Trial Condition(s):
Diabetic Retinopathy
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)
Bayer Identifier:
21311
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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).
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
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Locations California Institute of Renal Research, Inc. - El Centro El Centro, United States, 92243 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Office of Osvaldo A. Brusco, MD Corpus Christi, United States, 78414 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations John H Stroger Jr. Hospital of Cook County Chicago, United States, 60612 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MedResearch, Inc. El Paso, United States, 79902-4672 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Elixia at Florida Kidney Physicians Southeast Ft. Lauderdale, United States, 33308 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations California Institute of Renal Research - Chula Vista Chula Vista, United States, 91910 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinical Advancement Center, PLLC San Antonio, United States, 78212-4740 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Joslin Diabetes Center Boston, United States, 02215 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kansas City VA Medical Center Kansas City, United States, 64128 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Crescent City Clinical Research Center, LLC Metairie, United States, 70006 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Meir Medical Center Kfar Saba, Israel, 4428164 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Edith Wolfson Medical Center Holon, Israel, 5822012 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clalit Health Services, Midgal Hamea Tel Aviv, Israel, 6203854 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro de Diabetes Cardiovascular IPS Ltda. Barranquilla, Colombia, 0 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Salud renal San Luis, Argentina, D5702AAx | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Privado de la Comunidad Mar del Plata, Argentina, B7602CBM | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Médico Viamonte CABA, Argentina, C1120AAC | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro de Investigación Médica Lanús Lanús, Argentina, B1824KAJ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigación Clínica Aplicada Ciudad Autón. de Buenos Aires, Argentina, C1425AGC | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shonan Fujisawa Tokushukai Hospital Fujisawa, Japan, 251-0041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sasebo Chuo Hospital Sasebo, Japan, 857-1195 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hirohata Naika Clinic Kitakyushu, Japan, 807-0857 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Naka Kinen Clinic Naka, Japan, 311-0113 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical corporation Yamagata Naika Clinic Asahikawa, Japan, 078-8234 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Steel Memorial Yawata Hospital Kitakyushu, Japan, 805-8508 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Osaka General Medical Center Osaka, Japan, 558-8558 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chang Gung Memorial Hospital Kaohsiung Kaohsiung, Taiwan, China, 833 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Far Eastern Memorial Hospital New Taipei City, Taiwan, China, 220 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taipei Veterans General Hospital Taipei, Taiwan, China, 11217 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taipei Medical University Hospital Taipei, Taiwan, China, 110 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taichung Veterans General Hospital Taichung, Taiwan, China, 40705 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kemerovo Regional Clinical Hospital Kemerovo, Russia, 650066 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations PHI "Central Clinical Hospital "RZD-Medicine" Moscow, Russia, 129128 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Krasnoyarsk Clinical Hospital n.a. N.S. Karpovich Krasnoyarsk, Russia, 660062 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Voronezh Regional Clinical Consultancy-Diagnostic Center Voronezh, Russia, 394018 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City Outpatient Clinic #4 Voronezh, Russia, 394077 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saratov City Clinical Hospital #9 Saratov, Russia, 410030 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations First City Clinical Hospital n.a. E.E. Volosevich Arkhangelsk, Russia, 163001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City Clinical Hospital #13 Nizhny Novgorod Nizhny Novgorod, Russia, 603018 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Novosibirsk State Medical University Novosibirsk, Russia, 630091 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASL TO5 Torino, Italy, 10023 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Bergamo Ovest Bergamo, Italy, 24047 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Asan Medical Center Seoul, South Korea, 05505 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kangnam Sacred Heart Hospital Seoul, South Korea, 07441 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Holstebro Hospital, Endocrinology dept. Holstebro, Denmark, DK-7500 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Steno Diabetes Center Copenhagen Gentofte, Denmark, 2730 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Viborg Sygehus Viborg, Denmark, 8800 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Holbæk Sygehus Holbæk, Denmark, 4300 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aalborg Universitetshospital Aalborg, Denmark, 9000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Huai'an First People's Hospital, Nanjing Medical University Huai'An, China, 223300 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Second Affiliated Hospital of Nanjing Medical university Nanjing, China, 210011 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations APDP Lisboa, Portugal, 1250-189 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Virgen de las Nieves|Medicina Interna Granada, Spain, 18014 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Aarhus Universitetshospital, Skejby Aarhus N, Denmark, 8200 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Queen Mary Hospital Hong Kong, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fukui Prefectural Hospital Fukui, Japan, 910-8526 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fukuoka University Chikushi Hospital Chikushino, Japan, 818-8502 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Avdelningen för kliniska prövningar AKP Örebro, Sweden, 703 62 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Akademiska Sjukhuset Njurmottagningen Uppsala, Sweden, 751 85 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Prince of Wales Hospital Hong Kong Shatin, Hong Kong, China | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Severance Hospital, Yonsei University Health System Seoul, South Korea, 03722 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital SAS de Jerez de la Frontera Jerez de la Frontera, Spain, 11407 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
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
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
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 treatmentTimeframe: 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 treatmentTimeframe: After start of treatment until end of Year 1
- Progression of non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR)Timeframe: After start of treatment until end of Year 1 and end of Year 2
- Occurrence of diabetic macular edema (DME)Timeframe: After start of treatment until end of Year 1 and end of Year 2
- Occurrence of anterior segment neovascularization (ASN)Timeframe: After start of treatment until end of Year 1 and end of Year 2
- Change in severity of diabetic retinopathy (DR)Timeframe: From strat of treatment to the end of Year 1 and end of Year 2
Additional Information
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