A clinical trial collecting Data from routine ophthalmological examinations of patients who were randomized to either finerenone or placebo in the two Bayer-sponsored Phase 3 clinical trials FIDELIO-DKD and FIGARO-DKD to investigate the effect of Finerenone on delaying the progression of Diabetic Retinopathy - DeFineDR

Bayer AG0 个研究点目标入组 90 人开始时间: 2021年1月4日最近更新: 2022年5月16日

适应症

试验速览

暂无简介。

•1. Signed informed consent to participate in this study
•2. Included in FIDELIO (2015-000990-11) or FIGARO (2015-000950-39), and with Diabetic Retinopathy as medical history
•3. Documented Non Proliferative Diabetic Retinopathy 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
•4. 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 34
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 56

•1. Patients with Proliferative Diabetic Retinopathy, macular edema or anterior segment complications present at baseline in FIDELIO or FIGARO in at least one eye.
•2. 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.
•3. 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).

发起方