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

Bayer Yakuhin, Ltd0 个研究点目标入组 287,376 人开始时间: 2020年7月10日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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).

发起方

Bayer Yakuhin, Ltd