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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) (ReFineDR)

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ClinicalTrials.gov Identifier: NCT04477707
Recruitment Status : Completed
First Posted : July 20, 2020
Last Update Posted : December 22, 2021
Sponsor:
Information provided by (Responsible Party):
Bayer

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
Diabetic Retinopathy Drug: Finerenone (BAY94-8862)

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Study Type : Observational
Actual Enrollment : 206 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational Study of Routine Ophthalmological Examinations of Patients Included in the 2 Bayer Sponsored Phase 3 Clinical Trials FIDELIO and FIGARO to Investigate the Effect of Finerenone on Delaying the Progression of Diabetic Retinopathy
Actual Study Start Date : July 13, 2020
Actual Primary Completion Date : August 26, 2021
Actual Study Completion Date : August 26, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Treatment group
Patients received treatment in phase 3 clinical trials FIDELIO or FIGARO.
Drug: Finerenone (BAY94-8862)
10 mg or 20 mg Finerenone tablet to be given orally, once daily, administered in the FIDELIO or FIGARO clinical trial.

Placebo group
Patients received placebo in phase 3 clinical trials FIDELIO or FIGARO.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Progression of non-proliferative diabetic retinopathy (NPDR) to proliferative diabetic retinopathy (PDR) [ Time Frame: After start of treatment until end of Year 1 and end of Year 2 ]
  3. Occurrence of diabetic macular edema (DME) [ Time Frame: After start of treatment until end of Year 1 and end of Year 2 ]
  4. Occurrence of anterior segment neovascularization (ASN) [ Time Frame: After start of treatment until end of Year 1 and end of Year 2 ]
  5. Change in severity of diabetic retinopathy (DR) [ Time Frame: From strat of treatment to the end of Year 1 and end of Year 2 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cohort of patients included in FIDELIO or FIGARO with NPDR. Patients with at least one routine ophthalmological assessment available at baseline in FIDELIO or FIGARO, and one additional measurement at a later time point.
Criteria

Inclusion Criteria:

  • Signed informed consent to participate in ReFineDR
  • Included in FIDELIO or FIGARO, 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 or FIGARO, and up to one month after baseline in FIDELIO or FIGARO
  • An ophthalmological assessment available 6 month before or maximum 1 month after the baseline examination in FIDELIO or FIGARO, and at least one additional assessment afterwards.

Exclusion Criteria:

  • Patients with PDR, macular edema or anterior segment complications present at baseline in FIDELIO or FIGARO in at least one eye.
  • Patients with any documentation of prior or planned retinal laser treatment, intravitreal injection or vitrectomy at baseline in FIDELIO or FIGARO in at least one eye.
  • Patients with any other retinal disease documented at baseline in FIDELIO or FIGARO in at least one eye that would likely interfere with the study objectives (e.g. neovascular age-related macular degeneration or retinal vein occlusion).

Information from the National Library of Medicine

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): NCT04477707


Locations
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Sponsors and Collaborators
Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04477707    
Other Study ID Numbers: 21311
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: December 22, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases