Status:
COMPLETED
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)
Lead Sponsor:
Bayer
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
NA
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 eventu...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04795726
Start Date
March 10 2021
End Date
June 30 2021
Last Update
November 2 2022
Active Locations (11)
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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