ReFineDR: 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)

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT04477707

Collaborator

(none)

206

Enrollment

Locations

11.1

Actual Duration (Months)

3.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy	Drug: Finerenone (BAY94-8862)

Study Design

Study Type:

Observational

Actual Enrollment :

206 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Jul 23, 2020

Actual Primary Completion Date :

Jun 25, 2021

Actual Study Completion Date :

Jun 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Treatment group Patients received treatment in phase 3 clinical trials FIDELIO or FIGARO.	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.
Placebo group Patients received placebo in phase 3 clinical trials FIDELIO or FIGARO.

Arm

Intervention/Treatment

Treatment group

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

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.

Placebo group

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

Outcome Measures

Primary Outcome Measures

Progression of non-proliferative diabetic retinopathy (NPDR) [After start of treatment until end of Year 2]
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

Secondary Outcome Measures

Progression of non-proliferative diabetic retinopathy (NPDR) [After start of treatment until end of Year 1]
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
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Institute of Renal Research - Chula Vista	Chula Vista	California	United States	91910
2	California Institute of Renal Research, Inc. - El Centro	El Centro	California	United States	92243
3	Elixia at Florida Kidney Physicians Southeast	Fort Lauderdale	Florida	United States	33308
4	John H Stroger Jr. Hospital of Cook County	Chicago	Illinois	United States	60612
5	Crescent City Clinical Research Center, LLC	Metairie	Louisiana	United States	70006
6	Joslin Diabetes Center	Boston	Massachusetts	United States	02215
7	Kansas City VA Medical Center	Kansas City	Missouri	United States	64128
8	Office of Osvaldo A. Brusco, MD	Corpus Christi	Texas	United States	78414
9	MedResearch, Inc.	El Paso	Texas	United States	79902-4672
10	Clinical Advancement Center, PLLC	San Antonio	Texas	United States	78212-4740
11	Centro Médico Viamonte	Caba	Buenos Aires	Argentina	C1120AAC
12	Centro de Investigación Médica Lanús	Lanús	Buenos Aires	Argentina	B1824KAJ
13	Hospital Privado de la Comunidad	Mar del Plata	Buenos Aires	Argentina	B7602CBM
14	Investigación Clínica Aplicada	Ciudad Autón. de Buenos Aires	Ciudad Auton. De Buenos Aires	Argentina	C1425AGC
15	Salud renal	San Luis		Argentina	D5702AAx
16	Huai'an First People's Hospital, Nanjing Medical University	Huai'An	Jiangsu	China	223300
17	The Second Affiliated Hospital of Nanjing Medical university	Nanjing	Jiangsu	China	210011
18	Centro de Diabetes Cardiovascular IPS Ltda.	Barranquilla	Atlántico	Colombia	0
19	Aalborg Universitetshospital	Aalborg		Denmark	9000
20	Aarhus Universitetshospital, Skejby	Aarhus N		Denmark	8200
21	Steno Diabetes Center Copenhagen	Gentofte		Denmark	2730
22	Holbæk Sygehus	Holbæk		Denmark	4300
23	Holstebro Hospital, Endocrinology dept.	Holstebro		Denmark	DK-7500
24	Viborg Sygehus	Viborg		Denmark	8800
25	Queen Mary Hospital	Hong Kong		Hong Kong
26	Prince of Wales Hospital Hong Kong	Shatin		Hong Kong
27	Edith Wolfson Medical Center	Holon		Israel	5822012
28	Meir Medical Center	Kfar Saba		Israel	4428164
29	Clalit Health Services, Midgal Hamea	Tel Aviv		Israel	6203854
30	ASST Bergamo Ovest	Bergamo	Lombardia	Italy	24047
31	ASL TO5	Torino	Piemonte	Italy	10023
32	Fukuoka University Chikushi Hospital	Chikushino	Fukuoka	Japan	818-8502
33	Steel Memorial Yawata Hospital	Kitakyushu	Fukuoka	Japan	805-8508
34	Hirohata Naika Clinic	Kitakyushu	Fukuoka	Japan	807-0857
35	Medical corporation Yamagata Naika Clinic	Asahikawa	Hokkaido	Japan	078-8234
36	Naka Kinen Clinic	Naka	Ibaraki	Japan	311-0113
37	Shonan Fujisawa Tokushukai Hospital	Fujisawa	Kanagawa	Japan	251-0041
38	Sasebo Chuo Hospital	Sasebo	Nagasaki	Japan	857-1195
39	Fukui Prefectural Hospital	Fukui		Japan	910-8526
40	Osaka General Medical Center	Osaka		Japan	558-8558
41	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	03722
42	Asan Medical Center	Seoul		Korea, Republic of	05505
43	Kangnam Sacred Heart Hospital	Seoul		Korea, Republic of	07441
44	APDP	Lisboa		Portugal	1250-189
45	First City Clinical Hospital n.a. E.E. Volosevich	Arkhangelsk		Russian Federation	163001
46	Kemerovo Regional Clinical Hospital	Kemerovo		Russian Federation	650066
47	Krasnoyarsk Clinical Hospital n.a. N.S. Karpovich	Krasnoyarsk		Russian Federation	660062
48	PHI "Central Clinical Hospital "RZD-Medicine"	Moscow		Russian Federation	129128
49	City Clinical Hospital #13 Nizhny Novgorod	Nizhny Novgorod		Russian Federation	603018
50	Novosibirsk State Medical University	Novosibirsk		Russian Federation	630091
51	Saratov City Clinical Hospital #9	Saratov		Russian Federation	410030
52	Voronezh Regional Clinical Consultancy-Diagnostic Center	Voronezh		Russian Federation	394018
53	City Outpatient Clinic #4	Voronezh		Russian Federation	394077
54	Hospital SAS de Jerez de la Frontera	Jerez de la Frontera	Cádiz	Spain	11407
55	Hospital Universitario Virgen de las Nieves\|Medicina Interna	Granada		Spain	18014
56	Akademiska Sjukhuset Njurmottagningen	Uppsala		Sweden	751 85
57	Avdelningen för kliniska prövningar AKP	Örebro		Sweden	703 62
58	Chang Gung Memorial Hospital Kaohsiung	Kaohsiung		Taiwan	833
59	Far Eastern Memorial Hospital	New Taipei City		Taiwan	220
60	Taichung Veterans General Hospital	Taichung		Taiwan	40705
61	Taipei Medical University Hospital	Taipei		Taiwan	110
62	Taipei Veterans General Hospital	Taipei		Taiwan	11217

Sponsors and Collaborators

Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Click here to find results for studies related to Bayer products

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT04477707

Other Study ID Numbers:

21311

First Posted:

Jul 20, 2020

Last Update Posted:

Jun 29, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Retinal Diseases

Diabetic Retinopathy

Study Results

No Results Posted as of Jun 29, 2022