Using Calcium Dobesilate to Treat Chinese Patients With Mild to Moderate Non-proliferative Diabet… (NCT04283162) | Clinical Trial Compass
UnknownPhase 4
Using Calcium Dobesilate to Treat Chinese Patients With Mild to Moderate Non-proliferative Diabetic Retinopathy
China1,200 participantsStarted 2020-03-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Recei…
What they're measuring
1
The rate of the progression of diabetic retinopathy
Timeframe: from baseline to the end of treatment (12 months later)