check_circleStudy Completed
Diabetic Retinopathy
Bayer Identifier:
21311
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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)
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
NaN - N/ATrial summary
Enrollment Goal
206Trial Dates
July 2020 - June 2021Phase
N/ACould I Receive a placebo
NoProducts
Kerendia (Finerenone, BAY94-8862)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Withdrawn | MCOMH Preventsia-2000 | Stara Zagora, 6000, Bulgaria |
Withdrawn | Med Centre Diamedical 2013 | Dimitrovgrad, 6400, Bulgaria |
Withdrawn | MHAT Dr. Bratan Shukerov AD | Smolyan, 4700, Bulgaria |
Withdrawn | MHAT Sveta Karidad | Plovdiv, 4004, Bulgaria |
Withdrawn | DCC Aleksandrovska | Sofia, 1606, Bulgaria |
Completed | California Institute of Renal Research, Inc. - El Centro | El Centro, 92243, United States |
Not yet recruiting | Office of Osvaldo A. Brusco, MD | Corpus Christi, 78414, United States |
Completed | John H Stroger Jr. Hospital of Cook County | Chicago, 60612, United States |
Completed | MedResearch, Inc. | El Paso, 79902-4672, United States |
Withdrawn | Salem VA Medical Center | Salem, 24153, United States |
Completed | Elixia at Florida Kidney Physicians Southeast | Ft. Lauderdale, 33308, United States |
Completed | California Institute of Renal Research - Chula Vista | Chula Vista, 91910, United States |
Completed | Clinical Advancement Center, PLLC | San Antonio, 78212-4740, United States |
Recruiting | Joslin Diabetes Center | Boston, 02215, United States |
Completed | Kansas City VA Medical Center | Kansas City, 64128, United States |
Completed | Crescent City Clinical Research Center, LLC | Metairie, 70006, United States |
Completed | Meir Medical Center | Kfar Saba, 4428164, Israel |
Completed | Edith Wolfson Medical Center | Holon, 5822012, Israel |
Withdrawn | DMC - Diabetes Medical Center | Tel Aviv, 6937947, Israel |
Completed | Clalit Health Services, Midgal Hamea | Tel Aviv, 6203854, Israel |
Withdrawn | Endocare Ltda. | Bogotá, Colombia |
Withdrawn | Caja de Compensación Familiar CAFAM | Bogotá, Colombia |
Completed | Centro de Diabetes Cardiovascular IPS Ltda. | Barranquilla, Colombia |
Withdrawn | MHAT Hadzhi Dimitar | Sliven, 8800, Bulgaria |
Completed | Salud renal | San Luis, D5702AAx, Argentina |
Completed | Hospital Privado de la Comunidad | Mar del Plata, B7602CBM, Argentina |
Withdrawn | Centro de Investigaciones Metabólicas | Buenos Aires, C1056ABJ, Argentina |
Completed | Centro Médico Viamonte | CABA, C1120AAC, Argentina |
Completed | Centro de Investigación Médica Lanús | Lanús, B1824KAJ, Argentina |
Completed | Investigación Clínica Aplicada | Ciudad Autón. de Buenos Aires, C1425AGC, Argentina |
Withdrawn | Centro de Investigaciones Clínicas | CABA, C1018DES, Argentina |
Completed | Shonan Fujisawa Tokushukai Hospital | Fujisawa, 251-0041, Japan |
Completed | Sasebo Chuo Hospital | Sasebo, 857-1195, Japan |
Completed | Hirohata Naika Clinic | Kitakyushu, 807-0857, Japan |
Completed | Naka Kinen Clinic | Naka, 311-0113, Japan |
Completed | Medical corporation Yamagata Naika Clinic | Asahikawa, 078-8234, Japan |
Withdrawn | Sekigami Clinic | Yatsushiro, 866-0824, Japan |
Completed | Steel Memorial Yawata Hospital | Kitakyushu, 805-8508, Japan |
Completed | Osaka General Medical Center | Osaka, 558-8558, Japan |
Completed | Chang Gung Memorial Hospital Kaohsiung | Kaohsiung, 833, Taiwan |
Completed | Far Eastern Memorial Hospital | New Taipei City, 220, Taiwan |
Completed | Taipei Veterans General Hospital | Taipei, 11217, Taiwan |
Completed | Taipei Medical University Hospital | Taipei, 110, Taiwan |
Completed | Taichung Veterans General Hospital | Taichung, 40705, Taiwan |
Active, not recruiting | Kemerovo Regional Clinical Hospital | Kemerovo, 650066, Russian Federation |
