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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
70
10 mg or 20 mg Finerenone tablet to be given orally, once daily, administered in the FIDELIO-DKD or FIGARO-DKD clinical trial.
Matching placebo to be taken orally, once daily, administered in the FIDELIO-DKD or FIGARO-DKD clinical trial.
Med Centre Diamedical 2013
Dimitrovgrad, Bulgaria
MHAT Sveta Karidad
Plovdiv, Bulgaria
MHAT Hadzhi Dimitar
Sliven, Bulgaria
MHAT Dr. Bratan Shukerov AD
Smolyan, Bulgaria
DCC Aleksandrovska
Sofia, Bulgaria
MCOMH Preventsia-2000
Stara Zagora, Bulgaria
MHAT Sveti Pantaleymon - Yambol
Yambol, Bulgaria
Southmead Hospital
Bristol, Avon, United Kingdom
St Richard's Hospital
Chichester, West Sussex, United Kingdom
Royal London Hospital
London, United Kingdom
...and 1 more locations
Proportion of participants with 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 treatment
Time frame: After start of treatment until end of Year 2
Proportion of participants with 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 treatment
Time frame: After start of treatment until end of Year 1
Proportion of participants with progression of NPDR to Proliferative Diabetic Retinopathy (PDR)
Time frame: After start of treatment until end of Year 1, and until the end of Year 2
Proportion of participants with diabetic macular edema (DME)
Time frame: After start of treatment until end of Year 1 and end of Year 2
Proportion of participants with anterior segment neovascularization (ASN)
Time frame: After start of treatment until end of Year 1 and end of Year 2
Change in severity of diabetic retinopathy (DR)
Severity grade of DR: No DR NPDR (mild or moderate) NPDR (severe) PDR
Time frame: From strat of treatment to the end of Year 1 and end of Year 2
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