<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/NCT03833830</url>
  </required_header>
  <id_info>
    <org_study_id>OCTA 2018-02043</org_study_id>
    <nct_id>NCT03833830</nct_id>
  </id_info>
  <brief_title>Vessel Density in nAMD After Longterm Anti-VEGF Treatment Compared to Recently Started Anti-VEGF Treatment</brief_title>
  <official_title>A Cross Sectional Study Assessing the Perifoveal and Peripapillar Vessel Density in nAMD After Longterm Anti-VEGF Treatment Compared to Recently Started Anti-VEGF Treatment - Pilotstudy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. med. Katja Hatz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cenaug Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vista Klinik</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>
      Neovascular age-related macular degeneration (nAMD) is characterized by the abnormal growth&#xD;
      of blood vessels from the choroid into the subretinal space which leads to sub- and&#xD;
      intraretinal fluid accumulation, hemorrhages and subretinal fibrosis with progressive loss of&#xD;
      central vision. Intravitreal anti-VEGF treatment is the standard of care. Intravitreal&#xD;
      anti-VEGF application might temporarily increase intraocular pressure due to a volume effect.&#xD;
      It remains unclear if repeated injections might have an impact on retinal capillary&#xD;
      perfusion. Therefore this study aims to investigate the vascular microcirculation differences&#xD;
      between patients who received longterm intravitreal Anti-VEGF treatment and patients who&#xD;
      recently started Anti-VEGF treatment using Optical Coherence tomography Angiography (OCTA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Main outcome parameters are:&#xD;
&#xD;
        -  Vessel Perfusion Area (%) of central ETDRS subfields and peripapillar region as&#xD;
           evaluated by OCTA (single measurement)&#xD;
&#xD;
        -  Blood flux index(*) of central ETDRS subfields and peripapillar region as evaluated by&#xD;
           OCTA (single measurement).&#xD;
&#xD;
        -  Peripapillary and perifoveal retinal nerve fiber layer (RNFL) thickness (µm) as&#xD;
           evaluated by OCT (single measurement)&#xD;
&#xD;
        -  Intraocular pressure (IOP) (mmHg) (single measurement at study visit) and mean&#xD;
           intraocular pressure during anti-VEGF treatment period (evaluated as mean of all&#xD;
           retrospectively available IOP measures from the beginning of treatment, mmHg)&#xD;
&#xD;
      (*)Blood flux index is automatically calculated by ARI Network as the mean flow intensity in&#xD;
      the vessel area, where the blood flow signal was normalized to 0 to 1 by dividing by the full&#xD;
      dynamic range of blood flow signal intensity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">May 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 2, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Vessel Perfusion Area (%) and Flux index* of central ETDRS subfields and peripapillary region (single measurements at study visit), respectively, in both groups</measure>
    <time_frame>baseline V0</time_frame>
    <description>in both groups (longterm treatment group ( ≥20 intravitreal injections) and shortterm treatment group (&lt;5 intravitreal injections).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peripapillary and perifoveal retinal nerve fiber layer (RNFL) thickness (µm) as evaluated by OCT (single measurement at study visit)</measure>
    <time_frame>baseline V0</time_frame>
    <description>in both groups (longterm treatment group ( ≥20 intravitreal injections) and shortterm treatment group (&lt;5 intravitreal injections).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraocular pressure (IOP) (mmHg) (single measurement at study visit) and mean intraocular pressure during anti-VEGF treatment period (evaluated as mean of all retrospectively available IOP measures from the beginning of treatment, mmHg)</measure>
    <time_frame>baseline V0</time_frame>
    <description>in both groups (longterm treatment group ( ≥20 intravitreal injections) and shortterm treatment group (&lt;5 intravitreal injections).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>weight</measure>
    <time_frame>baseline V0</time_frame>
    <description>weight meassurements in kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>height</measure>
    <time_frame>baseline V0</time_frame>
    <description>height meassurements in cm</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Neovascular Age-related Macular Degeneration</condition>
  <arm_group>
    <arm_group_label>longterm treatment group</arm_group_label>
    <description>previous treatment (before Optical Coherence Tomography angiography (OCTA)) &gt;20 injections</description>
  </arm_group>
  <arm_group>
    <arm_group_label>shortterm treatment group</arm_group_label>
    <description>previous treatment (before Optical Coherence Tomography angiography (OCTA)) &lt; 5 injections</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Optical Coherence Tomography angiography (OCTA)</intervention_name>
    <description>There will be an OCTA measurement (observational study) for both groups. Group allocation will be made due to previous anti-VEGF treatments (longterm treatment group &gt;20 injections and shortterm treatment group &lt; 5 injections).</description>
    <arm_group_label>longterm treatment group</arm_group_label>
    <arm_group_label>shortterm treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive recruitment. All patients from Vista Klinik attending the retina outpatient&#xD;
        clinic, who fulfil the in- and exclusion criteria, will be offered the participation in the&#xD;
        study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To be eligible for participation, patients will be required to&#xD;
&#xD;
          -  have been treated for sub- or juxtafoveal CNV due to nAMD with anti-VEGF intravitreal&#xD;
             injections either for at least 20 times (longterm treatment eyes) or &lt;5 times&#xD;
             (shortterm treatment eyes).&#xD;
&#xD;
          -  give written consent to participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diagnosis of glaucoma/ocular hypertension at baseline of anti-VEGF treatment&#xD;
&#xD;
               -  history of retinal vascular disorders like diabetic retinopathy, retinal&#xD;
                  vein/arterial occlusive disease, uveitis etc.&#xD;
&#xD;
               -  history of papillary disease which might interfere with interpretation of&#xD;
                  peripapillary OCT/OCTA evaluation such as severe tilted disc, parapapillar CNV,&#xD;
                  papillar drusen, optic nerve neuritis, papillar edema etc.&#xD;
&#xD;
               -  inability to perform OCTA examination of sufficient quality.&#xD;
&#xD;
               -  history of any side effects of Tropicamide eye drops&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katja Hatz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vista Klinik Binningen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vista Klinik</name>
      <address>
        <city>Binningen</city>
        <state>Baselland</state>
        <zip>4102</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>September 30, 2019</last_update_submitted>
  <last_update_submitted_qc>September 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Vista Klinik</investigator_affiliation>
    <investigator_full_name>Dr. med. Katja Hatz</investigator_full_name>
    <investigator_title>Head of medical retina department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Degeneration</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>if necessary on request</ipd_description>
  </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/NCT03833830
org study id: OCTA 2018-02043
nct id: NCT03833830
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Neovascular age-related macular degeneration (nAMD) is characterized by the abnormal growth
      of blood vessels from the choroid into the subretinal space which leads to sub- and
      intraretinal fluid accumulation, hemorrhages and subretinal fibrosis with progressive loss of
      central vision. Intravitreal anti-VEGF treatment is the standard of care. Intravitreal
      anti-VEGF application might temporarily increase intraocular pressure due to a volume effect.
      It remains unclear if repeated injections might have an impact on retinal capillary
      perfusion. Therefore this study aims to investigate the vascular microcirculation differences
      between patients who received longterm intravitreal Anti-VEGF treatment and patients who
      recently started Anti-VEGF treatment using Optical Coherence tomography Angiography (OCTA).
Main outcome parameters are:

        -  Vessel Perfusion Area (%) of central ETDRS subfields and peripapillar region as
           evaluated by OCTA (single measurement)

        -  Blood flux index(*) of central ETDRS subfields and peripapillar region as evaluated by
           OCTA (single measurement).

        -  Peripapillary and perifoveal retinal nerve fiber layer (RNFL) thickness (µm) as
           evaluated by OCT (single measurement)

        -  Intraocular pressure (IOP) (mmHg) (single measurement at study visit) and mean
           intraocular pressure during anti-VEGF treatment period (evaluated as mean of all
           retrospectively available IOP measures from the beginning of treatment, mmHg)

      (*)Blood flux index is automatically calculated by ARI Network as the mean flow intensity in
      the vessel area, where the blood flow signal was normalized to 0 to 1 by dividing by the full
      dynamic range of blood flow signal intensity.
observational model: Other
time perspective: Prospective
measure: Vessel Perfusion Area (%) and Flux index* of central ETDRS subfields and peripapillary region (single measurements at study visit), respectively, in both groups
time frame: baseline V0
description: in both groups (longterm treatment group ( ≥20 intravitreal injections) and shortterm treatment group (<5 intravitreal injections).
measure: Peripapillary and perifoveal retinal nerve fiber layer (RNFL) thickness (µm) as evaluated by OCT (single measurement at study visit)
time frame: baseline V0
description: in both groups (longterm treatment group ( ≥20 intravitreal injections) and shortterm treatment group (<5 intravitreal injections).
measure: Intraocular pressure (IOP) (mmHg) (single measurement at study visit) and mean intraocular pressure during anti-VEGF treatment period (evaluated as mean of all retrospectively available IOP measures from the beginning of treatment, mmHg)
time frame: baseline V0
description: in both groups (longterm treatment group ( ≥20 intravitreal injections) and shortterm treatment group (<5 intravitreal injections).
measure: weight
time frame: baseline V0
description: weight meassurements in kg
measure: height
time frame: baseline V0
description: height meassurements in cm
arm group label: longterm treatment group
description: previous treatment (before Optical Coherence Tomography angiography (OCTA)) >20 injections
arm group label: shortterm treatment group
description: previous treatment (before Optical Coherence Tomography angiography (OCTA)) < 5 injections
intervention type: Diagnostic Test
intervention name: Optical Coherence Tomography angiography (OCTA)
description: There will be an OCTA measurement (observational study) for both groups. Group allocation will be made due to previous anti-VEGF treatments (longterm treatment group >20 injections and shortterm treatment group < 5 injections).
arm group label: longterm treatment group
arm group label: shortterm treatment group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Katja Hatz, MD
role: Principal Investigator
affiliation: Vista Klinik Binningen
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: Vista Klinik
investigator full name: Dr. med. Katja Hatz
investigator title: Head of medical retina department
mesh term: Macular Degeneration
sharing ipd: Undecided
ipd description: if necessary on request