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NCT04477707 · ClinicalTrials.gov registry record
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)
A clinical trial, sponsored by Bayer.
- Completed
- Registry status
- 206
- Enrollment target
NCT04477707: Completed study, sponsored by Bayer.
NCT04477707 is a clinical trial that has completed, run by Bayer. The registered enrollment target is 206 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04477707 has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- 206 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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
Interventions
- DRUG Finerenone (BAY94-8862)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2020-07-23 |
| Est. Completion | 2021-06-25 |
What the finished NCT04477707 record still lists
NCT04477707 is an observational study that tracks outcomes without assigning an intervention. The registered 206 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Finerenone (BAY94-8862) is the first listed.
NCT04477707 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04477707 about?
NCT04477707 is a clinical study titled "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)". 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 b...
What is the current status of trial NCT04477707?
This trial is currently completed. The enrollment target is 206 participants. The study started on 2020-07-23. Estimated completion is 2021-06-25.
What interventions are being tested in trial NCT04477707?
The interventions under investigation include: Finerenone (BAY94-8862) (DRUG).
Who is sponsoring clinical trial NCT04477707?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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