<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/NCT04477707</url>
  </required_header>
  <id_info>
    <org_study_id>21311</org_study_id>
    <nct_id>NCT04477707</nct_id>
  </id_info>
  <brief_title>A Study That Uses Data From Routine Eye Examinations of Patients Participating in Studies FIDELIO-DKD and FIGARO-DKD to Explore Whether Finerenone Can Delay the Progression of a Diabetes Complication That Affects the Eyes (Diabetic Retinopathy ,DR)</brief_title>
  <acronym>ReFineDR</acronym>
  <official_title>Observational Study of Routine Ophthalmological Examinations of Patients Included in the 2 Bayer Sponsored Phase 3 Clinical Trials FIDELIO and FIGARO to Investigate the Effect of Finerenone on Delaying the Progression of Diabetic Retinopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</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>
      Diabetic retinopathy (DR) is a diabetes complication caused by damage to the small blood&#xD;
      vessels inside the retina at the back of the eye. Diabetic retinopathy may cause mild vision&#xD;
      problems or eventually blindness. Diabetes is a condition that makes your blood sugar levels&#xD;
      higher than they should be.&#xD;
&#xD;
      In the early stages of diabetic retinopathy - called non-proliferative diabetic retinopathy&#xD;
      (NPDR)- increased blood sugar levels lead to damage to the tiny blood vessels of the retina.&#xD;
      This damage results in small outpouchings of the vessel lumens leading to rupture. At the&#xD;
      same time the blood vessels can leak and making the retina swell and can cause so called&#xD;
      macula edema. In these early stages of DR current treatment to reduce the risk of this eye&#xD;
      complication is focused on controlling blood sugar levels and blood pressure.&#xD;
&#xD;
      Participants in this study have NPDR, Type 2 Diabetes (T2D) and Chronic Kidney Disease (CKD),&#xD;
      a condition in which the kidneys become damaged and do not work as they should. These&#xD;
      participants are already taking part in one of the phase 3 studies (FIDELIO-DKD and&#xD;
      FIGARO-DKD). They study the effect of Finerenone on delaying kidney disease progression and&#xD;
      reducing the risk of events that may cause damage to the heart and blood vessels To learn&#xD;
      more about the effect of Finerenone on diabetic retinopathy, data from routine eye&#xD;
      examinations performed during the two phase 3 studies will be collected and analyzed. All&#xD;
      male and female participants included in this study are at least 18 years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 23, 2020</start_date>
  <completion_date type="Actual">June 25, 2021</completion_date>
  <primary_completion_date type="Actual">June 25, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Progression of non-proliferative diabetic retinopathy (NPDR)</measure>
    <time_frame>After start of treatment until end of Year 2</time_frame>
    <description>Progression of non-proliferative diabetic retinopathy (NPDR) defined by the occurrence of vision-threatening events i.e. proliferative diabetic retinopathy (PDR), diabetic macular edema (DME), anterior segment neovascularization (ASN) until the end of Year 2 after start of treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression of non-proliferative diabetic retinopathy (NPDR)</measure>
    <time_frame>After start of treatment until end of Year 1</time_frame>
    <description>Progression of non-proliferative diabetic retinopathy (NPDR) defined by the occurrence of vision-threatening events i.e. proliferative diabetic retinopathy (PDR), diabetic macular edema (DME), anterior segment neovascularization (ASN) until the end of Year 1 after start of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression of non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR)</measure>
    <time_frame>After start of treatment until end of Year 1 and end of Year 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of diabetic macular edema (DME)</measure>
    <time_frame>After start of treatment until end of Year 1 and end of Year 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of anterior segment neovascularization (ASN)</measure>
    <time_frame>After start of treatment until end of Year 1 and end of Year 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in severity of diabetic retinopathy (DR)</measure>
    <time_frame>From strat of treatment to the end of Year 1 and end of Year 2</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">206</enrollment>
  <condition>Diabetic Retinopathy</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <description>Patients received treatment in phase 3 clinical trials FIDELIO or FIGARO.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <description>Patients received placebo in phase 3 clinical trials FIDELIO or FIGARO.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Finerenone (BAY94-8862)</intervention_name>
    <description>10 mg or 20 mg Finerenone tablet to be given orally, once daily, administered in the FIDELIO or FIGARO clinical trial.</description>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Cohort of patients included in FIDELIO or FIGARO with NPDR. Patients with at least one&#xD;
        routine ophthalmological assessment available at baseline in FIDELIO or FIGARO, and one&#xD;
        additional measurement at a later time point.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent to participate in ReFineDR&#xD;
&#xD;
          -  Included in FIDELIO or FIGARO, and with DR as medical history&#xD;
&#xD;
          -  Documented NPDR in at least one eye, as documented by ophthalmological records within&#xD;
