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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,200
use calcium dobesilate at the dosage of 500 mg, orally, 3 times per day, for 12 months
maintain lifestyle habits and the usual treatment
Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, Southeast University
Nanjing, Jiangsu, China
The rate of the progression of diabetic retinopathy
Diabetic retinopathy progression is defined as an increase of 2 or more steps on the Early Treatment Diabetic Retinopathy Study scale during follow-up.
Time frame: from baseline to the end of treatment (12 months later)
Changes in eyesight
Changes in eyesight assessed by visual chart at 4 m by optometrists
Time frame: 3-month, 6-month, and 12-month from baseline
Changes in the numbers, location, and types of the retinal lesions
Using retinal photography to detect the changes in the numbers, location, and types of the retinal lesions at different time-points
Time frame: 3-month, 6-month, and 12-month from baseline
Changes in the retinal blood vessel diameter and arteriovenous ratio
Using photography (optic disc-centered photograph) to detect the retinal blood vessel diameter and arteriovenous ratio at different time-points
Time frame: 3-month, 6-month, and 12-month from baseline
Changes in metabolic biomarkers such as HbA1c
The metabolic biomarkers were assessed by laboratory measurement at different time-points
Time frame: 3-month, 6-month, and 12-month from baseline
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