Status:
UNKNOWN
Using Calcium Dobesilate to Treat Chinese Patients With Mild to Moderate Non-proliferative Diabetic Retinopathy
Lead Sponsor:
Zhongda Hospital
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Being diagnosed with mild to moderate diabetic retinopathy
- Being older than 18 years
- Being willing to attend this trial.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2022
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT04283162
Start Date
March 1 2020
End Date
January 31 2022
Last Update
February 25 2020
Active Locations (1)
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1
Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, Southeast University
Nanjing, Jiangsu, China