NCT04283162

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Zhongda Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	Calcium Dobesilate	use calcium dobesilate at the dosage of 500 mg, orally, 3 times per day, for 12 months
OTHER	conventional treatment	maintain lifestyle habits and the usual treatment

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-12-31
• Completion: 2022-01-31
• First posted: 2020-02-25
• Last updated: 2020-02-25

Locations

1 site across 1 country: China