <arm_group_label>3 loading doses, then every 2 months</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will receive 3 monthly intravitreal aflibercept injections followed by mandatory dosing every 3 months. If needed, patients can be treated monthly.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aflibercept</intervention_name>
    <description>Intravitreal Injection 2mg/0.05mL Aflibercept</description>
    <arm_group_label>3 loading doses, then every 2 months</arm_group_label>
    <other_name>VEGF-Trap</other_name>
    <other_name>Eylea</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previous enrollment in the study evaluating 2.0mg ranibizumab (NCT 01189019) without&#xD;
             early study discontinuation. The last treatment* in the study eye should have been&#xD;
             received at least 30 days before enrollment in this study.&#xD;
&#xD;
             **last study treatment of either 1.0mg or 2.0mg ranibizumab&#xD;
&#xD;
          -  Presence of persistent fibrovascular pigment epithelial detachment Willing and able to&#xD;
             comply iwth clinic visits and study related procedures Provide signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with verteporfin, or external beam radiation therapy, or&#xD;
             transpupillary thermotherapy in the study eye.&#xD;
&#xD;
        Previous subfoveal focal laser photocoagulation involving the foveal center in the study&#xD;
        eye.&#xD;
&#xD;
          -  History of vitrectomy, submacular surgery, or other surgical intervention for AMD in&#xD;
             the study eye.&#xD;
&#xD;
          -  Concurrent eye disease in the study eye that could compromise visual acuity (e.g.&#xD;
             diabetic retinopathy, advanced glaucoma).&#xD;
&#xD;
          -  Any concurrent intraocular condition in the study eye (e.g. diabetic retinopathy or&#xD;
             glaucoma) that, in the opinion of the investigator, could either require medical or&#xD;
             surgical intervention during the 12 month study period to prevent or treat visual loss&#xD;
             that might result from that condition, or if allowed to progress untreated, could&#xD;
             likely contribute to loss of at least 2 Snellen equivalent lines of best corrected&#xD;
             visual acuity over the 12 month study period.&#xD;
&#xD;
          -  Active intraocular inflammation (grade trace or above) in the study eye, or history of&#xD;
             idiopathic or auto-immune associated uveitis in either eye.&#xD;
&#xD;
          -  Current vitreous hemorrhage in the study eye.&#xD;
&#xD;
          -  History of rhegmatogenous retinal detachment or macular hole (stage 3 or 4) in the&#xD;
             study eye.&#xD;
&#xD;
          -  Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either&#xD;
             eye.&#xD;
&#xD;
          -  Aphakia, anterior chamber intraocular lens (ACIOL) or unstable posterior chamber&#xD;
             intraocular lens (PCIOL).&#xD;
&#xD;
          -  Uncontrolled glaucoma in the study eye (defined as intraocular pressure equal to or&#xD;
             greater than 30 despite treatment with anti-glaucoma medication).&#xD;
&#xD;
          -  Pregnant or breastfeeding women.&#xD;
&#xD;
          -  Sexually active men* or women of childbearing potential** who are unwilling to&#xD;
             practice adequate contraception during the study (adequate contraception measures&#xD;
             include stable use of oral contraceptives or other prescription pharmaceutical&#xD;
             contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device&#xD;
             (IUD); bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or&#xD;
             jelly, or diaphragm plus contraceptive sponge, foam or jelly).&#xD;
&#xD;
               -  Contraception is not required for men with documented vasectomy. **Postmenopausal&#xD;
                  women must be amenorrheic for at least 12 months in order not to be considered of&#xD;
                  child bearing potential. Pregnancy testing and contraception are not required for&#xD;
                  women with documented hysterectomy or tubal ligation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brandon G Busbee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tennessee Retina, PC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pacific Eye Associates</name>
      <address>
        <city>San Fransisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Retina Associates of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Retina, P.C.</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>October 27, 2014</last_update_submitted>
  <last_update_submitted_qc>October 27, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pigment Epithelium of Eye</keyword>
  <keyword>Wet macular degeneration</keyword>
  <keyword>Macular degeneration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Retinal Detachment</mesh_term>
    <mesh_term>Dissociative Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aflibercept</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/NCT01670162
org study id: VGFT-OD-1220
nct id: NCT01670162
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the efficacy and safety of intravitreal aflibercept
      injection in a population of neovascular AMD patients that have been previously treated with
      2.0 mg ranibizumab for persistent PEDs.
A Phase 4 study to evaluate the efficacy and safety of intravitreal aflibercept injection in
      a population of neovascular AMD patients that have been previously treated with 2.0 mg
      ranibizumab for persistent PEDs (the ROLL study).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of patients with flattening of PED
time frame: 12 months
measure: Mean Change in Best Corrected Visual Acuity (BCVA)
time frame: 6 month timepoint and 12 month timepoints
measure: Proportion of patients with flattening of PED
time frame: 6 months
measure: Proportion of patients with flattening of PED
time frame: 18 month and 24 month timepoints
measure: Mean number of injections needed
time frame: 12 month period
measure: Mean change in Optical Coherence Tomography (OCT) central retinal thickness
time frame: 6 month and 12 month timepoints
measure: Proportion of patients gaining 5 letters or more letters on Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
time frame: 6 month and 12 month timepoint
measure: Mean change in BCVA
time frame: 18 month and 24 month timepoint
measure: Mean number of injections
time frame: during year 2
measure: Mean change in OCT central retinal thickness
time frame: 18 month and 24 month timepoints
measure: Proportion of patients gaining 5 letters or more
time frame: 18 month and 24 month timepoints
measure: Incidence and severity of adverse events
time frame: 24 month period
arm group label: 3 loading doses, then every 2 months
arm group type: Experimental
description: All patients will receive 3 monthly intravitreal aflibercept injections followed by mandatory dosing every 3 months. If needed, patients can be treated monthly.
intervention type: Drug
intervention name: Aflibercept
description: Intravitreal Injection 2mg/0.05mL Aflibercept
arm group label: 3 loading doses, then every 2 months
other name: VEGF-Trap
other name: Eylea
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Brandon G Busbee, MD
role: Principal Investigator
affiliation: Tennessee Retina, PC
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Retinal Detachment
mesh term: Dissociative Disorders
mesh term: Aflibercept