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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 70
- 试验地点
- 11
- 主要终点
- Proportion of participants with progression of non-proliferative diabetic retinopathy (NPDR)
研究概览
简要总结
Diabetic retinopathy (DR) is a diabetes complication caused by damage to the small blood vessels inside the retina at the back of the eye. Diabetic retinopathy may cause mild vision problems or eventually blindness. Diabetes is a condition that makes your blood sugar levels higher than they should be.
In the early stages of diabetic retinopathy - called non-proliferative diabetic retinopathy (NPDR)- increased blood sugar levels lead to damage to the tiny blood vessels of the retina. This damage results in small outpouchings of the vessel lumens leading to rupture. At the same time the blood vessels can leak and making the retina swell and can cause so called macula edema. In these early stages of DR current treatment to reduce the risk of this eye complication is focused on controlling blood sugar levels and blood pressure.
Participants in this study have NPDR, Type 2 Diabetes (T2D) and Chronic Kidney Disease (CKD), a condition in which the kidneys become damaged and do not work as they should. These participants are already taking part in one of the phase 3 studies (FIDELIO-DKD and FIGARO-DKD). They study the effect of Finerenone on delaying kidney disease progression and reducing the risk of events that may cause damage to the heart and blood vessels To learn more about the effect of Finerenone on diabetic retinopathy, data from routine eye examinations performed during the two phase 3 studies will be collected and analyzed. All male and female participants included in this study are at least 18 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent to participate in DeFineDR
- •Included in FIDELIO-DKD or FIGARO-DKD, 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-DKD or FIGARO-DKD, and up to one month after baseline in FIDELIO-DKD or FIGARO-DKD
- •An ophthalmological assessment available 6 month before or maximum 1 month after the baseline examination in FIDELIO-DKD or FIGARO-DKD, and at least one additional assessment afterwards.
排除标准
- •Participants with PDR, macular edema or anterior segment complications present at baseline in FIDELIO-DKD or FIGARO-DKD in at least one eye.
- •Participants with any documentation of prior or planned retinal laser treatment, intravitreal injection or vitrectomy at baseline in FIDELIO-DKD or FIGARO-DKD in at least one eye.
- •Participants with any other retinal disease documented at baseline in FIDELIO-DKD or FIGARO-DKD in at least one eye that would likely interfere with the study objectives (e.g. neovascular age-related macular degeneration or retinal vein occlusion).
研究组 & 干预措施
Treatment group
Patients received treatment in phase 3 clinical trials FIDELIO-DKD (16244) and FIGARO-DKD (17530).
干预措施: Finerenone (BAY94-8862) (Drug)
Placebo group
Patients received placebo in phase 3 clinical trials FIDELIO-DKD (16244) and FIGARO-DKD (17530).
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of participants with 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) until the end of Year 2 after start of treatment
次要结局
- Proportion of participants with diabetic macular edema (DME)(After start of treatment until end of Year 1 and end of Year 2)
- Proportion of participants with progression of non-proliferative diabetic retinopathy (NPDR)(After start of treatment until end of Year 1)
- Proportion of participants with anterior segment neovascularization (ASN)(After start of treatment until end of Year 1 and end of Year 2)
- Proportion of participants with progression of NPDR to Proliferative Diabetic Retinopathy (PDR)(After start of treatment until end of Year 1, and until the end of Year 2)
- Change in severity of diabetic retinopathy (DR)(From strat of treatment to the end of Year 1 and end of Year 2)