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

Bayer Yakuhin, Ltd1 个研究点目标入组 800 人开始时间: 待定最近更新: 2022年8月25日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 800
试验地点: 1
主要终点: Progression of non-proliferative diabetic retinopathy (NPDR)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Observational

入排标准

年龄范围: 20age old over 至 No limit（—）
性别: All

入选标准

•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.

排除标准

•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).

结局指标

主要结局

Progression of non-proliferative diabetic retinopathy (NPDR)

时间窗: after 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)

次要结局

Progression of NPDR(until end of Year 1 and until the end of Year 2 after start of treatment)

研究者

发起方

Bayer Yakuhin, Ltd

研究点 (1)

Loading locations...

相似试验

尚未招募

不适用

A study to measure pressure changes in eye while a person undergoes surgery for spine fracture lying on his back during surgery

CTRI/2019/01/017211Department of Anaesthesiology

尚未招募

不适用

Examination of ophthalmic examination data for infants, school children, and studentsMyopia, hyperopia, astigmatism

JPRN-UMIN000048458iigata University of Health and Welfare2,000

尚未招募

4 期

Tear free test for Piramals Littles organic syndent soap

CTRI/2024/06/068765Piramal Pharma Limited

招募中

Unknown

Tear free test of Piramals Multiple Baby care products.

CTRI/2023/11/059515Piramal Pharma Limited

已完成

不适用

Injecting a substance drop by drop in to Eye to know tear developing ability

CTRI/2020/07/026411Azafran Innovacion ltd25