<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/NCT02251366</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00088759</org_study_id>
    <nct_id>NCT02251366</nct_id>
  </id_info>
  <brief_title>NVAMD Satellite Study</brief_title>
  <official_title>A Multi-Satellite Comparison of Standard-of-Care, Physician-Based Retinal Evaluation Versus Physician-Guided Diagnostic Evaluation in the Management of Neovascular Age-Related Macular Degeneration With Anti-Vascular Endothelial Growth Factor Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intravitreal delivery of anti-vascular endothelial growth factor (VEGF) drugs has&#xD;
      revolutionized the management of neovascular age-related macular degeneration (NVAMD).&#xD;
      However, the requirement for near monthly administration of therapy coupled with the growing&#xD;
      number of patients needing treatment has become a universal challenge in efficient delivery&#xD;
      of care for retina physicians. While many retina practices have both increased the size of&#xD;
      their staffs to accommodate the growing patient population and increased efficiency with the&#xD;
      aid of digital photography, patient encounter times in clinic continue to increase, often&#xD;
      spanning 2-4 hours. While maintaining the highest level of patient care, a streamlined&#xD;
      alternative in the evaluation of patients with NVAMD to determine whether intravitreal&#xD;
      therapy with an anti-VEGF agent is indicated at a particular office visit would be desirable.&#xD;
&#xD;
      This multi-satellite, prospective, randomized pilot study will compare standard-of-care,&#xD;
      physician- based retinal evaluation, defined as retinal examination by a physician and&#xD;
      standard imaging with optical coherence tomography (OCT) and optional fluorescein angiography&#xD;
      (FA), versus physician-guided diagnostic evaluation, defined as standard imaging with OCT and&#xD;
      optional FA without retinal examination by a physician in the management of NVAMD with&#xD;
      anti-VEGF therapy. Outcomes for this study are aimed primarily at demonstrating that the&#xD;
      physician-guided diagnostic approach to managing patients with NVAMD is not inferior to the&#xD;
      physician-based retinal evaluation based on measures such as a change from baseline in visual&#xD;
      acuity and in central subfield thickness (CSF) on OCT. Other outcomes to be assessed in this&#xD;
      study are length of visit times, numbers of intravitreal injections of anti-VEGF agents&#xD;
      administered, numbers of diagnostic tests performed to determine whether treatment should be&#xD;
      given at each visit, and frequency of retinal examinations performed for each participating&#xD;
      patient in each cohort. Perceptions of quality of vision and patient satisfaction will be&#xD;
      captured by interviews with patients following each clinic visit; clinical impressions of&#xD;
      physicians will be captured by a brief physician survey. Finally, the feasibility of&#xD;
      recruiting patients, as measured by how many eligible patients are seen at each Wilmer&#xD;
      satellite, how many patients agree to be randomized, how many patients follow-up, and the&#xD;
      attrition rates at the 4 and 8-month outcome visits will be assessed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">October 30, 2016</completion_date>
  <primary_completion_date type="Actual">October 30, 2016</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>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in visual acuity from baseline</measure>
    <time_frame>up to two years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in OCT CSF from baseline</measure>
    <time_frame>up to two years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>total encounter time for each arm</measure>
    <time_frame>up to two years</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of intravitreal anti-VEGF injections administered</measure>
    <time_frame>up to two years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>number of diagnostic tests performed</measure>
    <time_frame>up to two years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>number of retinal examinations performed</measure>
    <time_frame>up to two years</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Neovascular Age Related Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>SOC Examination Based Cohort</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this arm will receive standard of care (SOC) retinal examinations at each study visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physician-Guided Diagnostic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this arm of the study will only receive the physical standard-of-care retinal examination at the 4-month and -month office visits, unless requested by the Physician-Investigator or study participant. At each standard study visit, the physician will use diagnostic imaging to determine if the participant will receive the anti-VEGF injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Physician-guided diagnostic</intervention_name>
    <description>NVAMD participants in the physician-guided diagnostic arm will have receive injections based on diagnostic imaging provided by optical coherence tomography and optional fluorescein angiography, those in this group will only receive retinal examinations at the 4- and 8-month clinic visits.</description>
    <arm_group_label>Physician-Guided Diagnostic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Established diagnosis of NVAMD in one or both eyes&#xD;
&#xD;
          -  Received 2 or more intravitreal injections of anti-VEGF therapy from the retinal&#xD;
             physician during the prior 6 months&#xD;
&#xD;
          -  Need for more therapy on a near monthly basis is anticipated&#xD;
&#xD;
          -  Usual corrected visual acuity (UCVA) of at least one eye must be 20/200 or better&#xD;
&#xD;
          -  Must be physically able to cooperate with OCT and other diagnostic imaging procedures&#xD;
&#xD;
          -  Must be able to give informed consent and be able to complete telephone surveys&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Systemic disease that can affect the peripheral retina (e.g., diabetes mellitus,&#xD;
             sickle cell)&#xD;
&#xD;
          -  History of symptomatic posterior vitreous detachment, retinal tear, or retinal&#xD;
             detachment&#xD;
&#xD;
          -  History of retinal surgery will not be enrolled.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sharon Solomon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wilmer Eye Institute</name>
      <address>
        <city>Bel Air</city>
        <state>Maryland</state>
        <zip>21014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilmer Eye Institute</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilmer Eye Institute</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilmer Eye Institute</name>
      <address>
        <city>Frederick</city>
        <state>Maryland</state>
        <zip>21702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilmer Eye Institute</name>
      <address>
        <city>Lutherville</city>
        <state>Maryland</state>
        <zip>21093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>August 28, 2018</last_update_submitted>
  <last_update_submitted_qc>August 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Age-Related Macular Degeneration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
    <mesh_term>Wet Macular Degeneration</mesh_term>
  </condition_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/NCT02251366
org study id: NA_00088759
nct id: NCT02251366
lead sponsor: 
has dmc: Yes
Intravitreal delivery of anti-vascular endothelial growth factor (VEGF) drugs has
      revolutionized the management of neovascular age-related macular degeneration (NVAMD).
      However, the requirement for near monthly administration of therapy coupled with the growing
      number of patients needing treatment has become a universal challenge in efficient delivery
      of care for retina physicians. While many retina practices have both increased the size of
      their staffs to accommodate the growing patient population and increased efficiency with the
      aid of digital photography, patient encounter times in clinic continue to increase, often
      spanning 2-4 hours. While maintaining the highest level of patient care, a streamlined
      alternative in the evaluation of patients with NVAMD to determine whether intravitreal
      therapy with an anti-VEGF agent is indicated at a particular office visit would be desirable.

      This multi-satellite, prospective, randomized pilot study will compare standard-of-care,
      physician- based retinal evaluation, defined as retinal examination by a physician and
      standard imaging with optical coherence tomography (OCT) and optional fluorescein angiography
      (FA), versus physician-guided diagnostic evaluation, defined as standard imaging with OCT and
      optional FA without retinal examination by a physician in the management of NVAMD with
      anti-VEGF therapy. Outcomes for this study are aimed primarily at demonstrating that the
      physician-guided diagnostic approach to managing patients with NVAMD is not inferior to the
      physician-based retinal evaluation based on measures such as a change from baseline in visual
      acuity and in central subfield thickness (CSF) on OCT. Other outcomes to be assessed in this
      study are length of visit times, numbers of intravitreal injections of anti-VEGF agents
      administered, numbers of diagnostic tests performed to determine whether treatment should be
      given at each visit, and frequency of retinal examinations performed for each participating
      patient in each cohort. Perceptions of quality of vision and patient satisfaction will be
      captured by interviews with patients following each clinic visit; clinical impressions of
      physicians will be captured by a brief physician survey. Finally, the feasibility of
      recruiting patients, as measured by how many eligible patients are seen at each Wilmer
      satellite, how many patients agree to be randomized, how many patients follow-up, and the
      attrition rates at the 4 and 8-month outcome visits will be assessed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Change in visual acuity from baseline
time frame: up to two years
measure: Change in OCT CSF from baseline
time frame: up to two years
measure: total encounter time for each arm
time frame: up to two years
measure: Number of intravitreal anti-VEGF injections administered
time frame: up to two years
measure: number of diagnostic tests performed
time frame: up to two years
measure: number of retinal examinations performed
time frame: up to two years
arm group label: SOC Examination Based Cohort
arm group type: No Intervention
description: Participants in this arm will receive standard of care (SOC) retinal examinations at each study visit.
arm group label: Physician-Guided Diagnostic
arm group type: Active Comparator
description: Participants in this arm of the study will only receive the physical standard-of-care retinal examination at the 4-month and -month office visits, unless requested by the Physician-Investigator or study participant. At each standard study visit, the physician will use diagnostic imaging to determine if the participant will receive the anti-VEGF injection.
intervention type: Procedure
intervention name: Physician-guided diagnostic
description: NVAMD participants in the physician-guided diagnostic arm will have receive injections based on diagnostic imaging provided by optical coherence tomography and optional fluorescein angiography, those in this group will only receive retinal examinations at the 4- and 8-month clinic visits.
arm group label: Physician-Guided Diagnostic
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sharon Solomon, MD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Macular Degeneration
mesh term: Wet Macular Degeneration