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)

Phase 1

• Conditions: Diabetic Retinopathy; MedDRA version: 20.1Level: PTClassification code 10012689Term: Diabetic retinopathySystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-003865-20-BG
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-04
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Progression of non-proliferative diabetic retinopathy (NPDR)<br>2. Progression of non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR)<br>3. Occurrence of diabetic macular edema (DME)<br>4. Occurrence of anterior segment neovascularization (ASN)<br>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<br>2. After start of treatment until end of Year 1 and end of Year 2<br>3. After start of treatment until end of Year 1 and end of Year 2<br>4. After start of treatment until end of Year 1 and end of Year 2<br>5. From start of treatment to the end of Year 1 and end of Year 2