Clinical trial NCT04795726: 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Retinopathy
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2021-03-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Proportion of participants with progression of non-proliferative diabetic retinopathy (NPDR)
timeFrame: After start of treatment until end of Year 2
Secondary outcomes:
measure: Proportion of participants with progression of non-proliferative diabetic retinopathy (NPDR)
timeFrame: After start of treatment until end of Year 1
measure: Proportion of participants with progression of NPDR to Proliferative Diabetic Retinopathy (PDR)
timeFrame: After start of treatment until end of Year 1, and until the end of Year 2
measure: Proportion of participants with diabetic macular edema (DME)
timeFrame: After start of treatment until end of Year 1 and end of Year 2
measure: Proportion of participants with anterior segment neovascularization (ASN)
timeFrame: After start of treatment until end of Year 1 and end of Year 2
measure: Change in severity of diabetic retinopathy (DR)
timeFrame: From strat of treatment to the end of Year 1 and end of Year 2
Other outcomes:
Locations:
city: Dimitrovgrad
country: Bulgaria
facility: Med Centre Diamedical 2013
city: Plovdiv
country: Bulgaria
facility: MHAT Sveta Karidad
city: Sliven
country: Bulgaria
facility: MHAT Hadzhi Dimitar
city: Smolyan
country: Bulgaria
facility: MHAT Dr. Bratan Shukerov AD
city: Sofia
country: Bulgaria
facility: DCC Aleksandrovska
city: Stara Zagora
country: Bulgaria
facility: MCOMH Preventsia-2000
city: Yambol
country: Bulgaria
facility: MHAT Sveti Pantaleymon - Yambol
city: Bristol
country: United Kingdom
facility: Southmead Hospital
state: Avon
city: Chichester
country: United Kingdom
facility: St Richard's Hospital
state: West Sussex
city: London
country: United Kingdom
facility: Royal London Hospital
city: London
country: United Kingdom
facility: King's College Hospital - NHS Foundation Trust
Study officials:
References: