<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/NCT03762226</url>
  </required_header>
  <id_info>
    <org_study_id>72311607</org_study_id>
    <nct_id>NCT03762226</nct_id>
  </id_info>
  <brief_title>Influence of Systemic Parameters in Diabetic Macular Edema - LIPSIA Study</brief_title>
  <official_title>Influence of Systemic Parameters in Diabetic Macular Edema - LIPSIA Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Leipzig</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Leipzig</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>
      This study aims to evaluate the influence and prognostic value of systemic factors (such as&#xD;
      the cardiovascular and metabolic status) on the treatment response to anti-VEGF therapy in&#xD;
      macular edema due to diabetes or retinal vein occlusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study includes patients with macular edema (ME) due to diabetes or retinal vein&#xD;
      occlusion in the need of treatment.&#xD;
&#xD;
      At baseline patients underwent an extensive ophthalmological examination (best-corrected&#xD;
      visual acuity, OCT, OCT-angiography, fluorescein angiography, fundus photography). Besides&#xD;
      that, systemic work-up (including 24h blood pressure measurement, electrocardiogram, and&#xD;
      serological blood testing) is conducted.&#xD;
&#xD;
      Patients underwent routine ME treatment including at least 4 monthly anti-VEGF injections, as&#xD;
      first-line therapy. Further injections will be conducted if needed. Re-treatment criteria&#xD;
      are: persistent intra- and/or subretinal fluid seen on SD-OCT, central subfield thickness &gt;&#xD;
      300 µm. Ophthalmological examination will be repeated at month 3, 6 and month 12. Systemic&#xD;
      work-up will be repeated at month 6.&#xD;
&#xD;
      Primary outcome is the correlation of systemic parameters with functional and anatomical&#xD;
      response at month 6. Secondary outcome is the correlation of systemic parameters with&#xD;
      functional and anatomical response at month 12.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Correlation of systemic factors on functional and anatomical outcome at month 6.</measure>
    <time_frame>6 months</time_frame>
    <description>Correlation between blood pressure and serological Parameters at baseline and visual acuity/central subfield thickness at month 6.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of systemic factors on functional and anatomical outcome at month 12.</measure>
    <time_frame>12 months</time_frame>
    <description>Correlation between blood pressure and serological parameters at baseline and visual acuity/central subfield thickness at month 12.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Diabetic Macular Edema</condition>
  <condition>Macular Edema</condition>
  <condition>Retinal Vein Occlusion</condition>
  <arm_group>
    <arm_group_label>Patient with Macular edema</arm_group_label>
    <description>Patients with clinically significant macular edema due to diabetes or retinal vein occlusion, undergoing at least 4 monthly intravitreal anti-VEGF injections.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anti-VEGF</intervention_name>
    <description>Patients will undergo as part of the routine care 4 monthly anti-VEGF injections.</description>
    <arm_group_label>Patient with Macular edema</arm_group_label>
    <other_name>Intravitreal anti-VEGF injection</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum and heparine blood sample.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with macular edema due to Diabetes or retinal vein occlusion&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt;= 18 years&#xD;
&#xD;
          2. Diagnosis of diabetes mellitus (type 1 or type 2) and/or retinal vein occlusion&#xD;
&#xD;
          3. macular edema causing visual loss, with study eye VA of 0.1 - 1.0 logMAR (20/25 -&#xD;
             20/200 Snellen equivalent)&#xD;
&#xD;
          4. macular edema defined clinically and by retinal thickness of &gt; 300 µm in the central&#xD;
             subfield thickness (CST) with intra +/- subretinal fluid seen on spectral domain&#xD;
             optical coherence tomography&#xD;
&#xD;
          5. last intravitreal treatment &gt; 3 months ago.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. concomitant ocular disease that could cause macular edema (including choroidal&#xD;
             neovascularization from any cause, uveitis or intraocular surgery less than 6 months&#xD;
             ago).&#xD;
&#xD;
          2. any concomitant ocular or neurological condition that could affect Vision except of&#xD;
             cataract.&#xD;
&#xD;
          3. pregnancy.&#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>Matus Rehak, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Leipzig, Department of Ophthalmology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Matus Rehak, MD, PhD</last_name>
    <phone>+493419721650</phone>
    <email>matus.rehak@medizin.uni-leipzig.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Catharina Busch, MD</last_name>
    <phone>+493419721650</phone>
    <email>catharina.busch@medizin.uni-leipzig.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital Leipzig, department of ophthalmology</name>
      <address>
        <city>Leipzig</city>
        <state>Saxony</state>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>November 30, 2018</last_update_submitted>
  <last_update_submitted_qc>November 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Leipzig</investigator_affiliation>
    <investigator_full_name>PD Dr. habil. Matus Rehak</investigator_full_name>
    <investigator_title>Prof. MUDr. Matus Rehak</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Macular Edema</mesh_term>
    <mesh_term>Retinal Vein Occlusion</mesh_term>
    <mesh_term>Edema</mesh_term>
  </condition_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/NCT03762226
org study id: 72311607
nct id: NCT03762226
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the influence and prognostic value of systemic factors (such as
      the cardiovascular and metabolic status) on the treatment response to anti-VEGF therapy in
      macular edema due to diabetes or retinal vein occlusion.
This study includes patients with macular edema (ME) due to diabetes or retinal vein
      occlusion in the need of treatment.

