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
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 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
- 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).
Key Trial Info
Start Date :
July 23 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 25 2021
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT04477707
Start Date
July 23 2020
End Date
June 25 2021
Last Update
June 29 2022
Active Locations (62)
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1
California Institute of Renal Research - Chula Vista
Chula Vista, California, United States, 91910
2
California Institute of Renal Research, Inc. - El Centro
El Centro, California, United States, 92243
3
Elixia at Florida Kidney Physicians Southeast
Fort Lauderdale, Florida, United States, 33308
4
John H Stroger Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612