Clinical trial NCT04477707: 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)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-07-20
Enrollment: 206
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Progression of non-proliferative diabetic retinopathy (NPDR)
timeFrame: After start of treatment until end of Year 2
Secondary outcomes:
measure: Progression of non-proliferative diabetic retinopathy (NPDR)
timeFrame: After start of treatment until end of Year 1
measure: Progression of non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR)
timeFrame: After start of treatment until end of Year 1 and end of Year 2
measure: Occurrence of diabetic macular edema (DME)
timeFrame: After start of treatment until end of Year 1 and end of Year 2
measure: Occurrence of anterior segment neovascularization (ASN)
timeFrame: After start of treatment until end of Year 1 and end of Year 2
measure: Change in severity of diabetic retinopathy (DR)
timeFrame: From strat of treatment to the end of Year 1 and end of Year 2
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: California Institute of Renal Research - Chula Vista
state: California
city: El Centro
country: United States
facility: California Institute of Renal Research, Inc. - El Centro
state: California
city: Fort Lauderdale
country: United States
facility: Elixia at Florida Kidney Physicians Southeast
state: Florida
city: Chicago
country: United States
facility: John H Stroger Jr. Hospital of Cook County
state: Illinois
city: Metairie
country: United States
facility: Crescent City Clinical Research Center, LLC
state: Louisiana
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Kansas City
country: United States
facility: Kansas City VA Medical Center
state: Missouri
city: Corpus Christi
country: United States
facility: Office of Osvaldo A. Brusco, MD
state: Texas
city: El Paso
country: United States
facility: MedResearch, Inc.
state: Texas
city: San Antonio
country: United States
facility: Clinical Advancement Center, PLLC
state: Texas
city: Caba
country: Argentina
facility: Centro Médico Viamonte
state: Buenos Aires
city: Lanús
country: Argentina
facility: Centro de Investigación Médica Lanús
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Hospital Privado de la Comunidad
state: Buenos Aires
city: Ciudad Autón. de Buenos Aires
country: Argentina
facility: Investigación Clínica Aplicada
state: Ciudad Auton. De Buenos Aires
city: San Luis
country: Argentina
facility: Salud renal
city: Huai'An
country: China
facility: Huai'an First People's Hospital, Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical university
state: Jiangsu
city: Barranquilla
country: Colombia
facility: Centro de Diabetes Cardiovascular IPS Ltda.
state: Atlántico
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital, Skejby
city: Gentofte
country: Denmark
facility: Steno Diabetes Center Copenhagen
city: Holbæk
country: Denmark
facility: Holbæk Sygehus
city: Holstebro
country: Denmark
facility: Holstebro Hospital, Endocrinology dept.
city: Viborg
country: Denmark
facility: Viborg Sygehus
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital Hong Kong
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Tel Aviv
country: Israel
facility: Clalit Health Services, Midgal Hamea
city: Bergamo
country: Italy
facility: ASST Bergamo Ovest
state: Lombardia
city: Torino
country: Italy
facility: ASL TO5
state: Piemonte
city: Chikushino
country: Japan
facility: Fukuoka University Chikushi Hospital
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Steel Memorial Yawata Hospital
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Hirohata Naika Clinic
state: Fukuoka
city: Asahikawa
country: Japan
facility: Medical corporation Yamagata Naika Clinic
state: Hokkaido
city: Naka
country: Japan
facility: Naka Kinen Clinic
state: Ibaraki
city: Fujisawa
country: Japan
facility: Shonan Fujisawa Tokushukai Hospital
state: Kanagawa
city: Sasebo
country: Japan
facility: Sasebo Chuo Hospital
state: Nagasaki
city: Fukui
country: Japan
facility: Fukui Prefectural Hospital
city: Osaka
country: Japan
facility: Osaka General Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangnam Sacred Heart Hospital
city: Lisboa
country: Portugal
facility: APDP
city: Arkhangelsk
country: Russian Federation
facility: First City Clinical Hospital n.a. E.E. Volosevich
city: Kemerovo
country: Russian Federation
facility: Kemerovo Regional Clinical Hospital
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Clinical Hospital n.a. N.S. Karpovich
city: Moscow
country: Russian Federation
facility: PHI "Central Clinical Hospital "RZD-Medicine"
city: Nizhny Novgorod
country: Russian Federation
facility: City Clinical Hospital #13 Nizhny Novgorod
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Medical University
city: Saratov
country: Russian Federation
facility: Saratov City Clinical Hospital #9
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Consultancy-Diagnostic Center
city: Voronezh
country: Russian Federation
facility: City Outpatient Clinic #4
city: Jerez de la Frontera
country: Spain
facility: Hospital SAS de Jerez de la Frontera
state: Cádiz
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves|Medicina Interna
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset Njurmottagningen
city: Örebro
country: Sweden
facility: Avdelningen för kliniska prövningar AKP
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital Kaohsiung
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: