Ignite Creation Date:
2024-05-06 @ 2:56 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04477707
Status:
COMPLETED
Last Update Posted:
2022-06-29
First Post:
2020-07-16
Brief Title:
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
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ReFineDR
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None