Diabetic Retinopathy
Conditions
Interventions
investigational material(s)
Generic name etc : finerenone
INN of investigational material : finerenone
Therapeutic category code : 213 Diuretics
Dosage and Administration for Investigational material
Sponsors
Bayer Yakuhin, Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Asia except Japan, Europe, Japan, North America, South America
Outcome results
None listed