DeFineDR: 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)

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT04795726
Collaborator
(none)
70
11
2
3.7
6.4
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Finerenone (BAY94-8862)
  • Drug: Placebo
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
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 :
Mar 10, 2021
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group

Patients received treatment in phase 3 clinical trials FIDELIO-DKD (16244) and FIGARO-DKD (17530).

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 Comparator: Placebo group

Patients received placebo in phase 3 clinical trials FIDELIO-DKD (16244) and FIGARO-DKD (17530).

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

Outcome Measures

Primary Outcome Measures

  1. Proportion of participants with progression of non-proliferative diabetic retinopathy (NPDR) [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

Secondary Outcome Measures

  1. Proportion of participants with progression of non-proliferative diabetic retinopathy (NPDR) [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

  2. 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]

  3. Proportion of participants with diabetic macular edema (DME) [After start of treatment until end of Year 1 and end of Year 2]

  4. Proportion of participants with anterior segment neovascularization (ASN) [After start of treatment until end of Year 1 and end of Year 2]

  5. Change in severity of diabetic retinopathy (DR) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Med Centre Diamedical 2013 Dimitrovgrad Bulgaria 6400
2 MHAT Sveta Karidad Plovdiv Bulgaria 4004
3 MHAT Hadzhi Dimitar Sliven Bulgaria 8800
4 MHAT Dr. Bratan Shukerov AD Smolyan Bulgaria 4700
5 DCC Aleksandrovska Sofia Bulgaria 1606
6 MCOMH Preventsia-2000 Stara Zagora Bulgaria 6000
7 MHAT Sveti Pantaleymon - Yambol Yambol Bulgaria 8600
8 Southmead Hospital Bristol Avon United Kingdom BS10 5NB
9 St Richard's Hospital Chichester West Sussex United Kingdom PO19 6SE
10 Royal London Hospital London United Kingdom E1 1BB
11 King's College Hospital - NHS Foundation Trust London United Kingdom SE5 9RS

Sponsors and Collaborators

  • Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT04795726
Other Study ID Numbers:
  • 21618
  • 2020-003865-20
First Posted:
Mar 12, 2021
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 30, 2022