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)
- Registration Number
- NCT04477707
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 206
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Treatment group Finerenone (BAY94-8862) Patients received treatment in phase 3 clinical trials FIDELIO or FIGARO.
- Primary Outcome Measures
Name Time Method Progression of non-proliferative diabetic retinopathy (NPDR) 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
- Secondary Outcome Measures
Name Time Method Progression of non-proliferative diabetic retinopathy (NPDR) 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
Progression of non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR) After start of treatment until end of Year 1 and end of Year 2 Change in severity of diabetic retinopathy (DR) From strat of treatment to the end of Year 1 and end of Year 2 Occurrence of diabetic macular edema (DME) After start of treatment until end of Year 1 and end of Year 2 Occurrence of anterior segment neovascularization (ASN) After start of treatment until end of Year 1 and end of Year 2
Trial Locations
- Locations (62)
John H Stroger Jr. Hospital of Cook County
🇺🇸Chicago, Illinois, United States
Office of Osvaldo A. Brusco, MD
🇺🇸Corpus Christi, Texas, United States
Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States
California Institute of Renal Research - Chula Vista
🇺🇸Chula Vista, California, United States
Elixia at Florida Kidney Physicians Southeast
🇺🇸Fort Lauderdale, Florida, United States
California Institute of Renal Research, Inc. - El Centro
🇺🇸El Centro, California, United States
Kansas City VA Medical Center
🇺🇸Kansas City, Missouri, United States
Clinical Advancement Center, PLLC
🇺🇸San Antonio, Texas, United States
MedResearch, Inc.
🇺🇸El Paso, Texas, United States
Huai'an First People's Hospital, Nanjing Medical University
🇨🇳Huai'An, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical university
🇨🇳Nanjing, Jiangsu, China
Aalborg Universitetshospital
🇩🇰Aalborg, Denmark
Centro de Diabetes Cardiovascular IPS Ltda.
🇨🇴Barranquilla, Atlántico, Colombia
Steno Diabetes Center Copenhagen
🇩🇰Gentofte, Denmark
Holstebro Hospital, Endocrinology dept.
🇩🇰Holstebro, Denmark
Meir Medical Center
🇮🇱Kfar Saba, Israel
ASL TO5
🇮🇹Torino, Piemonte, Italy
Steel Memorial Yawata Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
Medical corporation Yamagata Naika Clinic
🇯🇵Asahikawa, Hokkaido, Japan
Sasebo Chuo Hospital
🇯🇵Sasebo, Nagasaki, Japan
Osaka General Medical Center
🇯🇵Osaka, Japan
Fukui Prefectural Hospital
🇯🇵Fukui, Japan
Kangnam Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
APDP
🇵🇹Lisboa, Portugal
First City Clinical Hospital n.a. E.E. Volosevich
🇷🇺Arkhangelsk, Russian Federation
Kemerovo Regional Clinical Hospital
🇷🇺Kemerovo, Russian Federation
Krasnoyarsk Clinical Hospital n.a. N.S. Karpovich
🇷🇺Krasnoyarsk, Russian Federation
PHI "Central Clinical Hospital "RZD-Medicine"
🇷🇺Moscow, Russian Federation
City Clinical Hospital #13 Nizhny Novgorod
🇷🇺Nizhny Novgorod, Russian Federation
Novosibirsk State Medical University
🇷🇺Novosibirsk, Russian Federation
Saratov City Clinical Hospital #9
🇷🇺Saratov, Russian Federation
Voronezh Regional Clinical Consultancy-Diagnostic Center
🇷🇺Voronezh, Russian Federation
City Outpatient Clinic #4
🇷🇺Voronezh, Russian Federation
Hospital SAS de Jerez de la Frontera
🇪🇸Jerez de la Frontera, Cádiz, Spain
Hospital Universitario Virgen de las Nieves|Medicina Interna
🇪🇸Granada, Spain
Chang Gung Memorial Hospital Kaohsiung
🇨🇳Kaohsiung, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Far Eastern Memorial Hospital
🇨🇳New Taipei City, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Taipei Medical University Hospital
🇨🇳Taipei, Taiwan
Edith Wolfson Medical Center
🇮🇱Holon, Israel
ASST Bergamo Ovest
🇮🇹Bergamo, Lombardia, Italy
Aarhus Universitetshospital, Skejby
🇩🇰Aarhus N, Denmark
Holbæk Sygehus
🇩🇰Holbæk, Denmark
Viborg Sygehus
🇩🇰Viborg, Denmark
Akademiska Sjukhuset Njurmottagningen
🇸🇪Uppsala, Sweden
Avdelningen för kliniska prövningar AKP
🇸🇪Örebro, Sweden
Centro de Investigación Médica Lanús
🇦🇷Lanús, Buenos Aires, Argentina
Clalit Health Services, Midgal Hamea
🇮🇱Tel Aviv, Israel
Fukuoka University Chikushi Hospital
🇯🇵Chikushino, Fukuoka, Japan
Hirohata Naika Clinic
🇯🇵Kitakyushu, Fukuoka, Japan
Hospital Privado de la Comunidad
🇦🇷Mar del Plata, Buenos Aires, Argentina
Crescent City Clinical Research Center, LLC
🇺🇸Metairie, Louisiana, United States
Centro Médico Viamonte
🇦🇷Caba, Buenos Aires, Argentina
Investigación Clínica Aplicada
🇦🇷Ciudad Autón. de Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina
Salud renal
🇦🇷San Luis, Argentina
Shonan Fujisawa Tokushukai Hospital
🇯🇵Fujisawa, Kanagawa, Japan
Naka Kinen Clinic
🇯🇵Naka, Ibaraki, Japan
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Prince of Wales Hospital Hong Kong
🇭🇰Shatin, Hong Kong