Completed | PHI "Central Clinical Hospital "RZD-Medicine" | Moscow, 129128, Russian Federation |
Not yet recruiting | Krasnoyarsk Clinical Hospital n.a. N.S. Karpovich | Krasnoyarsk, 660062, Russian Federation |
Completed | Voronezh Regional Clinical Consultancy-Diagnostic Center | Voronezh, 394018, Russian Federation |
Completed | City Outpatient Clinic #4 | Voronezh, 394077, Russian Federation |
Not yet recruiting | Saratov City Clinical Hospital #9 | Saratov, 410030, Russian Federation |
Completed | First City Clinical Hospital n.a. E.E. Volosevich | Arkhangelsk, 163001, Russian Federation |
Not yet recruiting | City Clinical Hospital #13 Nizhny Novgorod | Nizhny Novgorod, 603018, Russian Federation |
Completed | Novosibirsk State Medical University | Novosibirsk, 630091, Russian Federation |
Completed | ASL TO5 | Torino, 10023, Italy |
Completed | ASST Bergamo Ovest | Bergamo, 24047, Italy |
Completed | Asan Medical Center | Seoul, 05505, Korea, Republic Of |
Completed | Kangnam Sacred Heart Hospital | Seoul, 07441, Korea, Republic Of |
Completed | Holstebro Hospital, Endocrinology dept. | Holstebro, DK-7500, Denmark |
Withdrawn | Sydvestjysk Sygehus Esbjerg | Esbjerg, 6700, Denmark |
Completed | Steno Diabetes Center Copenhagen | Gentofte, 2730, Denmark |
Completed | Viborg Sygehus | Viborg, 8800, Denmark |
Completed | Holbæk Sygehus | Holbæk, 4300, Denmark |
Completed | Aalborg Universitetshospital | Aalborg, 9000, Denmark |
Withdrawn | NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med School | Nanjing, 210008, China |
Completed | Huai'an First People's Hospital, Nanjing Medical University | Huai'An, 223300, China |
Completed | The Second Affiliated Hospital of Nanjing Medical university | Nanjing, 210011, China |
Completed | APDP | Lisboa, 1250-189, Portugal |
Completed | Hospital Universitario Virgen de las Nieves|Medicina Interna | Granada, 18014, Spain |
Withdrawn | Fundação Oswaldo Ramos - Hospital do Rim e Hipertensão | Sao Paulo, 04039-000, Brazil |
Withdrawn | Instituto Brasil de Pesquisa Clínica S/A - IBPClin | Rio de Janeiro, 20241-180, Brazil |
Completed | Aarhus Universitetshospital, Skejby | Aarhus N, 8200, Denmark |
Completed | Queen Mary Hospital | Hong Kong, Hong Kong |
Withdrawn | Fukui-ken Saiseikai Hospital | Fukui, 918-8503, Japan |
Completed | Fukui Prefectural Hospital | Fukui, 910-8526, Japan |
Completed | Fukuoka University Chikushi Hospital | Chikushino, 818-8502, Japan |
Completed | Avdelningen för kliniska prövningar AKP | Örebro, 703 62, Sweden |
Completed | Akademiska Sjukhuset Njurmottagningen | Uppsala, 751 85, Sweden |
Completed | Prince of Wales Hospital Hong Kong | Shatin, Hong Kong |
Completed | Severance Hospital, Yonsei University Health System | Seoul, 03722, Korea, Republic Of |
Completed | Hospital SAS de Jerez de la Frontera | Jerez de la Frontera, 11407, Spain |
Primary Outcome
- Progression of non-proliferative diabetic retinopathy (NPDR)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 treatmentdate_rangeTime Frame:After start of treatment until end of Year 2
Secondary Outcome
- Progression of non-proliferative diabetic retinopathy (NPDR)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 treatmentdate_rangeTime Frame:After start of treatment until end of Year 1
- Progression of non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR)date_rangeTime Frame:After start of treatment until end of Year 1 and end of Year 2
- Occurrence of diabetic macular edema (DME)date_rangeTime Frame:After start of treatment until end of Year 1 and end of Year 2
- Occurrence of anterior segment neovascularization (ASN)date_rangeTime Frame:After start of treatment until end of Year 1 and end of Year 2
- Change in severity of diabetic retinopathy (DR)date_rangeTime Frame:From strat of treatment to the end of Year 1 and end of Year 2
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A