Using Calcium Dobesilate to Treat Chinese Patients With Mild to Moderate Non-proliferative Diabetic Retinopathy

Launched by ZHONGDA HOSPITAL · Feb 23, 2020

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Being diagnosed with mild to moderate diabetic retinopathy
• • Being older than 18 years
• • Being willing to attend this trial.
• Exclusion Criteria:
• • 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