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) (ReFineDR)

June 24, 2022 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

206

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • San Luis, Argentina, D5702AAx
        • Salud renal
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1120AAC
        • Centro Médico Viamonte
      • Lanús, Buenos Aires, Argentina, B1824KAJ
        • Centro de Investigación Médica Lanús
      • Mar del Plata, Buenos Aires, Argentina, B7602CBM
        • Hospital Privado de La Comunidad
    • Ciudad Auton. De Buenos Aires
      • Ciudad Autón. de Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1425AGC
        • Investigacion Clinica Aplicada
  • China
    • Jiangsu
      • Huai'An, Jiangsu, China, 223300
        • Huai'an First People's Hospital, Nanjing Medical University
      • Nanjing, Jiangsu, China, 210011
        • The Second Affiliated Hospital of Nanjing Medical University
  • Colombia
    • Atlántico
      • Barranquilla, Atlántico, Colombia
        • Centro de Diabetes Cardiovascular IPS Ltda.
  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg Universitetshospital
      • Aarhus N, Denmark, 8200
        • Aarhus Universitetshospital, Skejby
      • Gentofte, Denmark, 2730
        • Steno Diabetes Center Copenhagen
      • Holbæk, Denmark, 4300
        • Holbæk Sygehus
      • Holstebro, Denmark, DK-7500
        • Holstebro Hospital, Endocrinology dept.
      • Viborg, Denmark, 8800
        • Viborg Sygehus
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Shatin, Hong Kong
        • Prince of Wales Hospital Hong Kong
  • Israel
      • Holon, Israel, 5822012
        • Edith Wolfson Medical Center
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center
      • Tel Aviv, Israel, 6203854
        • Clalit Health Services, Midgal Hamea
  • Italy
    • Lombardia
      • Bergamo, Lombardia, Italy, 24047
        • ASST Bergamo Ovest
    • Piemonte
      • Torino, Piemonte, Italy, 10023
        • ASL TO5
  • Japan
      • Fukui, Japan, 910-8526
        • Fukui Prefectural Hospital
      • Osaka, Japan, 558-8558
        • Osaka General Medical Center
    • Fukuoka
      • Chikushino, Fukuoka, Japan, 818-8502
        • Fukuoka University Chikushi Hospital
      • Kitakyushu, Fukuoka, Japan, 805-8508
        • Steel Memorial Yawata Hospital
      • Kitakyushu, Fukuoka, Japan, 807-0857
        • Hirohata Naika Clinic
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 078-8234
        • Medical corporation Yamagata Naika Clinic
    • Ibaraki
      • Naka, Ibaraki, Japan, 311-0113
        • Naka Kinen Clinic
    • Kanagawa
      • Fujisawa, Kanagawa, Japan, 251-0041
        • Shonan Fujisawa Tokushukai Hospital
    • Nagasaki
      • Sasebo, Nagasaki, Japan, 857-1195
        • Sasebo Chuo Hospital
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 07441
        • KangNam Sacred Heart Hospital
  • Portugal
      • Lisboa, Portugal, 1250-189
        • APDP
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163001
        • First City Clinical Hospital n.a. E.E. Volosevich
      • Kemerovo, Russian Federation, 650066
        • Kemerovo Regional Clinical Hospital
      • Krasnoyarsk, Russian Federation, 660062
        • Krasnoyarsk Clinical Hospital n.a. N.S. Karpovich
      • Moscow, Russian Federation, 129128
        • PHI "Central Clinical Hospital "RZD-Medicine"
      • Nizhny Novgorod, Russian Federation, 603018
        • City Clinical Hospital #13 Nizhny Novgorod
      • Novosibirsk, Russian Federation, 630091
        • Novosibirsk State Medical University
      • Saratov, Russian Federation, 410030
        • Saratov City Clinical Hospital #9
      • Voronezh, Russian Federation, 394018
        • Voronezh Regional Clinical Consultancy-Diagnostic Center
      • Voronezh, Russian Federation, 394077
        • City Outpatient Clinic #4
  • Spain
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves|Medicina Interna
    • Cádiz
      • Jerez de la Frontera, Cádiz, Spain, 11407
        • Hospital SAS de Jerez de la Frontera
  • Sweden
      • Uppsala, Sweden, 751 85
        • Akademiska Sjukhuset Njurmottagningen
      • Örebro, Sweden, 703 62
        • Avdelningen för kliniska prövningar AKP
  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Chang Gung Memorial Hospital Kaohsiung
      • New Taipei City, Taiwan, 220
        • Far Eastern Memorial Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 110
        • Taipei Medical University Hospital
  • United States
    • California
      • Chula Vista, California, United States, 91910
        • California Institute of Renal Research - Chula Vista
      • El Centro, California, United States, 92243
        • California Institute of Renal Research, Inc. - El Centro
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Elixia at Florida Kidney Physicians Southeast
    • Illinois
      • Chicago, Illinois, United States, 60612
        • John H Stroger Jr. Hospital of Cook County
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Crescent City Clinical Research Center, LLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Kansas City VA Medical Center
    • Texas
      • Corpus Christi, Texas, United States, 78414
        • Office of Osvaldo A. Brusco, MD
      • El Paso, Texas, United States, 79902-4672
        • MedResearch, Inc.
      • San Antonio, Texas, United States, 78212-4740
        • Clinical Advancement Center, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cohort of patients included in FIDELIO or FIGARO with NPDR. Patients with at least one routine ophthalmological assessment available at baseline in FIDELIO or FIGARO, and one additional measurement at a later time point.

