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)

Part of paid clinical trials in Chula Vista, California.

Sponsor
Bayer
Study ID
NCT04477707
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 23, 2020
Status verified
Jun 2022
Primary completion
Jun 25, 2021
Completion
Jun 25, 2021

Study Design

Enrollment
206 participants (actual)

Arms

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

Primary Outcome Measure

Progression of non-proliferative diabetic retinopathy (NPDR) [ Time Frame: After start of treatment until end of Year 2 ]

Locations (10)

FacilityCityStateZIPSite coordinators
California Institute of Renal Research - Chula VistaChula VistaCalifornia91910-
California Institute of Renal Research, Inc. - El CentroEl CentroCalifornia92243-
Elixia at Florida Kidney Physicians SoutheastFort LauderdaleFlorida33308-
John H Stroger Jr. Hospital of Cook CountyChicagoIllinois60612-
Crescent City Clinical Research Center, LLCMetairieLouisiana70006-
Joslin Diabetes CenterBostonMassachusetts02215-
Kansas City VA Medical CenterKansas CityMissouri64128-
Office of Osvaldo A. Brusco, MDCorpus ChristiTexas78414-
MedResearch, Inc.El PasoTexas79902-4672-
Clinical Advancement Center, PLLCSan AntonioTexas78212-4740-

Find similar trials in Chula Vista, CA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
California Institute of Renal Research - Chula Vista· Chula Vista, CACalifornia Institute of Renal Research, Inc. - El Centro· El Centro, CAElixia at Florida Kidney Physicians Southeast· Fort Lauderdale, FLJohn H Stroger Jr. Hospital of Cook County· Chicago, ILCrescent City Clinical Research Center, LLC· Metairie, LAJoslin Diabetes Center· Boston, MA

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