Trial Condition(s):

Diabetic Retinopathy

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) (DeFineDR)

Bayer Identifier:

21618

ClinicalTrials.gov Identifier:

NCT04795726

EudraCT Number:

2020-003865-20

Study Completed

Trial Purpose

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.

Inclusion Criteria
- Signed informed consent to participate in DeFineDR
- Included in FIDELIO-DKD or FIGARO-DKD, 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-DKD or FIGARO-DKD, and up to one month after baseline in FIDELIO-DKD or FIGARO-DKD
- An ophthalmological assessment available 6 month before or maximum 1 month after the baseline examination in FIDELIO-DKD or FIGARO-DKD, and at least one additional assessment afterwards.
Exclusion Criteria
- Participants with PDR, macular edema or anterior segment complications present at baseline in FIDELIO-DKD or FIGARO-DKD in at least one eye.
- Participants with any documentation of prior or planned retinal laser treatment, intravitreal injection or vitrectomy at baseline in FIDELIO-DKD or FIGARO-DKD in at least one eye.
- Participants with any other retinal disease documented at baseline in FIDELIO-DKD or FIGARO-DKD in at least one eye that would likely interfere with the study objectives (e.g. neovascular age-related macular degeneration or retinal vein occlusion).

Trial Summary

Enrollment Goal
70
Trial Dates
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Phase
N/A
Could I receive a placebo?
Yes
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

MCOMH Preventsia-2000

Stara Zagora, Bulgaria, 6000

Status
Completed
 
Locations

Med Centre Diamedical 2013

Dimitrovgrad, Bulgaria, 6400

Status
Completed
 
Locations

MHAT Dr. Bratan Shukerov AD

Smolyan, Bulgaria, 4700

Status
Completed
 
Locations

MHAT Sveta Karidad

Plovdiv, Bulgaria, 4004

Status
Completed
 
Locations

MHAT Hadzhi Dimitar

Sliven, Bulgaria, 8800

Status
Completed
 
Locations

DCC Aleksandrovska

Sofia, Bulgaria, 1431

Status
Completed
 
Locations

MHAT Sveti Pantaleymon - Yambol

Yambol, Bulgaria, 8600

Status
Completed
 
Locations

Royal London Hospital

London, United Kingdom, E1 1BB

Status
Completed
 
Locations

Southmead Hospital

Bristol, United Kingdom, BS10 5NB

Status
Completed
 
Locations

King's College Hospital - NHS Foundation Trust

London, United Kingdom, SE5 9RS

Status
Completed
 
Locations

St Richard's Hospital

Chichester, United Kingdom, PO19 6SE

Status
Completed
 

Trial Design