Observational study of routine ophthalmological examinations of patients included in the 2 Bayer sponsored phase 3 clinical trials FIDELIO and
A study that uses data from routine eye examinations of patients
Dec. 05, 2020
287376
No
version:
date:
Bayer Yakuhin, Ltd
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byl_ct_contact@bayer.com
Bayer Yakuhin, Ltd
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byl_ct_contact@bayer.com
completed
July. 13, 2020
800
Observational
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Retrospective
treatment purpose
2
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).
20age old over
No limit
Both
Diabetic Retinopathy
investigational material(s)
Generic name etc : finerenone
INN of investigational material : finerenone
Therapeutic category code : 213 Diuretics
Dosage and Administration for Investigational material : Oral, administered in the FIDELIO or FIGARO clinical trial
control material(s)
Generic name etc : placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Oral, administered in the FIDELIO or FIGARO clinical trial
efficacy
Progression of non-proliferative diabetic
retinopathy (NPDR) aftert 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
efficacy
Progression of 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 2 after start of treatment.
Progression of NPDR to PDR after start of treatment until end of Year 1 and end of Year 2.
Occurrence of diabetic macular edema (DME) after start of treatment until end of Year 1 and end of Year 2
Occurrence of anterior segment neovascularization (ASN) after start of treatment until end of Year 1 and end of Year 2
Change in severity of DR From start of treatment to the end of Year 1 and end of Year 2
Bayer Yakuhin, Ltd
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Osaka General Medical Center Institutional Review Board
