Using Calcium Dobesilate to Treat Chinese Patients With Mild to Moderate Non-proliferative Diabetic Retinopathy (CALM-DR)

February 23, 2020 updated by: Zilin Sun, Zhongda Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, Southeast University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Calcium Dobesilate
use calcium dobesilate at the dosage of 500 mg, orally, 3 times per day, for 12 months
Other Names:
  • calcium dobesilate use
Other: conventional treatment
maintain lifestyle habits and the usual treatment
Other Names:
  • usual care
Active Comparator: conventional treatment group
maintain lifestyle habits and the usual treatment for 12 months
Other: conventional treatment
maintain lifestyle habits and the usual treatment
Other Names:
  • usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of the progression of diabetic retinopathy
Time Frame: from baseline to the end of treatment (12 months later)
Diabetic retinopathy progression is defined as an increase of 2 or more steps on the Early Treatment Diabetic Retinopathy Study scale during follow-up.
from baseline to the end of treatment (12 months later)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in eyesight
Time Frame: 3-month, 6-month, and 12-month from baseline
Changes in eyesight assessed by visual chart at 4 m by optometrists
3-month, 6-month, and 12-month from baseline
Changes in the numbers, location, and types of the retinal lesions
Time Frame: 3-month, 6-month, and 12-month from baseline
Using retinal photography to detect the changes in the numbers, location, and types of the retinal lesions at different time-points
3-month, 6-month, and 12-month from baseline
Changes in the retinal blood vessel diameter and arteriovenous ratio
Time Frame: 3-month, 6-month, and 12-month from baseline
Using photography (optic disc-centered photograph) to detect the retinal blood vessel diameter and arteriovenous ratio at different time-points
3-month, 6-month, and 12-month from baseline
Changes in metabolic biomarkers such as HbA1c
Time Frame: 3-month, 6-month, and 12-month from baseline
The metabolic biomarkers were assessed by laboratory measurement at different time-points
3-month, 6-month, and 12-month from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongda Hospital

Investigators

  • Principal Investigator: Zilin Sun, Ph.D., Zhongda Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

January 31, 2022

Study Registration Dates

First Submitted

February 16, 2020

First Submitted That Met QC Criteria

February 23, 2020

First Posted (Actual)

February 25, 2020

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 23, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZhongdaH-February

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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