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)
Completed
Conditions studied: Diabetic Retinopathy
In brief
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.
Key facts
- Study ID
- NCT04477707
- Run by
- Bayer
- People needed
- 206
- Starts
- 2020-07-23
- Expected to finish
- 2021-06-25
- Last updated by the study team
- 2022-06-29
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- 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 — Lanus, 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
- California Institute of Renal Research - Chula Vista — Chula Vista, California, United States
Full record on ClinicalTrials.gov
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