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)

Overview

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.

Full Title of Study: “Observational Study of Routine Ophthalmological Examinations of Patients Included in the 2 Bayer Sponsored Phase 3 Clinical Trials FIDELIO and FIGARO to Investigate the Effect of Finerenone on Delaying the Progression of Diabetic Retinopathy”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: October 29, 2021

Interventions

  • Drug: Finerenone (BAY94-8862)
    • 10 mg or 20 mg Finerenone tablet to be given orally, once daily, administered in the FIDELIO or FIGARO clinical trial.

Arms, Groups and Cohorts

  • Treatment group
    • Patients received treatment in phase 3 clinical trials FIDELIO or FIGARO.
  • Placebo group
    • Patients received placebo in phase 3 clinical trials FIDELIO or FIGARO.

Clinical Trial Outcome Measures

Primary Measures

  • Progression of non-proliferative diabetic retinopathy (NPDR)
    • Time Frame: After start of treatment until end of Year 2
    • Progression of non-proliferative diabetic retinopathy (NPDR) defined by the occurrence of vision-threatening events i.e. proliferative diabetic retinopathy (PDR), diabetic macular edema (DME), anterior segment neovascularization (ASN) until the end of Year 2 after start of treatment

Secondary Measures

  • Progression of non-proliferative diabetic retinopathy (NPDR)
    • Time Frame: After start of treatment until end of Year 1
    • Progression of non-proliferative diabetic retinopathy (NPDR) defined by the occurrence of vision-threatening events i.e. proliferative diabetic retinopathy (PDR), diabetic macular edema (DME), anterior segment neovascularization (ASN) until the end of Year 1 after start of treatment
  • Progression of non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR)
    • Time Frame: After start of treatment until end of Year 1 and end of Year 2
  • Occurrence of diabetic macular edema (DME)
    • Time Frame: After start of treatment until end of Year 1 and end of Year 2
  • Occurrence of anterior segment neovascularization (ASN)
    • Time Frame: After start of treatment until end of Year 1 and end of Year 2
  • Change in severity of diabetic retinopathy (DR)
    • Time Frame: From strat of treatment to the end of Year 1 and end of Year 2

Participating in This Clinical Trial

Inclusion Criteria

  • Signed informed consent to participate in ReFineDR – Included in FIDELIO or FIGARO, 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 or FIGARO, and up to one month after baseline in FIDELIO or FIGARO – 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. Exclusion Criteria:

  • Patients with PDR, macular edema or anterior segment complications present at baseline in FIDELIO or FIGARO in at least one eye. – 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. – 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).

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Bayer Clinical Trials Contact, (+)1-888-84 22937, clinical-trials-contact@bayer.com

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