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AzTrials

Diabetic RetinopathyDeFineDRNCT04795726

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)

A study testing Finerenone (BAY94-8862) in people with Diabetic Retinopathy, run by Bayer at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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?
Ages 18 years and older
Conditions the study is for
Diabetic Retinopathy
What is being tested?
Finerenone (BAY94-8862)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
11 sitesin 2 countries
Study dates
10 Mar 2021to 30 Jun 2021
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

Bulgaria7 sites

  • Med Centre Diamedical 2013

    Dimitrovgrad, 6400

  • MHAT Sveta Karidad

    Plovdiv, 4004

  • MHAT Hadzhi Dimitar

    Sliven, 8800

  • MHAT Dr. Bratan Shukerov AD

    Smolyan, 4700

  • DCC Aleksandrovska

    Sofia, 1431

  • MCOMH Preventsia-2000

    Stara Zagora, 6000

  • MHAT Sveti Pantaleymon - Yambol

    Yambol, 8600

Other trials in Bulgaria

United Kingdom4 sites

  • Southmead Hospital

    Bristol, Avon, BS10 5NB

  • St Richard's Hospital

    Chichester, West Sussex, PO19 6SE

  • Royal London Hospital

    London, E1 1BB

  • King's College Hospital - NHS Foundation Trust

    London, SE5 9RS

Other trials in United Kingdom

About this study

Official title: 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

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.

Being tested
Finerenone (BAY94-8862), Placebo
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-DKD or FIGARO-DKD clinical trial.

  • PlaceboDrug

    Matching placebo to be taken orally, once daily, administered in the FIDELIO-DKD or FIGARO-DKD clinical trial.

Study groups in NCT04795726
Study groupRoleWhat they receive
Treatment groupExperimentalPatients received treatment in phase 3 clinical trials FIDELIO-DKD (16244) and FIGARO-DKD (17530).
Receives: Drug: Finerenone (BAY94-8862)
Placebo groupPlacebo comparatorPatients received placebo in phase 3 clinical trials FIDELIO-DKD (16244) and FIGARO-DKD (17530).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: After start of treatment until end of Year 2

Secondary outcomes (5)

  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 1 after start of treatment

    Measured: After start of treatment until end of Year 1

  2. Proportion of participants with progression of NPDR to Proliferative Diabetic Retinopathy (PDR)

    Measured: After start of treatment until end of Year 1, and until the end of Year 2

  3. Proportion of participants with diabetic macular edema (DME)

    Measured: After start of treatment until end of Year 1 and end of Year 2

  4. Proportion of participants with anterior segment neovascularization (ASN)

    Measured: After start of treatment until end of Year 1 and end of Year 2

  5. Change in severity of diabetic retinopathy (DR)

    Severity grade of DR:

    No DR NPDR (mild or moderate) NPDR (severe) PDR

    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.

  1. First posted12 Mar 2021
  2. Study start10 Mar 2021
  3. Primary completion30 Jun 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04795726
Sponsor's protocol ID
21618
Other IDs
2020-003865-20
Acronym
DeFineDR
Status last verified
Oct 2022
First submitted
26 Feb 2021
Last updated
2 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Finerenone (BAY94-8862) in people with Diabetic Retinopathy, run by Bayer at 11 sites in 2 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 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Bulgaria, United Kingdom. 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. Some participants in this study may receive a placebo. 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?

Proportion of participants with 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?

On the ClinicalTrials.gov record for NCT04795726.

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 2 Nov 2022.

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