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 collecting Data from routine ophthalmological examinations of patients who were randomized to either finerenone or placebo in the two Bayer-sponsored Phase 3 clinical trials FIDELIO-DKD and FIGARO-DKD to investigate the effect of Finerenone on delaying the progression of Diabetic Retinopathy - DeFineDR

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003865-20-BG

Enrollment

Registered

2021-01-04

Start date

2021-03-02

Completion date

Unknown

Last updated

2022-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy MedDRA version: 20.1 Level: PT Classification code 10012689 Term: Diabetic retinopathy System Organ Class: 10015919 - Eye disorders

Interventions

Product Name: Finerenone Product Code: BAY 94-8862 IR tablet 10 mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Finerenone CAS Number: 1050477-31-0 Current Sponsor code: BAY 94-8862 Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Signed informed consent to participate in this study 2. Included in FIDELIO (2015-000990-11) or FIGARO (2015-000950-39), and with Diabetic Retinopathy as medical history 3. Documented Non Proliferative Diabetic Retinopathy in at least one eye, as documented by ophthalmological records within 6 months prior to baseline in FIDELIO or FIGARO, and up to one month after baseline in FIDELIO or FIGARO 4. An ophthalmological assessment available 6 month before or maximum 1 month after the baseline examination in FIDELIO or FIGARO, and at least one additional assessment afterwards. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 34 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 56

Exclusion criteria

Exclusion criteria: 1. Patients with Proliferative Diabetic Retinopathy, macular edema or anterior segment complications present at baseline in FIDELIO or FIGARO in at least one eye. 2. Patients with any documentation of prior or planned retinal laser treatment, intravitreal injection or vitrectomy at baseline in FIDELIO or FIGARO in at least one eye. 3. Patients with any other retinal disease documented at baseline in FIDELIO or FIGARO in at least one eye that would likely interfere with the study objectives (e.g. neovascular age related macular degeneration or retinal vein occlusion).

Design outcomes

Primary

Measure	Time frame
Main Objective: This study aims to investigate the effect of orally administered Finerenone on the progression of diabetic retinopathy compared to placebo;Secondary Objective: Not Applicable;Primary end point(s): Progression of non-proliferative diabetic retinopathy (NPDR);Timepoint(s) of evaluation of this end point: After start of treatment until end of Year 2	—

Secondary

Measure	Time frame
Secondary end point(s): 1. Progression of non-proliferative diabetic retinopathy (NPDR) 2. Progression of non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR) 3. Occurrence of diabetic macular edema (DME) 4. Occurrence of anterior segment neovascularization (ASN) 5. Change in severity of diabetic retinopathy (DR);Timepoint(s) of evaluation of this end point: 1. After start of treatment until end of Year 1 2. After start of treatment until end of Year 1 and end of Year 2 3. After start of treatment until end of Year 1 and end of Year 2 4. After start of treatment until end of Year 1 and end of Year 2 5. From start of treatment to the end of Year 1 and end of Year 2	—

Measure

Time frame

Secondary end point(s): 1. Progression of non-proliferative diabetic retinopathy (NPDR) 2. Progression of non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR) 3. Occurrence of diabetic macular edema (DME) 4. Occurrence of anterior segment neovascularization (ASN) 5. Change in severity of diabetic retinopathy (DR);Timepoint(s) of evaluation of this end point: 1. After start of treatment until end of Year 1 2. After start of treatment until end of Year 1 and end of Year 2 3. After start of treatment until end of Year 1 and end of Year 2 4. After start of treatment until end of Year 1 and end of Year 2 5. From start of treatment to the end of Year 1 and end of Year 2

—

Countries

Bulgaria, United Kingdom

Contacts

Public ContactBayer Clinical Trials Contact

Bayer AG

clinical-trials-contact@bayer.com004930300139003

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026