             6 months prior to baseline in FIDELIO or FIGARO, and up to one month after baseline in&#xD;
             FIDELIO or FIGARO&#xD;
&#xD;
          -  An ophthalmological assessment available 6 month before or maximum 1 month after the&#xD;
             baseline examination in FIDELIO or FIGARO, and at least one additional assessment&#xD;
             afterwards.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with PDR, macular edema or anterior segment complications present at baseline&#xD;
             in FIDELIO or FIGARO in at least one eye.&#xD;
&#xD;
          -  Patients with any documentation of prior or planned retinal laser treatment,&#xD;
             intravitreal injection or vitrectomy at baseline in FIDELIO or FIGARO in at least one&#xD;
             eye.&#xD;
&#xD;
          -  Patients with any other retinal disease documented at baseline in FIDELIO or FIGARO in&#xD;
             at least one eye that would likely interfere with the study objectives (e.g.&#xD;
             neovascular age-related macular degeneration or retinal vein occlusion).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>California Institute of Renal Research - Chula Vista</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Institute of Renal Research, Inc. - El Centro</name>
      <address>
        <city>El Centro</city>
        <state>California</state>
        <zip>92243</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elixia at Florida Kidney Physicians Southeast</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John H Stroger Jr. Hospital of Cook County</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Crescent City Clinical Research Center, LLC</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Joslin Diabetes Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas City VA Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Office of Osvaldo A. Brusco, MD</name>
      <address>
        <city>Corpus Christi</city>
        <state>Texas</state>
        <zip>78414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedResearch, Inc.</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79902-4672</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Advancement Center, PLLC</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78212-4740</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Médico Viamonte</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires</state>
        <zip>C1120AAC</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigación Médica Lanús</name>
      <address>
        <city>Lanús</city>
        <state>Buenos Aires</state>
        <zip>B1824KAJ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Privado de la Comunidad</name>
      <address>
        <city>Mar del Plata</city>
        <state>Buenos Aires</state>
        <zip>B7602CBM</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigación Clínica Aplicada</name>
      <address>
        <city>Ciudad Autón. de Buenos Aires</city>
        <state>Ciudad Auton. De Buenos Aires</state>
        <zip>C1425AGC</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salud renal</name>
      <address>
        <city>San Luis</city>
        <zip>D5702AAx</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huai'an First People's Hospital, Nanjing Medical University</name>
      <address>
        <city>Huai'An</city>
        <state>Jiangsu</state>
        <zip>223300</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Nanjing Medical university</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Diabetes Cardiovascular IPS Ltda.</name>
      <address>
        <city>Barranquilla</city>
        <state>Atlántico</state>
        <zip>0</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aalborg Universitetshospital</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus Universitetshospital, Skejby</name>
      <address>
        <city>Aarhus N</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Steno Diabetes Center Copenhagen</name>
      <address>
        <city>Gentofte</city>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holbæk Sygehus</name>
      <address>
        <city>Holbæk</city>
        <zip>4300</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holstebro Hospital, Endocrinology dept.</name>
      <address>
        <city>Holstebro</city>
        <zip>DK-7500</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viborg Sygehus</name>
      <address>
        <city>Viborg</city>
        <zip>8800</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Mary Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Hospital Hong Kong</name>
      <address>
        <city>Shatin</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edith Wolfson Medical Center</name>
      <address>
        <city>Holon</city>
        <zip>5822012</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center</name>
      <address>
        <city>Kfar Saba</city>
        <zip>4428164</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clalit Health Services, Midgal Hamea</name>
      <address>
        <city>Tel Aviv</city>
        <zip>6203854</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Bergamo Ovest</name>
      <address>
        <city>Bergamo</city>
        <state>Lombardia</state>
        <zip>24047</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASL TO5</name>
      <address>
        <city>Torino</city>
        <state>Piemonte</state>
        <zip>10023</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuoka University Chikushi Hospital</name>
      <address>
        <city>Chikushino</city>
        <state>Fukuoka</state>
        <zip>818-8502</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Steel Memorial Yawata Hospital</name>
      <address>
        <city>Kitakyushu</city>
        <state>Fukuoka</state>
        <zip>805-8508</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hirohata Naika Clinic</name>
      <address>
        <city>Kitakyushu</city>
        <state>Fukuoka</state>
        <zip>807-0857</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical corporation Yamagata Naika Clinic</name>
      <address>
        <city>Asahikawa</city>
        <state>Hokkaido</state>
        <zip>078-8234</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Naka Kinen Clinic</name>
      <address>
        <city>Naka</city>
        <state>Ibaraki</state>
        <zip>311-0113</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shonan Fujisawa Tokushukai Hospital</name>
      <address>
        <city>Fujisawa</city>
        <state>Kanagawa</state>
        <zip>251-0041</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sasebo Chuo Hospital</name>
      <address>
        <city>Sasebo</city>
        <state>Nagasaki</state>
        <zip>857-1195</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukui Prefectural Hospital</name>
      <address>
        <city>Fukui</city>
        <zip>910-8526</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka General Medical Center</name>
      <address>
        <city>Osaka</city>
        <zip>558-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kangnam Sacred Heart Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>07441</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APDP</name>
      <address>
        <city>Lisboa</city>
        <zip>1250-189</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First City Clinical Hospital n.a. E.E. Volosevich</name>
      <address>
        <city>Arkhangelsk</city>
        <zip>163001</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kemerovo Regional Clinical Hospital</name>
      <address>
        <city>Kemerovo</city>
        <zip>650066</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krasnoyarsk Clinical Hospital n.a. N.S. Karpovich</name>
      <address>
        <city>Krasnoyarsk</city>
        <zip>660062</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PHI &quot;Central Clinical Hospital &quot;RZD-Medicine&quot;</name>
      <address>
        <city>Moscow</city>
        <zip>129128</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital #13 Nizhny Novgorod</name>
      <address>
        <city>Nizhny Novgorod</city>
        <zip>603018</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novosibirsk State Medical University</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630091</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saratov City Clinical Hospital #9</name>
      <address>
        <city>Saratov</city>
        <zip>410030</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Voronezh Regional Clinical Consultancy-Diagnostic Center</name>
      <address>
        <city>Voronezh</city>
        <zip>394018</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Outpatient Clinic #4</name>
      <address>
        <city>Voronezh</city>
        <zip>394077</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital SAS de Jerez de la Frontera</name>
      <address>
        <city>Jerez de la Frontera</city>
        <state>Cádiz</state>
        <zip>11407</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de las Nieves|Medicina Interna</name>
      <address>
        <city>Granada</city>
        <zip>18014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akademiska Sjukhuset Njurmottagningen</name>
      <address>
        <city>Uppsala</city>
        <zip>751 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avdelningen för kliniska prövningar AKP</name>
      <address>
        <city>Örebro</city>
        <zip>703 62</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital Kaohsiung</name>
      <address>
        <city>Kaohsiung</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Far Eastern Memorial Hospital</name>
      <address>
        <city>New Taipei City</city>
        <zip>220</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Medical University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>110</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>China</country>
    <country>Colombia</country>
    <country>Denmark</country>
    <country>Hong Kong</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Portugal</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Brazil</country>
    <country>Bulgaria</country>
  </removed_countries>
  <link>
    <url>http://clinicaltrials.bayer.com/</url>
    <description>Click here to find results for studies related to Bayer products</description>
  </link>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>June 24, 2022</last_update_submitted>
  <last_update_submitted_qc>June 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinal Diseases</mesh_term>
    <mesh_term>Diabetic Retinopathy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA &quot;Principles for responsible clinical trial data sharing&quot;. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.</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/NCT04477707
org study id: 21311
nct id: NCT04477707
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Diabetic retinopathy (DR) is a diabetes complication caused by damage to the small blood
      vessels inside the retina at the back of the eye. Diabetic retinopathy may cause mild vision
      problems or eventually blindness. Diabetes is a condition that makes your blood sugar levels
      higher than they should be.

