Effects of Candesartan Cilexetil (Candesartan) on Diabetic Retinopathy in Type 2 Diabetic Patients With Retinopathy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 4,717
- 主要终点
- Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale
研究概览
简要总结
The primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normoalbuminuric type 2 diabetic patients with retinopathy.
The secondary objective is to determine whether candesartan, compared to placebo, reduces the incidence of clinically significant macular oedema (CSME) and/or proliferative diabetic retinopathy (PDR) and beneficially influences the rate change in urinary albumin excretion rate (UAER).
This study is part of the DIRECT Programme also including a primary prevention study of diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 1 diabetes. The primary objective for all three pooled studies is to determine whether candesartan, compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 37 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 37 - 75 years with type 2 diabetes diagnosed at age of 36 years or thereafter.
- •Duration of diabetes for > 1 year and < 20 years with stable diabetic therapy within last 6 months.
- •Patients with untreated resting mean sitting SBP < 130 mmHg and mean sitting DBP < 85 or treated resting mean SBP < 160 mmHg and mean sitting DBP < 90 mmHg with retinal photograph grading level >20/10 up to < 47/47 (on ETDRS severity scale).
排除标准
- •Patients with the following conditions are excluded from participation in the study:
- •Cataract or media opacity of a degree which precludes taking gradable retinal photographs
- •Angle closure glaucoma, which precludes pharmacological dilatation of the pupil
- •History of or presence of proliferative retinopathy
- •History or presence of clinical significant macular oedema (CSME)
- •History or evidence of photocoagulation of the retina
- •Other retinal conditions which may mask assessment, eg, retinal vein occlusion
- •Positive micral dipstick test
- •Presence of secondary diabetes
- •Pregnant or lactating women or women of child bearing potential not practicing an adequate method of contraception
- •Need of treatment with ACE-inhibitor
- •Haemodynamically significant aortic or mitral valve stenosis
- •Known renal artery stenosis or kidney transplantation
- •Hypersensitivity to study drug
- •Severe concomitant disease which may interfere with the assessment of the patient, eg, malignancy, as judged by the investigator
研究组 & 干预措施
candesartan
candesartan cilexetil 32 mg once daily
干预措施: candesartan (Drug)
结局指标
主要结局
Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale
时间窗: From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.
3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized log-rank test was used to test difference between treatments.
次要结局
- Number of Participants With at Least a 3 Step Improvement or a Persistent 2-step Improvement in the ETDRS Severity Scale.(From baseline to end of study, i.e. 5 years.)
- Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR).(From baseline to end of study, i.e. 5 years.)
- Rate of Change in Urinary Albumin Excretion Rate (UAER).(From Baseline to end of study, i.e. 5 years.)