finerenone (BAY94-8862)
Drug10 mg or 20 mg Finerenone tablet to be given orally, once daily, administered in the FIDELIO-DKD or FIGARO-DKD clinical trial.
NCT Number: NCT04795726
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Med Centre Diamedical 2013, Dimitrovgrad, Bulgaria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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
Time frame: 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
Time frame: After start of treatment until end of Year 1, and until the end of Year 2
Time frame: After start of treatment until end of Year 1 and end of Year 2
Time frame: After start of treatment until end of Year 1 and end of Year 2
Time frame: From strat of treatment to the end of Year 1 and end of Year 2
Severity grade of DR:
No DR NPDR (mild or moderate) NPDR (severe) PDR
Bayer
Industry
A Clinical Trial Collecting Data From Routine Ophthalmological Examinations of Patients Who Were Randomized to Either Finerenone or Placebo in the Two Bayer-sponsored Phase 3 Clinical Trials FIDELIO-DKD and FIGARO-DKD to Investigate the Effect of Finerenone on Delaying the Progression of Diabetic Retinopathy
Acronym: DeFineDR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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