Trial Condition(s):

Diabetic Retinopathy

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) (ReFineDR)

Bayer Identifier:

21311

ClinicalTrials.gov Identifier:

NCT04477707

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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).

Trial Summary

Enrollment Goal
206
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

California Institute of Renal Research, Inc. - El Centro

El Centro, United States, 92243

Status
Completed
 
Locations

Office of Osvaldo A. Brusco, MD

Corpus Christi, United States, 78414

Status
Not yet recruiting
 
Locations

John H Stroger Jr. Hospital of Cook County

Chicago, United States, 60612

Status
Completed
 
Locations

MedResearch, Inc.

El Paso, United States, 79902-4672

Status
Completed
 
Locations

Elixia at Florida Kidney Physicians Southeast

Ft. Lauderdale, United States, 33308

Status
Completed
 
Locations

California Institute of Renal Research - Chula Vista

Chula Vista, United States, 91910

Status
Completed
 
Locations

Clinical Advancement Center, PLLC

San Antonio, United States, 78212-4740

Status
Completed
 
Locations

Joslin Diabetes Center

Boston, United States, 02215

Status
Recruiting
 
Locations

Kansas City VA Medical Center

Kansas City, United States, 64128

Status
Completed
 
Locations

Crescent City Clinical Research Center, LLC

Metairie, United States, 70006

Status
Completed
 
Locations

Meir Medical Center

Kfar Saba, Israel, 4428164

Status
Completed
 
Locations

Edith Wolfson Medical Center

Holon, Israel, 5822012

Status
Completed
 
Locations

Clalit Health Services, Midgal Hamea

Tel Aviv, Israel, 6203854

Status
Completed
 
Locations

Centro de Diabetes Cardiovascular IPS Ltda.

Barranquilla, Colombia, 0

Status
Completed
 
Locations

Salud renal

San Luis, Argentina, D5702AAx

Status
Completed
 
Locations

Hospital Privado de la Comunidad

Mar del Plata, Argentina, B7602CBM

Status
Completed
 
Locations

Centro Médico Viamonte

CABA, Argentina, C1120AAC

Status
Completed
 
Locations

Centro de Investigación Médica Lanús

Lanús, Argentina, B1824KAJ

Status
Completed
 
Locations

Investigación Clínica Aplicada

Ciudad Autón. de Buenos Aires, Argentina, C1425AGC

Status
Completed
 
Locations

Shonan Fujisawa Tokushukai Hospital

Fujisawa, Japan, 251-0041

Status
Completed
 
Locations

Sasebo Chuo Hospital

Sasebo, Japan, 857-1195

Status
Completed
 
Locations

Hirohata Naika Clinic

Kitakyushu, Japan, 807-0857

Status
Completed
 
Locations

Naka Kinen Clinic

Naka, Japan, 311-0113

Status
Completed
 
Locations

Medical corporation Yamagata Naika Clinic

Asahikawa, Japan, 078-8234

Status
Completed
 
Locations

Steel Memorial Yawata Hospital

Kitakyushu, Japan, 805-8508

Status
Completed
 
Locations

Osaka General Medical Center

Osaka, Japan, 558-8558

Status
Completed
 
Locations

Chang Gung Memorial Hospital Kaohsiung

Kaohsiung, Taiwan, China, 833

Status
Completed
 
Locations

Far Eastern Memorial Hospital

New Taipei City, Taiwan, China, 220

Status
Completed
 
Locations

Taipei Veterans General Hospital

Taipei, Taiwan, China, 11217

Status
Completed
 
Locations

Taipei Medical University Hospital

Taipei, Taiwan, China, 110

Status
Completed
 
Locations

Taichung Veterans General Hospital

Taichung, Taiwan, China, 40705

Status
Completed
 
Locations

Kemerovo Regional Clinical Hospital

Kemerovo, Russia, 650066

Status
Active, not recruiting
 
Locations

PHI "Central Clinical Hospital "RZD-Medicine"

Moscow, Russia, 129128

Status
Completed
 
Locations

Krasnoyarsk Clinical Hospital n.a. N.S. Karpovich

Krasnoyarsk, Russia, 660062

Status
Not yet recruiting
 
Locations

Voronezh Regional Clinical Consultancy-Diagnostic Center

Voronezh, Russia, 394018

Status
Completed
 
Locations

City Outpatient Clinic #4

Voronezh, Russia, 394077

Status
Completed
 
Locations

Saratov City Clinical Hospital #9

Saratov, Russia, 410030

Status
Not yet recruiting
 
Locations

First City Clinical Hospital n.a. E.E. Volosevich

Arkhangelsk, Russia, 163001

Status
Completed
 
Locations

City Clinical Hospital #13 Nizhny Novgorod

Nizhny Novgorod, Russia, 603018

Status
Not yet recruiting
 
Locations

Novosibirsk State Medical University

Novosibirsk, Russia, 630091

Status
Completed
 
Locations

ASL TO5

Torino, Italy, 10023

Status
Completed
 
Locations

ASST Bergamo Ovest

Bergamo, Italy, 24047

Status
Completed
 
Locations

Asan Medical Center

Seoul, South Korea, 05505

Status
Completed
 
Locations

Kangnam Sacred Heart Hospital

Seoul, South Korea, 07441

Status
Completed
 
Locations

Holstebro Hospital, Endocrinology dept.

Holstebro, Denmark, DK-7500

Status
Completed
 
Locations

Steno Diabetes Center Copenhagen

Gentofte, Denmark, 2730

Status
Completed
 
Locations

Viborg Sygehus

Viborg, Denmark, 8800

Status
Completed
 
Locations

Holbæk Sygehus

Holbæk, Denmark, 4300

Status
Completed
 
Locations

Aalborg Universitetshospital

Aalborg, Denmark, 9000

Status
Completed
 
Locations

Huai'an First People's Hospital, Nanjing Medical University

Huai'An, China, 223300

Status
Completed
 
Locations

The Second Affiliated Hospital of Nanjing Medical university

Nanjing, China, 210011

Status
Completed
 
Locations

APDP

Lisboa, Portugal, 1250-189

Status
Completed
 
Locations

Hospital Universitario Virgen de las Nieves|Medicina Interna

Granada, Spain, 18014

Status
Completed
 
Locations

Aarhus Universitetshospital, Skejby

Aarhus N, Denmark, 8200

Status
Completed
 
Locations

Queen Mary Hospital

Hong Kong, Hong Kong, China

Status
Completed
 
Locations

Fukui Prefectural Hospital

Fukui, Japan, 910-8526

Status
Completed
 
Locations

Fukuoka University Chikushi Hospital

Chikushino, Japan, 818-8502

Status
Completed
 
Locations

Avdelningen för kliniska prövningar AKP

Örebro, Sweden, 703 62

Status
Completed
 
Locations

Akademiska Sjukhuset Njurmottagningen

Uppsala, Sweden, 751 85

Status
Completed
 
Locations

Prince of Wales Hospital Hong Kong

Shatin, Hong Kong, China

Status
Completed
 
Locations

Severance Hospital, Yonsei University Health System

Seoul, South Korea, 03722

Status
Completed
 
Locations

Hospital SAS de Jerez de la Frontera

Jerez de la Frontera, Spain, 11407

Status
Completed
 

Trial Design