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)

Diabetic Retinopathy Clinical Trial

— DeFineDR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04795726
• Other study ID #: 21618
• Secondary ID: 2020-003865-20
• Status: Completed
• Phase: N/A
• Start date: March 10, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

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

Locations

Country	Name	City	State
Bulgaria	Med Centre Diamedical 2013	Dimitrovgrad
Bulgaria	MHAT Sveta Karidad	Plovdiv
Bulgaria	MHAT Hadzhi Dimitar	Sliven
Bulgaria	MHAT Dr. Bratan Shukerov AD	Smolyan
Bulgaria	DCC Aleksandrovska	Sofia
Bulgaria	MCOMH Preventsia-2000	Stara Zagora
Bulgaria	MHAT Sveti Pantaleymon - Yambol	Yambol
United Kingdom	Southmead Hospital	Bristol	Avon
United Kingdom	St Richard's Hospital	Chichester	West Sussex
United Kingdom	King's College Hospital - NHS Foundation Trust	London
United Kingdom	Royal London Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Bulgaria,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	After start of treatment until end of Year 1
Secondary	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
Secondary	Proportion of participants with diabetic macular edema (DME)		After start of treatment until end of Year 1 and end of Year 2
Secondary	Proportion of participants with anterior segment neovascularization (ASN)		After start of treatment until end of Year 1 and end of Year 2
Secondary	Change in severity of diabetic retinopathy (DR)	Severity grade of DR: No DR NPDR (mild or moderate) NPDR (severe) PDR	From strat of treatment to the end of Year 1 and end of Year 2

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