Diabetic RetinopathyReFineDRNCT04477707
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)
An observational study of Diabetic Retinopathy, run by Bayer at 62 sites in 15 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Finerenone (BAY94-8862)
- Type of treatment
- Pill or oral medicine
- How many people
- 206 participants
- Where
- 62 sitesin 15 countries
- Study dates
- 23 Jul 2020to 25 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
62 sites in 15 countries.
62 sites in 15 countries
United States10 sites
Joslin Diabetes Center
Boston, Massachusetts, 02215
John H Stroger Jr. Hospital of Cook County
Chicago, Illinois, 60612
California Institute of Renal Research - Chula Vista
Chula Vista, California, 91910
Office of Osvaldo A. Brusco, MD
Corpus Christi, Texas, 78414
California Institute of Renal Research, Inc. - El Centro
El Centro, California, 92243
MedResearch, Inc.
El Paso, Texas, 79902-4672
Elixia at Florida Kidney Physicians Southeast
Fort Lauderdale, Florida, 33308
Kansas City VA Medical Center
Kansas City, Missouri, 64128
Crescent City Clinical Research Center, LLC
Metairie, Louisiana, 70006
Clinical Advancement Center, PLLC
San Antonio, Texas, 78212-4740
Japan9 sites
Medical corporation Yamagata Naika Clinic
Asahikawa, Hokkaido, 078-8234
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, 818-8502
Shonan Fujisawa Tokushukai Hospital
Fujisawa, Kanagawa, 251-0041
Fukui Prefectural Hospital
Fukui, 910-8526
Steel Memorial Yawata Hospital
Kitakyushu, Fukuoka, 805-8508
Hirohata Naika Clinic
Kitakyushu, Fukuoka, 807-0857
Naka Kinen Clinic
Naka, Ibaraki, 311-0113
Osaka General Medical Center
Osaka, 558-8558
Sasebo Chuo Hospital
Sasebo, Nagasaki, 857-1195
Russia9 sites
First City Clinical Hospital n.a. E.E. Volosevich
Arkhangelsk, 163001
Kemerovo Regional Clinical Hospital
Kemerovo, 650066
Krasnoyarsk Clinical Hospital n.a. N.S. Karpovich
Krasnoyarsk, 660062
PHI "Central Clinical Hospital "RZD-Medicine"
Moscow, 129128
City Clinical Hospital #13 Nizhny Novgorod
Nizhny Novgorod, 603018
Novosibirsk State Medical University
Novosibirsk, 630091
Saratov City Clinical Hospital #9
Saratov, 410030
Voronezh Regional Clinical Consultancy-Diagnostic Center
Voronezh, 394018
City Outpatient Clinic #4
Voronezh, 394077
Denmark6 sites
Aalborg Universitetshospital
Aalborg, 9000
Aarhus Universitetshospital, Skejby
Aarhus N, 8200
Steno Diabetes Center Copenhagen
Gentofte Municipality, 2730
Holbæk Sygehus
Holbæk, 4300
Holstebro Hospital, Endocrinology dept.
Holstebro, DK-7500
Viborg Sygehus
Viborg, 8800
Argentina5 sites
Centro Médico Viamonte
CABA, Buenos Aires, C1120AAC
Investigación Clínica Aplicada
Ciudad Autón. de Buenos Aires, Ciudad Auton. de Buenos Aires, C1425AGC
Centro de Investigación Médica Lanús
Lanus, Buenos Aires, B1824KAJ
Hospital Privado de la Comunidad
Mar del Plata, Buenos Aires, B7602CBM
Salud renal
San Luis, D5702AAx
Taiwan5 sites
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung City, 833
Far Eastern Memorial Hospital
New Taipei City, 220
Taichung Veterans General Hospital
Taichung, 40705
Taipei Medical University Hospital
Taipei, 110
Taipei Veterans General Hospital
Taipei, 11217
Israel3 sites
Edith Wolfson Medical Center
Holon, 5822012
Meir Medical Center
Kfar Saba, 4428164
Clalit Health Services, Midgal Hamea
Tel Aviv, 6203854
South Korea3 sites
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Kangnam Sacred Heart Hospital
Seoul, 07441
China2 sites
Huai'an First People's Hospital, Nanjing Medical University
Huai'an, Jiangsu, 223300
The Second Affiliated Hospital of Nanjing Medical university
Nanjing, Jiangsu, 210011
Hong Kong2 sites
Queen Mary Hospital
Hong Kong
Prince of Wales Hospital Hong Kong
Shatin
Italy2 sites
ASST Bergamo Ovest
Bergamo, Lombardy, 24047
ASL TO5
Turin, Piedmont, 10023
Spain2 sites
Hospital Universitario Virgen de las Nieves|Medicina Interna
Granada, 18014
Hospital SAS de Jerez de la Frontera
Jerez de la Frontera, Cádiz, 11407
Sweden2 sites
Avdelningen för kliniska prövningar AKP
Örebro, 703 62
Akademiska Sjukhuset Njurmottagningen
Uppsala, 751 85
Colombia1 site
Centro de Diabetes Cardiovascular IPS Ltda.
Barranquilla, Atlántico, 0
About this study
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
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
- Being tested
- Finerenone (BAY94-8862)
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Patients received treatment in phase 3 clinical trials FIDELIO or FIGARO. Receives: Drug: Finerenone (BAY94-8862) | |
| Placebo group | Patients received placebo in phase 3 clinical trials FIDELIO or FIGARO. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After start of treatment until end of Year 2
Secondary outcomes (5)
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
Measured: After start of treatment until end of Year 1
Progression of non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR)
Measured: After start of treatment until end of Year 1 and end of Year 2
Occurrence of diabetic macular edema (DME)
Measured: After start of treatment until end of Year 1 and end of Year 2
Occurrence of anterior segment neovascularization (ASN)
Measured: After start of treatment until end of Year 1 and end of Year 2
Change in severity of diabetic retinopathy (DR)
Measured: From strat of treatment to the end of Year 1 and end of Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start23 Jul 2020
- Primary completion25 Jun 2021
- Study completion25 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477707
- Sponsor's protocol ID
- 21311
- Acronym
- ReFineDR
- Status last verified
- Jun 2022
- First submitted
- 16 Jul 2020
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04477707
- Acronym / sponsor ID
- ReFineDR / 21311
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Drug: Finerenone (BAY94-8862)Patients received treatment in phase 3 clinical trials FIDELIO or FIGARO. |
| Placebo group | – | –Patients received placebo in phase 3 clinical trials FIDELIO or FIGARO. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finerenone (BAY94-8862)10 mg or 20 mg Finerenone tablet to be given orally, once daily, administered in the FIDELIO or FIGARO clinical trial. | Drug | Treatment group |
Primary outcome
Progression of non-proliferative diabetic retinopathy (NPDR)
Time frame: 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
5 secondary outcomes
Progression of non-proliferative diabetic retinopathy (NPDR)
Time frame: After start of treatment until end of Year 1
Progression of non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR)
Time frame: After start of treatment until end of Year 1 and end of Year 2
Occurrence of diabetic macular edema (DME)
Time frame: After start of treatment until end of Year 1 and end of Year 2
Occurrence of anterior segment neovascularization (ASN)
Time frame: After start of treatment until end of Year 1 and end of Year 2
Change in severity of diabetic retinopathy (DR)
Time frame: From strat of treatment to the end of Year 1 and end of Year 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
62 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by Bayer at 62 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States, Japan, Russia, Denmark, Argentina and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of non-proliferative diabetic retinopathy (NPDR) (time frame: After start of treatment until end of Year 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022.