Observational study of routine ophthalmological examinations of patients included in the 2 Bayer sponsored phase 3 clinical trials FIDELIO and

Bayer Yakuhin, Ltd0 sites287,376 target enrollmentJuly 10, 2020

Overview

No summary available.

Registry

who.int

Start Date

July 10, 2020

End Date

December 5, 2020

Last Updated

2 years ago

Study Type

Observational

Sex

All

Sponsor

Bayer Yakuhin, Ltd

•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).