      In the early stages of diabetic retinopathy - called non-proliferative diabetic retinopathy
      (NPDR)- increased blood sugar levels lead to damage to the tiny blood vessels of the retina.
      This damage results in small outpouchings of the vessel lumens leading to rupture. At the
      same time the blood vessels can leak and making the retina swell and can cause so called
      macula edema. In these early stages of DR current treatment to reduce the risk of this eye
      complication is focused on controlling blood sugar levels and blood pressure.

      Participants in this study have NPDR, Type 2 Diabetes (T2D) and Chronic Kidney Disease (CKD),
      a condition in which the kidneys become damaged and do not work as they should. These
      participants are already taking part in one of the phase 3 studies (FIDELIO-DKD and
      FIGARO-DKD). They study the effect of Finerenone on delaying kidney disease progression and
      reducing the risk of events that may cause damage to the heart and blood vessels To learn
      more about the effect of Finerenone on diabetic retinopathy, data from routine eye
      examinations performed during the two phase 3 studies will be collected and analyzed. All
      male and female participants included in this study are at least 18 years.
observational model: Cohort
time perspective: Retrospective
measure: Progression of non-proliferative diabetic retinopathy (NPDR)
time frame: After start of treatment until end of Year 2
description: Progression of non-proliferative diabetic retinopathy (NPDR) defined by the occurrence of vision-threatening events i.e. proliferative diabetic retinopathy (PDR), diabetic macular edema (DME), anterior segment neovascularization (ASN) until the end of Year 2 after start of treatment
measure: Progression of non-proliferative diabetic retinopathy (NPDR)
time frame: After start of treatment until end of Year 1
description: Progression of non-proliferative diabetic retinopathy (NPDR) defined by the occurrence of vision-threatening events i.e. proliferative diabetic retinopathy (PDR), diabetic macular edema (DME), anterior segment neovascularization (ASN) until the end of Year 1 after start of treatment
measure: Progression of non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR)
time frame: After start of treatment until end of Year 1 and end of Year 2
measure: Occurrence of diabetic macular edema (DME)
time frame: After start of treatment until end of Year 1 and end of Year 2
measure: Occurrence of anterior segment neovascularization (ASN)
time frame: After start of treatment until end of Year 1 and end of Year 2
measure: Change in severity of diabetic retinopathy (DR)
time frame: From strat of treatment to the end of Year 1 and end of Year 2
arm group label: Treatment group
description: Patients received treatment in phase 3 clinical trials FIDELIO or FIGARO.
arm group label: Placebo group
description: Patients received placebo in phase 3 clinical trials FIDELIO or FIGARO.
intervention type: Drug
intervention name: Finerenone (BAY94-8862)
description: 10 mg or 20 mg Finerenone tablet to be given orally, once daily, administered in the FIDELIO or FIGARO clinical trial.
arm group label: Treatment group
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
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country: Argentina
country: China
country: Colombia
country: Denmark
country: Hong Kong
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Portugal
country: Russian Federation
country: Spain
country: Sweden
country: Taiwan
country: United States
country: Brazil
country: Bulgaria
url: http://clinicaltrials.bayer.com/
description: Click here to find results for studies related to Bayer products
responsible party type: Sponsor
mesh term: Retinal Diseases
mesh term: Diabetic Retinopathy
sharing ipd: Undecided
ipd description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.