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)
DeFineDR
A Clinical Trial Collecting Data From Routine Ophthalmological Examinations of Patients Who Were Randomized to Either Finerenone or Placebo in the Two Bayer-sponsored Phase 3 Clinical Trials FIDELIO-DKD and FIGARO-DKD to Investigate the Effect of Finerenone on Delaying the Progression of Diabetic Retinopathy
2 other identifiers
interventional
70
2 countries
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2021
Shorter than P25 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2021
CompletedStudy Start
First participant enrolled
March 10, 2021
CompletedFirst Posted
Study publicly available on registry
March 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedNovember 2, 2022
October 1, 2022
4 months
February 26, 2021
October 31, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of participants with 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 Outcomes (5)
Proportion of participants with progression of non-proliferative diabetic retinopathy (NPDR)
After start of treatment until end of Year 1
Proportion of participants with progression of NPDR to Proliferative Diabetic Retinopathy (PDR)
After start of treatment until end of Year 1, and until the end of Year 2
Proportion of participants with diabetic macular edema (DME)
After start of treatment until end of Year 1 and end of Year 2
Proportion of participants with 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
Study Arms (2)
Treatment group
EXPERIMENTALPatients received treatment in phase 3 clinical trials FIDELIO-DKD (16244) and FIGARO-DKD (17530).
Placebo group
PLACEBO COMPARATORPatients received placebo in phase 3 clinical trials FIDELIO-DKD (16244) and FIGARO-DKD (17530).
Interventions
10 mg or 20 mg Finerenone tablet to be given orally, once daily, administered in the FIDELIO-DKD or FIGARO-DKD clinical trial.
Matching placebo to be taken orally, once daily, administered in the FIDELIO-DKD or FIGARO-DKD clinical trial.
Eligibility Criteria
You may qualify if:
- Signed informed consent to participate in DeFineDR
- Included in FIDELIO-DKD or FIGARO-DKD, 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-DKD or FIGARO-DKD, and up to one month after baseline in FIDELIO-DKD or FIGARO-DKD
- An ophthalmological assessment available 6 month before or maximum 1 month after the baseline examination in FIDELIO-DKD or FIGARO-DKD, and at least one additional assessment afterwards.
You may not qualify if:
- Participants with PDR, macular edema or anterior segment complications present at baseline in FIDELIO-DKD or FIGARO-DKD in at least one eye.
- Participants with any documentation of prior or planned retinal laser treatment, intravitreal injection or vitrectomy at baseline in FIDELIO-DKD or FIGARO-DKD in at least one eye.
- Participants with any other retinal disease documented at baseline in FIDELIO-DKD or FIGARO-DKD in at least one eye that would likely interfere with the study objectives (e.g. neovascular age-related macular degeneration or retinal vein occlusion).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (11)
Med Centre Diamedical 2013
Dimitrovgrad, 6400, Bulgaria
MHAT Sveta Karidad
Plovdiv, 4004, Bulgaria
MHAT Hadzhi Dimitar
Sliven, 8800, Bulgaria
MHAT Dr. Bratan Shukerov AD
Smolyan, 4700, Bulgaria
DCC Aleksandrovska
Sofia, 1431, Bulgaria
MCOMH Preventsia-2000
Stara Zagora, 6000, Bulgaria
MHAT Sveti Pantaleymon - Yambol
Yambol, 8600, Bulgaria
Southmead Hospital
Bristol, Avon, BS10 5NB, United Kingdom
St Richard's Hospital
Chichester, West Sussex, PO19 6SE, United Kingdom
Royal London Hospital
London, E1 1BB, United Kingdom
King's College Hospital - NHS Foundation Trust
London, SE5 9RS, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2021
First Posted
March 12, 2021
Study Start
March 10, 2021
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
November 2, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later 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.vivli.org 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 member section of the portal.