check_circleStudy Completed

Diabetic Retinopathy

Bayer Identifier:

21311

ClinicalTrials.gov Identifier:

NCT04477707

EudraCT Number:

Not Available

EU CT Number:

Not Available
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)

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.

Key Participants Requirements

Sex

All

Age

NaN - N/A
  • - 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.
  • - 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
July 2020 - June 2021
Phase
N/A
Could I Receive a placebo
No
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
MCOMH Preventsia-2000Stara Zagora, 6000, Bulgaria
Withdrawn
Med Centre Diamedical 2013Dimitrovgrad, 6400, Bulgaria
Withdrawn
MHAT Dr. Bratan Shukerov ADSmolyan, 4700, Bulgaria
Withdrawn
MHAT Sveta KaridadPlovdiv, 4004, Bulgaria
Withdrawn
DCC AleksandrovskaSofia, 1606, Bulgaria
Completed
California Institute of Renal Research, Inc. - El CentroEl Centro, 92243, United States
Not yet recruiting
Office of Osvaldo A. Brusco, MDCorpus Christi, 78414, United States
Completed
John H Stroger Jr. Hospital of Cook CountyChicago, 60612, United States
Completed
MedResearch, Inc.El Paso, 79902-4672, United States
Withdrawn
Salem VA Medical CenterSalem, 24153, United States
Completed
Elixia at Florida Kidney Physicians SoutheastFt. Lauderdale, 33308, United States
Completed
California Institute of Renal Research - Chula VistaChula Vista, 91910, United States
Completed
Clinical Advancement Center, PLLCSan Antonio, 78212-4740, United States
Recruiting
Joslin Diabetes CenterBoston, 02215, United States
Completed
Kansas City VA Medical CenterKansas City, 64128, United States
Completed
Crescent City Clinical Research Center, LLCMetairie, 70006, United States
Completed
Meir Medical CenterKfar Saba, 4428164, Israel
Completed
Edith Wolfson Medical CenterHolon, 5822012, Israel
Withdrawn
DMC - Diabetes Medical CenterTel Aviv, 6937947, Israel
Completed
Clalit Health Services, Midgal HameaTel Aviv, 6203854, Israel
Withdrawn
Endocare Ltda.Bogotá, Colombia
Withdrawn
Caja de Compensación Familiar CAFAMBogotá, Colombia
Completed
Centro de Diabetes Cardiovascular IPS Ltda.Barranquilla, Colombia
Withdrawn
MHAT Hadzhi DimitarSliven, 8800, Bulgaria
Completed
Salud renalSan Luis, D5702AAx, Argentina
Completed
Hospital Privado de la ComunidadMar del Plata, B7602CBM, Argentina
Withdrawn
Centro de Investigaciones MetabólicasBuenos Aires, C1056ABJ, Argentina
Completed
Centro Médico ViamonteCABA, C1120AAC, Argentina
Completed
Centro de Investigación Médica LanúsLanús, B1824KAJ, Argentina
Completed
Investigación Clínica AplicadaCiudad Autón. de Buenos Aires, C1425AGC, Argentina
Withdrawn
Centro de Investigaciones ClínicasCABA, C1018DES, Argentina
Completed
Shonan Fujisawa Tokushukai HospitalFujisawa, 251-0041, Japan
Completed
Sasebo Chuo HospitalSasebo, 857-1195, Japan
Completed
Hirohata Naika ClinicKitakyushu, 807-0857, Japan
Completed
Naka Kinen ClinicNaka, 311-0113, Japan
Completed
Medical corporation Yamagata Naika ClinicAsahikawa, 078-8234, Japan
Withdrawn
Sekigami ClinicYatsushiro, 866-0824, Japan
Completed
Steel Memorial Yawata HospitalKitakyushu, 805-8508, Japan
Completed
Osaka General Medical CenterOsaka, 558-8558, Japan
Completed
Chang Gung Memorial Hospital KaohsiungKaohsiung, 833, Taiwan
Completed
Far Eastern Memorial HospitalNew Taipei City, 220, Taiwan
Completed
Taipei Veterans General HospitalTaipei, 11217, Taiwan
Completed
Taipei Medical University HospitalTaipei, 110, Taiwan
Completed
Taichung Veterans General HospitalTaichung, 40705, Taiwan
Active, not recruiting
Kemerovo Regional Clinical HospitalKemerovo, 650066, Russian Federation
Completed
PHI "Central Clinical Hospital "RZD-Medicine"Moscow, 129128, Russian Federation
Not yet recruiting
Krasnoyarsk Clinical Hospital n.a. N.S. KarpovichKrasnoyarsk, 660062, Russian Federation
Completed
Voronezh Regional Clinical Consultancy-Diagnostic CenterVoronezh, 394018, Russian Federation
Completed
City Outpatient Clinic #4Voronezh, 394077, Russian Federation
Not yet recruiting
Saratov City Clinical Hospital #9Saratov, 410030, Russian Federation
Completed
First City Clinical Hospital n.a. E.E. VolosevichArkhangelsk, 163001, Russian Federation
Not yet recruiting
City Clinical Hospital #13 Nizhny NovgorodNizhny Novgorod, 603018, Russian Federation
Completed
Novosibirsk State Medical UniversityNovosibirsk, 630091, Russian Federation
Completed
ASL TO5Torino, 10023, Italy
Completed
ASST Bergamo OvestBergamo, 24047, Italy
Completed
Asan Medical CenterSeoul, 05505, Korea, Republic Of
Completed
Kangnam Sacred Heart HospitalSeoul, 07441, Korea, Republic Of
Completed
Holstebro Hospital, Endocrinology dept.Holstebro, DK-7500, Denmark
Withdrawn
Sydvestjysk Sygehus EsbjergEsbjerg, 6700, Denmark
Completed
Steno Diabetes Center CopenhagenGentofte, 2730, Denmark
Completed
Viborg SygehusViborg, 8800, Denmark
Completed
Holbæk SygehusHolbæk, 4300, Denmark
Completed
Aalborg UniversitetshospitalAalborg, 9000, Denmark
Withdrawn
NJ Drum Tower Hospital, the Affil Hos of NJ Univ Med SchoolNanjing, 210008, China
Completed
Huai'an First People's Hospital, Nanjing Medical UniversityHuai'An, 223300, China
Completed
The Second Affiliated Hospital of Nanjing Medical universityNanjing, 210011, China
Completed
APDPLisboa, 1250-189, Portugal
Completed
Hospital Universitario Virgen de las Nieves|Medicina InternaGranada, 18014, Spain
Withdrawn
Fundação Oswaldo Ramos - Hospital do Rim e HipertensãoSao Paulo, 04039-000, Brazil
Withdrawn
Instituto Brasil de Pesquisa Clínica S/A - IBPClinRio de Janeiro, 20241-180, Brazil
Completed
Aarhus Universitetshospital, SkejbyAarhus N, 8200, Denmark
Completed
Queen Mary HospitalHong Kong, Hong Kong
Withdrawn
Fukui-ken Saiseikai HospitalFukui, 918-8503, Japan
Completed
Fukui Prefectural HospitalFukui, 910-8526, Japan
Completed
Fukuoka University Chikushi HospitalChikushino, 818-8502, Japan
Completed
Avdelningen för kliniska prövningar AKPÖrebro, 703 62, Sweden
Completed
Akademiska Sjukhuset NjurmottagningenUppsala, 751 85, Sweden
Completed
Prince of Wales Hospital Hong KongShatin, Hong Kong
Completed
Severance Hospital, Yonsei University Health SystemSeoul, 03722, Korea, Republic Of
Completed
Hospital SAS de Jerez de la FronteraJerez de la Frontera, 11407, Spain

Primary Outcome

  • 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
    date_rangeTime Frame:
    After start of treatment until end of Year 2

Secondary Outcome

  • 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
    date_rangeTime Frame:
    After start of treatment until end of Year 1
  • Progression of non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR)
    date_rangeTime Frame:
    After start of treatment until end of Year 1 and end of Year 2
  • Occurrence of diabetic macular edema (DME)
    date_rangeTime Frame:
    After start of treatment until end of Year 1 and end of Year 2
  • Occurrence of anterior segment neovascularization (ASN)
    date_rangeTime Frame:
    After start of treatment until end of Year 1 and end of Year 2
  • Change in severity of diabetic retinopathy (DR)
    date_rangeTime Frame:
    From strat of treatment to the end of Year 1 and end of Year 2

Trial design

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
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

Click here to find results for studies related to Bayer products