NCT04795726: DeFineDR

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)

Completed NA Last updated 2 November 2022

What this trial tests

NA trial testing Finerenone (BAY94-8862) in Diabetic Retinopathy in 70 participants. Completed in 30 June 2021.

Timeline

10 March 2021

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	Bayer
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	other
Enrollment	70
Start date	10 March 2021
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	11 locations across United Kingdom, Bulgaria

Drugs / interventions tested

• Finerenone (BAY94-8862) — full drug profile →
• Placebo

Conditions studied

• Diabetic Retinopathy — all drugs for Diabetic Retinopathy →

Sponsor

Bayer — full company profile →

Who can join

18 and older, any sex, with Diabetic Retinopathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cardiovascular-renal protective effect and molecular mechanism of finerenone in type 2 diabetic mellitus.
   Lv R, Xu L, Che L, Liu S, et al · · 2023 · cited 30× · PMID 36860374 · DOI 10.3389/fendo.2023.1125693
2. Effect of finerenone on the occurrence of vision-threatening complications in patients with non-proliferative diabetic retinopathy: Pooled analysis of two studies using routine ophthalmological examinations from clinical trial participants (ReFineDR/DeFineDR).
   Rossing P, Garweg JG, Anker SD, Osonoi T, et al · · 2023 · cited 15× · PMID 36331803 · DOI 10.1111/dom.14915
3. Clinical perspective-evolving evidence of mineralocorticoid receptor antagonists in patients with chronic kidney disease and type 2 diabetes.
   Rossing P. · · 2022 · cited 13× · PMID 35529090 · DOI 10.1016/j.kisu.2021.11.005