      At baseline patients underwent an extensive ophthalmological examination (best-corrected
      visual acuity, OCT, OCT-angiography, fluorescein angiography, fundus photography). Besides
      that, systemic work-up (including 24h blood pressure measurement, electrocardiogram, and
      serological blood testing) is conducted.

      Patients underwent routine ME treatment including at least 4 monthly anti-VEGF injections, as
      first-line therapy. Further injections will be conducted if needed. Re-treatment criteria
      are: persistent intra- and/or subretinal fluid seen on SD-OCT, central subfield thickness >
      300 µm. Ophthalmological examination will be repeated at month 3, 6 and month 12. Systemic
      work-up will be repeated at month 6.

      Primary outcome is the correlation of systemic parameters with functional and anatomical
      response at month 6. Secondary outcome is the correlation of systemic parameters with
      functional and anatomical response at month 12.
observational model: Cohort
time perspective: Prospective
measure: Correlation of systemic factors on functional and anatomical outcome at month 6.
time frame: 6 months
description: Correlation between blood pressure and serological Parameters at baseline and visual acuity/central subfield thickness at month 6.
measure: Correlation of systemic factors on functional and anatomical outcome at month 12.
time frame: 12 months
description: Correlation between blood pressure and serological parameters at baseline and visual acuity/central subfield thickness at month 12.
arm group label: Patient with Macular edema
description: Patients with clinically significant macular edema due to diabetes or retinal vein occlusion, undergoing at least 4 monthly intravitreal anti-VEGF injections.
intervention type: Drug
intervention name: Anti-VEGF
description: Patients will undergo as part of the routine care 4 monthly anti-VEGF injections.
arm group label: Patient with Macular edema
other name: Intravitreal anti-VEGF injection
Serum and heparine blood sample.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matus Rehak, MD, PhD
role: Principal Investigator
affiliation: University Hospital Leipzig, Department of Ophthalmology
last name: Matus Rehak, MD, PhD
phone: +493419721650
email: matus.rehak@medizin.uni-leipzig.de
last name: Catharina Busch, MD
phone: +493419721650
email: catharina.busch@medizin.uni-leipzig.de
facility: 
status: Recruiting
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Leipzig
investigator full name: PD Dr. habil. Matus Rehak
investigator title: Prof. MUDr. Matus Rehak
mesh term: Macular Edema
mesh term: Retinal Vein Occlusion
mesh term: Edema
sharing ipd: No