check_circleStudy Completed

Diabetic Retinopathy

Bayer Identifier:

21618

ClinicalTrials.gov Identifier:

NCT04795726

EudraCT Number:

2020-003865-20

EU CT Number:

Not Available
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)

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.
  • - 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 summary

Enrollment Goal
70
Trial Dates
March 2021 - June 2021
Phase
N/A
Could I Receive a placebo
Yes
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
MCOMH Preventsia-2000Stara Zagora, 6000, Bulgaria
Completed
Med Centre Diamedical 2013Dimitrovgrad, 6400, Bulgaria
Completed
MHAT Dr. Bratan Shukerov ADSmolyan, 4700, Bulgaria
Completed
MHAT Sveta KaridadPlovdiv, 4004, Bulgaria
Completed
MHAT Hadzhi DimitarSliven, 8800, Bulgaria
Completed
DCC AleksandrovskaSofia, 1431, Bulgaria
Completed
MHAT Sveti Pantaleymon - YambolYambol, 8600, Bulgaria
Completed
Royal London HospitalLondon, E1 1BB, United Kingdom
Completed
Southmead HospitalBristol, BS10 5NB, United Kingdom
Completed
King's College Hospital - NHS Foundation TrustLondon, SE5 9RS, United Kingdom
Completed
St Richard's HospitalChichester, PO19 6SE, United Kingdom

Primary Outcome

  • 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
    date_rangeTime Frame:
    After start of treatment until end of Year 2

Secondary Outcome

  • 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
    date_rangeTime Frame:
    After start of treatment until end of Year 1
  • Proportion of participants with progression of NPDR to Proliferative Diabetic Retinopathy (PDR)
    date_rangeTime 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)
    date_rangeTime Frame:
    After start of treatment until end of Year 1 and end of Year 2
  • Proportion of participants with anterior segment neovascularization (ASN)
    date_rangeTime Frame:
    After start of treatment until end of Year 1 and end of Year 2
  • Change in severity of diabetic retinopathy (DR)
    Severity grade of DR: No DR NPDR (mild or moderate) NPDR (severe) PDR
    date_rangeTime Frame:
    From strat of treatment to the end of Year 1 and end of Year 2

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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