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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-10

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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)

NCT04477707

Diabetic Retinopathy

COMPLETED

Fenofibrate for Prevention of DR Worsening

NCT04661358

Diabetic Retinopathy

RECRUITING PHASE3

Effects of Fenofibrate on Endothelial Progenitor Cells in Diabetes

NCT01927315

Diabetes Diabetic Retinopathy

COMPLETED PHASE4

The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye.

NCT01320345

Type 1 Diabetes Mellitus Diabetic Retinopathy Diabetic Nephropathies

ACTIVE_NOT_RECRUITING PHASE3

Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy

NCT00130845

Diabetic Retinopathy

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Retinopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment group

Patients received treatment in phase 3 clinical trials FIDELIO-DKD (16244) and FIGARO-DKD (17530).

Group Type EXPERIMENTAL

Finerenone (BAY94-8862)

Intervention Type DRUG

10 mg or 20 mg Finerenone tablet to be given orally, once daily, administered in the FIDELIO-DKD or FIGARO-DKD clinical trial.

Placebo group

Patients received placebo in phase 3 clinical trials FIDELIO-DKD (16244) and FIGARO-DKD (17530).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo to be taken orally, once daily, administered in the FIDELIO-DKD or FIGARO-DKD clinical trial.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Finerenone (BAY94-8862)

10 mg or 20 mg Finerenone tablet to be given orally, once daily, administered in the FIDELIO-DKD or FIGARO-DKD clinical trial.

Intervention Type DRUG

Placebo

Matching placebo to be taken orally, once daily, administered in the FIDELIO-DKD or FIGARO-DKD clinical trial.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No