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)
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| ClinicalTrials.gov Identifier: NCT04795726 |
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Recruitment Status :
Completed
First Posted : March 12, 2021
Last Update Posted : July 15, 2021
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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) Drug: Placebo | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 70 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | March 11, 2021 |
| Actual Primary Completion Date : | June 30, 2021 |
| Actual Study Completion Date : | June 30, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment group
Patients received treatment in phase 3 clinical trials FIDELIO-DKD (16244) and FIGARO-DKD (17530).
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Drug: Finerenone (BAY94-8862)
10 mg or 20 mg Finerenone tablet to be given orally, once daily, administered in the FIDELIO-DKD or FIGARO-DKD clinical trial. |
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Placebo Comparator: Placebo group
Patients received placebo in phase 3 clinical trials FIDELIO-DKD (16244) and FIGARO-DKD (17530).
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Drug: Placebo
Matching placebo to be taken orally, once daily, administered in the FIDELIO-DKD or FIGARO-DKD clinical trial. |
- Proportion of participants with 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
- Proportion of participants with 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) 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
- Proportion of participants with progression of NPDR to Proliferative Diabetic Retinopathy (PDR) [ Time Frame: After start of treatment until end of Year 1, and until the end of Year 2 ]
- Proportion of participants with diabetic macular edema (DME) [ Time Frame: After start of treatment until end of Year 1 and end of Year 2 ]
- Proportion of participants with 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 ]
Severity grade of DR:
No DR NPDR (mild or moderate) NPDR (severe) PDR
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04795726
| Bulgaria | |
| Med Centre Diamedical 2013 | |
| Dimitrovgrad, Bulgaria, 6400 | |
| MHAT Sveta Karidad | |
| Plovdiv, Bulgaria, 4004 | |
| MHAT Hadzhi Dimitar | |
| Sliven, Bulgaria, 8800 | |
| MHAT Dr. Bratan Shukerov AD | |
| Smolyan, Bulgaria, 4700 | |
| DCC Aleksandrovska | |
| Sofia, Bulgaria, 1606 | |
| MCOMH Preventsia-2000 | |
| Stara Zagora, Bulgaria, 6000 | |
| MHAT Sveti Pantaleymon | |
| Yambol, Bulgaria, 8600 | |
| United Kingdom | |
| Southmead Hospital | |
| Bristol, Avon, United Kingdom, BS10 5NB | |
| St Richard's Hospital | |
| Chichester, West Sussex, United Kingdom, PO19 6SE | |
| Royal London Hospital | |
| London, United Kingdom, E1 1BB | |
| King's College Hospital - NHS Foundation Trust | |
| London, United Kingdom, SE5 9RS | |
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT04795726 |
| Other Study ID Numbers: |
21618 2020-003865-20 ( EudraCT Number ) |
| First Posted: | March 12, 2021 Key Record Dates |
| Last Update Posted: | July 15, 2021 |
| Last Verified: | July 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Retinal Diseases Diabetic Retinopathy Eye Diseases Diabetic Angiopathies Vascular Diseases |
Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |