Efficacy of Calcium Dobesilate in Treating Chinese Patients With Mild to Moderate Non-proliferative Diabetic Retinopathy (CALM-DR): a Single-blind, Multicenter, Cluster-randomized, Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- The rate of the progression of diabetic retinopathy
研究概览
简要总结
Calcium dobesilate has been recommended to treat diabetic retinopathy due to its potential in protecting against retinal vascular damage. However, there was limited evidence exploring its efficacy in combating diabetic retinopathy progression. This study, a single-blind, multicenter, cluster-randomized, controlled superiority trial, was designed to evaluate whether calcium dobesilate could prevent diabetic retinopathy progression into an advanced stage among Chinese patients with mild to moderate non-proliferative diabetic retinopathy.
详细描述
A total of 1,200 patients with mild to moderate non-proliferative diabetic retinopathy will be enrolled and randomly assigned at a ratio of 1:1 into the control group (that is, conventional treatment group) and the intervention group (that is, conventional treatment plus calcium dobesilate [500 mg, 3 times per day] for 12 months). The severity of diabetic retinopathy will be assessed by the Early Treatment Diabetic Retinopathy Study scale.
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
- Single (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
- •Being diagnosed with mild to moderate diabetic retinopathy
- •Being older than 18 years
- •Being willing to attend this trial.
排除标准
- •Being allergic hypersensitive to experimental drugs or comparator drugs
- •Having alanine aminotransferase or aspartate aminotransferase ≥2 times higher than the upper limit of normal value, or total bilirubin ≥1.5 times higher than the upper limit of normal value upon the exclusion of mild fatty liver disease
- •Having severe renal insufficiency (defined as an estimated glomerular filtration rate ≤30 mL/min/1.73 m^2)
- •Having malignant tumor and some other life-threatening diseases
- •Being in pregnancy, expecting pregnancy, or breast feeding
- •Being with unstable conditions, such as: uncontrolled high blood pressure (e.g., blood pressure >180/100 mmHg); hemoglobin A1c >8.0% or uncontrolled high blood glucose or hypoglycemia; acute cardiovascular events like unstable angina, congestive heart failure, stroke, transient ischemic attack, or myocardial infarction within the previous 3 months; uncontrolled infection; and diabetic ketoacidosis or hyperosmolar state in the past 1 month
- •Being with glaucoma, cataracts, or other opacities that may interfere with retinal examination and fundus photography
- •Receiving laser treatment, cryo-coagulation, or vitrectomy
- •Taking drugs such as diabetic retinopathy or traditional Chinese medicine that may help to improve micro-vascular function in the past 2 weeks
- •Receiving vascular endothelial growth factor therapy in the past 4 months or will be judged to take vascular endothelial growth factor therapy because of disease progression
- •Having attended other clinical trials in the past 1 month, being attending some clinical trials, or some other conditions that were judged unfit for this trial by investigators
研究组 & 干预措施
conventional treatment plus calcium dobesilate
maintain lifestyle habits and the usual treatment, plus the use of calcium dobesilate (500 mg, orally, 3 times per day) for 12 months
干预措施: Calcium Dobesilate (Drug)
conventional treatment plus calcium dobesilate
maintain lifestyle habits and the usual treatment, plus the use of calcium dobesilate (500 mg, orally, 3 times per day) for 12 months
干预措施: conventional treatment (Other)
conventional treatment group
maintain lifestyle habits and the usual treatment for 12 months
干预措施: conventional treatment (Other)
结局指标
主要结局
The rate of the progression of diabetic retinopathy
时间窗: from baseline to the end of treatment (12 months later)
Diabetic retinopathy progression is defined as an increase of 2 or more steps on the Early Treatment Diabetic Retinopathy Study scale during follow-up.
次要结局
- Changes in the retinal blood vessel diameter and arteriovenous ratio(3-month, 6-month, and 12-month from baseline)
- Changes in metabolic biomarkers such as HbA1c(3-month, 6-month, and 12-month from baseline)
- Changes in eyesight(3-month, 6-month, and 12-month from baseline)
- Changes in the numbers, location, and types of the retinal lesions(3-month, 6-month, and 12-month from baseline)
研究者
Zilin Sun
Chief Physician, Professor of Medicine
Zhongda Hospital