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

NCT ID: NCT04283162

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2022-01-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

conventional treatment plus calcium dobesilate

maintain lifestyle habits and the usual treatment, plus the use of calcium dobesilate (500 mg, orally, 3 times per day) for 12 months

Group Type: EXPERIMENTAL

Calcium Dobesilate

Intervention Type: DRUG

use calcium dobesilate at the dosage of 500 mg, orally, 3 times per day, for 12 months

conventional treatment

Intervention Type: OTHER

maintain lifestyle habits and the usual treatment

conventional treatment group

maintain lifestyle habits and the usual treatment for 12 months

Group Type: ACTIVE_COMPARATOR

conventional treatment

Intervention Type: OTHER

maintain lifestyle habits and the usual treatment

Interventions

Calcium Dobesilate

use calcium dobesilate at the dosage of 500 mg, orally, 3 times per day, for 12 months

Intervention Type: DRUG

conventional treatment

maintain lifestyle habits and the usual treatment

Intervention Type: OTHER

Other Intervention Names

calcium dobesilate use; usual care

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongda Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zilin Sun

Chief Physician, Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zilin Sun, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Zhongda Hospital

Locations

Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, Southeast University

Nanjing, Jiangsu, China

Countries

China

Central Contacts

Zilin Sun, Ph.D.

Role: CONTACT

sunzilin1963@126.com

008602583262813

References

Hu H, Liu J, Wang D, Qiu S, Yuan Y, Wang F, Wen L, Song Q, Sun ZL. Efficacy of calcium dobesilate in treating Chinese patients with mild-to-moderate non-proliferative diabetic retinopathy (CALM-DR): protocol for a single-blind, multicentre, 24-armed cluster-randomised, controlled trial. BMJ Open. 2021 May 28;11(5):e045256. doi: 10.1136/bmjopen-2020-045256.

Reference Type: DERIVED

PMID: 34049911 (View on PubMed)

Other Identifiers

ZhongdaH-February

Identifier Type: -

Identifier Source: org_study_id