Description

Inclusion Criteria:

  • Signed informed consent to participate in ReFineDR
  • Included in FIDELIO or FIGARO, and with DR as medical history
  • Documented NPDR in at least one eye, as documented by ophthalmological records within 6 months prior to baseline in FIDELIO or FIGARO, and up to one month after baseline in FIDELIO or FIGARO
  • An ophthalmological assessment available 6 month before or maximum 1 month after the baseline examination in FIDELIO or FIGARO, and at least one additional assessment afterwards.

Exclusion Criteria:

  • Patients with PDR, macular edema or anterior segment complications present at baseline in FIDELIO or FIGARO in at least one eye.
  • Patients with any documentation of prior or planned retinal laser treatment, intravitreal injection or vitrectomy at baseline in FIDELIO or FIGARO in at least one eye.
  • Patients with any other retinal disease documented at baseline in FIDELIO or FIGARO in at least one eye that would likely interfere with the study objectives (e.g. neovascular age-related macular degeneration or retinal vein occlusion).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment group
Patients received treatment in phase 3 clinical trials FIDELIO or FIGARO.
Drug: Finerenone (BAY94-8862)
10 mg or 20 mg Finerenone tablet to be given orally, once daily, administered in the FIDELIO or FIGARO clinical trial.
Placebo group
Patients received placebo in phase 3 clinical trials FIDELIO or FIGARO.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression of non-proliferative diabetic retinopathy (NPDR)
Time Frame: After start of treatment until end of Year 2
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
After start of treatment until end of Year 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression of non-proliferative diabetic retinopathy (NPDR)
Time Frame: After start of treatment until end of Year 1
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
After start of treatment until end of Year 1
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
After start of treatment until end of Year 1 and end of Year 2
Occurrence of diabetic macular edema (DME)
Time Frame: After start of treatment until end of Year 1 and end of Year 2
After start of treatment until end of Year 1 and end of Year 2
Occurrence of anterior segment neovascularization (ASN)
Time Frame: After start of treatment until end of Year 1 and end of Year 2
After start of treatment until end of Year 1 and end of Year 2
Change in severity of diabetic retinopathy (DR)
Time Frame: From strat of treatment to the end of Year 1 and end of Year 2
From strat of treatment to the end of Year 1 and end of Year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2020

Primary Completion (Actual)

June 25, 2021

Study Completion (Actual)

June 25, 2021

Study Registration Dates

First Submitted

July 16, 2020

First Submitted That Met QC Criteria

July 16, 2020

First Posted (Actual)

July 20, 2020

Study Record Updates

Last Update Posted (Actual)

June 29, 2022

Last Update Submitted That Met QC Criteria

June 24, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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