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)
NCT ID: NCT04477707
Last Updated: 2022-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
206 participants
OBSERVATIONAL
2020-07-23
2021-06-25
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Treatment group
Patients received treatment in phase 3 clinical trials FIDELIO or FIGARO.
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.
No interventions assigned to this group
Interventions
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Finerenone (BAY94-8862)
10 mg or 20 mg Finerenone tablet to be given orally, once daily, administered in the FIDELIO or FIGARO clinical trial.
Eligibility Criteria
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Inclusion Criteria
* 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 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).
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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California Institute of Renal Research - Chula Vista
Chula Vista, California, United States
California Institute of Renal Research, Inc. - El Centro
El Centro, California, United States
Elixia at Florida Kidney Physicians Southeast
Fort Lauderdale, Florida, United States
John H Stroger Jr. Hospital of Cook County
Chicago, Illinois, United States
Crescent City Clinical Research Center, LLC
Metairie, Louisiana, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Kansas City VA Medical Center
Kansas City, Missouri, United States
Office of Osvaldo A. Brusco, MD
Corpus Christi, Texas, United States
MedResearch, Inc.
El Paso, Texas, United States
Clinical Advancement Center, PLLC
San Antonio, Texas, United States
Centro Médico Viamonte
CABA, Buenos Aires, Argentina
Centro de Investigación Médica Lanús
Lanús, Buenos Aires, Argentina
Hospital Privado de la Comunidad
Mar del Plata, Buenos Aires, Argentina
Investigación Clínica Aplicada
Ciudad Autón. de Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Salud renal
San Luis, , Argentina
Huai'an First People's Hospital, Nanjing Medical University
Huai'an, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical university
Nanjing, Jiangsu, China
Centro de Diabetes Cardiovascular IPS Ltda.
Barranquilla, Atlántico, Colombia
Aalborg Universitetshospital
Aalborg, , Denmark
Aarhus Universitetshospital, Skejby
Aarhus N, , Denmark
Steno Diabetes Center Copenhagen
Gentofte Municipality, , Denmark
Holbæk Sygehus
Holbæk, , Denmark
Holstebro Hospital, Endocrinology dept.
Holstebro, , Denmark
Viborg Sygehus
Viborg, , Denmark
Queen Mary Hospital
Hong Kong, , Hong Kong
Prince of Wales Hospital Hong Kong
Shatin, , Hong Kong
Edith Wolfson Medical Center
Holon, , Israel
Meir Medical Center
Kfar Saba, , Israel
Clalit Health Services, Midgal Hamea
Tel Aviv, , Israel
ASST Bergamo Ovest
Bergamo, Lombardy, Italy
ASL TO5
Turin, Piedmont, Italy
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, Japan
Steel Memorial Yawata Hospital
Kitakyushu, Fukuoka, Japan
Hirohata Naika Clinic
Kitakyushu, Fukuoka, Japan
Medical corporation Yamagata Naika Clinic
Asahikawa, Hokkaido, Japan
Naka Kinen Clinic
Naka, Ibaraki, Japan
Shonan Fujisawa Tokushukai Hospital
Fujisawa, Kanagawa, Japan
Sasebo Chuo Hospital
Sasebo, Nagasaki, Japan
Fukui Prefectural Hospital
Fukui, , Japan
Osaka General Medical Center
Osaka, , Japan
APDP
Lisbon, , Portugal
First City Clinical Hospital n.a. E.E. Volosevich
Arkhangelsk, , Russia
Kemerovo Regional Clinical Hospital
Kemerovo, , Russia
Krasnoyarsk Clinical Hospital n.a. N.S. Karpovich
Krasnoyarsk, , Russia
PHI "Central Clinical Hospital "RZD-Medicine"
Moscow, , Russia
City Clinical Hospital #13 Nizhny Novgorod
Nizhny Novgorod, , Russia
Novosibirsk State Medical University
Novosibirsk, , Russia
Saratov City Clinical Hospital #9
Saratov, , Russia
Voronezh Regional Clinical Consultancy-Diagnostic Center
Voronezh, , Russia
City Outpatient Clinic #4
Voronezh, , Russia
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Kangnam Sacred Heart Hospital
Seoul, , South Korea
Hospital SAS de Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
Hospital Universitario Virgen de las Nieves|Medicina Interna
Granada, , Spain
Avdelningen för kliniska prövningar AKP
Örebro, , Sweden
Akademiska Sjukhuset Njurmottagningen
Uppsala, , Sweden
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung City, , Taiwan
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Taipei Medical University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Related Links
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Other Identifiers
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21311
Identifier Type: -
Identifier Source: org_study_id
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