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)

Diabetic Retinopathy Clinical Trial

— ReFineDR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04477707
• Other study ID #: 21311
• Status: Completed
• Start date: July 23, 2020
• Est. completion date: June 25, 2021

Study information

• Verified date: June 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: June 25, 2021
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

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.

Locations

Country	Name	City	State
Argentina	Centro Médico Viamonte	Caba	Buenos Aires
Argentina	Investigación Clínica Aplicada	Ciudad Autón. de Buenos Aires	Ciudad Auton. De Buenos Aires
Argentina	Centro de Investigación Médica Lanús	Lanús	Buenos Aires
Argentina	Hospital Privado de la Comunidad	Mar del Plata	Buenos Aires
Argentina	Salud renal	San Luis
China	Huai'an First People's Hospital, Nanjing Medical University	Huai'An	Jiangsu
China	The Second Affiliated Hospital of Nanjing Medical university	Nanjing	Jiangsu
Colombia	Centro de Diabetes Cardiovascular IPS Ltda.	Barranquilla	Atlántico
Denmark	Aalborg Universitetshospital	Aalborg
Denmark	Aarhus Universitetshospital, Skejby	Aarhus N
Denmark	Steno Diabetes Center Copenhagen	Gentofte
Denmark	Holbæk Sygehus	Holbæk
Denmark	Holstebro Hospital, Endocrinology dept.	Holstebro
Denmark	Viborg Sygehus	Viborg
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Prince of Wales Hospital Hong Kong	Shatin
Israel	Edith Wolfson Medical Center	Holon
Israel	Meir Medical Center	Kfar Saba
Israel	Clalit Health Services, Midgal Hamea	Tel Aviv
Italy	ASST Bergamo Ovest	Bergamo	Lombardia
Italy	ASL TO5	Torino	Piemonte
Japan	Medical corporation Yamagata Naika Clinic	Asahikawa	Hokkaido
Japan	Fukuoka University Chikushi Hospital	Chikushino	Fukuoka
Japan	Shonan Fujisawa Tokushukai Hospital	Fujisawa	Kanagawa
Japan	Fukui Prefectural Hospital	Fukui
Japan	Hirohata Naika Clinic	Kitakyushu	Fukuoka
Japan	Steel Memorial Yawata Hospital	Kitakyushu	Fukuoka
Japan	Naka Kinen Clinic	Naka	Ibaraki
Japan	Osaka General Medical Center	Osaka
Japan	Sasebo Chuo Hospital	Sasebo	Nagasaki
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Portugal	APDP	Lisboa
Russian Federation	First City Clinical Hospital n.a. E.E. Volosevich	Arkhangelsk
Russian Federation	Kemerovo Regional Clinical Hospital	Kemerovo
Russian Federation	Krasnoyarsk Clinical Hospital n.a. N.S. Karpovich	Krasnoyarsk
Russian Federation	PHI "Central Clinical Hospital "RZD-Medicine"	Moscow
Russian Federation	City Clinical Hospital #13 Nizhny Novgorod	Nizhny Novgorod
Russian Federation	Novosibirsk State Medical University	Novosibirsk
Russian Federation	Saratov City Clinical Hospital #9	Saratov
Russian Federation	City Outpatient Clinic #4	Voronezh
Russian Federation	Voronezh Regional Clinical Consultancy-Diagnostic Center	Voronezh
Spain	Hospital Universitario Virgen de las Nieves|Medicina Interna	Granada
Spain	Hospital SAS de Jerez de la Frontera	Jerez de la Frontera	Cádiz
Sweden	Avdelningen för kliniska prövningar AKP	Örebro
Sweden	Akademiska Sjukhuset Njurmottagningen	Uppsala
Taiwan	Chang Gung Memorial Hospital Kaohsiung	Kaohsiung
Taiwan	Far Eastern Memorial Hospital	New Taipei City
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Taipei Medical University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	John H Stroger Jr. Hospital of Cook County	Chicago	Illinois
United States	California Institute of Renal Research - Chula Vista	Chula Vista	California
United States	Office of Osvaldo A. Brusco, MD	Corpus Christi	Texas
United States	California Institute of Renal Research, Inc. - El Centro	El Centro	California
United States	MedResearch, Inc.	El Paso	Texas
United States	Elixia at Florida Kidney Physicians Southeast	Fort Lauderdale	Florida
United States	Kansas City VA Medical Center	Kansas City	Missouri
United States	Crescent City Clinical Research Center, LLC	Metairie	Louisiana
United States	Clinical Advancement Center, PLLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Argentina,  China,  Colombia,  Denmark,  Hong Kong,  Israel,  Italy,  Japan,  Korea, Republic of,  Portugal,  Russian Federation,  Spain,  Sweden,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 1 after start of treatment	After start of treatment until end of Year 1
Secondary	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
Secondary	Occurrence of diabetic macular edema (DME)		After start of treatment until end of Year 1 and end of Year 2
Secondary	Occurrence of anterior segment neovascularization (ASN)		After start of treatment until end of Year 1 and end of Year 2
Secondary	Change in severity of diabetic retinopathy (DR)		From strat of treatment to the end of Year 1 and end of Year 2

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