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)

NCT04477707 | Completed

• 1 other identifier: 21311
• Study Type: observational
• Target: 206
• Locations: 15 countries
• Sites: 62

Brief Summary

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.

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• Progression of non-proliferative diabetic retinopathy (NPDR)

  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

  After start of treatment until end of Year 2

Secondary Outcomes (5)

• Progression of non-proliferative diabetic retinopathy (NPDR)

  After start of treatment until end of Year 1

• Progression of non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR)

  After start of treatment until end of Year 1 and end of Year 2

• Occurrence of diabetic macular edema (DME)

  After start of treatment until end of Year 1 and end of Year 2

• Occurrence of anterior segment neovascularization (ASN)

  After start of treatment until end of Year 1 and end of Year 2

• Change in severity of diabetic retinopathy (DR)

  From strat of treatment to the end of Year 1 and end of Year 2

Study Arms (2)

Treatment group

Patients received treatment in phase 3 clinical trials FIDELIO or FIGARO.

Drug: Finerenone (BAY94-8862)

Placebo group

Patients received placebo in phase 3 clinical trials FIDELIO or FIGARO.

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.

Treatment group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cohort of patients included in FIDELIO or FIGARO with NPDR. Patients with at least one routine ophthalmological assessment available at baseline in FIDELIO or FIGARO, and one additional measurement at a later time point.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bayer: lead

Study Sites (62)

California Institute of Renal Research - Chula Vista

Chula Vista, California, 91910, United States

Location

California Institute of Renal Research, Inc. - El Centro

El Centro, California, 92243, United States

Location

Elixia at Florida Kidney Physicians Southeast

Fort Lauderdale, Florida, 33308, United States

Location

John H Stroger Jr. Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Crescent City Clinical Research Center, LLC

Metairie, Louisiana, 70006, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Kansas City VA Medical Center

Kansas City, Missouri, 64128, United States

Location

Office of Osvaldo A. Brusco, MD

Corpus Christi, Texas, 78414, United States

Location

MedResearch, Inc.

El Paso, Texas, 79902-4672, United States

Location

Clinical Advancement Center, PLLC

San Antonio, Texas, 78212-4740, United States

Location

Centro Médico Viamonte

CABA, Buenos Aires, C1120AAC, Argentina

Location

Centro de Investigación Médica Lanús

Lanús, Buenos Aires, B1824KAJ, Argentina

Location

Hospital Privado de la Comunidad

Mar del Plata, Buenos Aires, B7602CBM, Argentina

Location

Investigación Clínica Aplicada

Ciudad Autón. de Buenos Aires, Ciudad Auton. de Buenos Aires, C1425AGC, Argentina

Location

Salud renal

San Luis, D5702AAx, Argentina

Location

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

Huai'an, Jiangsu, 223300, China

Location

The Second Affiliated Hospital of Nanjing Medical university

Nanjing, Jiangsu, 210011, China

Location

Centro de Diabetes Cardiovascular IPS Ltda.

Barranquilla, Atlántico, 0, Colombia

Location

Aalborg Universitetshospital

Aalborg, 9000, Denmark

Location

Aarhus Universitetshospital, Skejby

Aarhus N, 8200, Denmark

Location

Steno Diabetes Center Copenhagen

Gentofte Municipality, 2730, Denmark

Location

Holbæk Sygehus

Holbæk, 4300, Denmark

Location

Holstebro Hospital, Endocrinology dept.

Holstebro, DK-7500, Denmark

Location

Viborg Sygehus

Viborg, 8800, Denmark

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Prince of Wales Hospital Hong Kong

Shatin, Hong Kong

Location

Edith Wolfson Medical Center

Holon, 5822012, Israel

Location

Meir Medical Center

Kfar Saba, 4428164, Israel

Location

Clalit Health Services, Midgal Hamea

Tel Aviv, 6203854, Israel

Location

ASST Bergamo Ovest

Bergamo, Lombardy, 24047, Italy

Location

ASL TO5

Turin, Piedmont, 10023, Italy

Location

Fukuoka University Chikushi Hospital

Chikushino-shi, Fukuoka, 818-8502, Japan

Location

Steel Memorial Yawata Hospital

Kitakyushu, Fukuoka, 805-8508, Japan

Location

Hirohata Naika Clinic

Kitakyushu, Fukuoka, 807-0857, Japan

Location

Medical corporation Yamagata Naika Clinic

Asahikawa, Hokkaido, 078-8234, Japan

Location

Naka Kinen Clinic

Naka, Ibaraki, 311-0113, Japan

Location

Shonan Fujisawa Tokushukai Hospital

Fujisawa, Kanagawa, 251-0041, Japan

Location

Sasebo Chuo Hospital

Sasebo, Nagasaki, 857-1195, Japan

Location

Fukui Prefectural Hospital

Fukui, 910-8526, Japan

Location

Osaka General Medical Center

Osaka, 558-8558, Japan

Location

APDP

Lisbon, 1250-189, Portugal

Location

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

Arkhangelsk, 163001, Russia

Location

Kemerovo Regional Clinical Hospital

Kemerovo, 650066, Russia

Location

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

Krasnoyarsk, 660062, Russia

Location

PHI "Central Clinical Hospital "RZD-Medicine"

Moscow, 129128, Russia

Location

City Clinical Hospital #13 Nizhny Novgorod

Nizhny Novgorod, 603018, Russia

Location

Novosibirsk State Medical University

Novosibirsk, 630091, Russia

Location

Saratov City Clinical Hospital #9

Saratov, 410030, Russia

Location

Voronezh Regional Clinical Consultancy-Diagnostic Center

Voronezh, 394018, Russia

Location

City Outpatient Clinic #4

Voronezh, 394077, Russia

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Kangnam Sacred Heart Hospital

Seoul, 07441, South Korea

Location

Hospital SAS de Jerez de la Frontera

Jerez de la Frontera, Cádiz, 11407, Spain

Location

Hospital Universitario Virgen de las Nieves|Medicina Interna

Granada, 18014, Spain

Location

Avdelningen för kliniska prövningar AKP

Örebro, 703 62, Sweden

Location

Akademiska Sjukhuset Njurmottagningen

Uppsala, 751 85, Sweden

Location

Chang Gung Memorial Hospital Kaohsiung

Kaohsiung City, 833, Taiwan

Location

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

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MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

finerenone

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 20, 2020
• Study Start: July 23, 2020
• Primary Completion: June 25, 2021
• Study Completion: June 25, 2021
• Last Updated: June 29, 2022

Record last verified: 2022-06

Locations

US (10); AR (5); TW (5); IT (2); ES (2); JP (9); RU (9); SE (2); HK (2); DK (6); CN (2); CO (1); IL (3); PT (1); KR (3)