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

Primary Purpose

Diabetic Retinopathy

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Calcium Dobesilate

conventional treatment

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring calcium dobesilate, mild to moderate non-proliferative diabetic retinopathy, cluster-randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

conventional treatment plus calcium dobesilate

conventional treatment group

Arm Description

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

maintain lifestyle habits and the usual treatment for 12 months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in eyesight

Changes in eyesight assessed by visual chart at 4 m by optometrists

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

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

Changes in metabolic biomarkers such as HbA1c

The metabolic biomarkers were assessed by laboratory measurement at different time-points

Full Information

NCT ID

NCT04283162

First Posted

February 16, 2020

Last Updated

February 23, 2020

Sponsor

Zhongda Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04283162

Brief Title

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

Acronym

CALM-DR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2020 (Anticipated)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhongda Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Retinopathy

Keywords

calcium dobesilate, mild to moderate non-proliferative diabetic retinopathy, cluster-randomized controlled trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

conventional treatment plus calcium dobesilate

Arm Type

Experimental

Arm Description

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

Arm Title

conventional treatment group

Arm Type

Active Comparator

Arm Description

maintain lifestyle habits and the usual treatment for 12 months

Intervention Type

Drug

Intervention Name(s)

Calcium Dobesilate

Other Intervention Name(s)

calcium dobesilate use

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

conventional treatment

Other Intervention Name(s)

usual care

Intervention Description

maintain lifestyle habits and the usual treatment

Primary Outcome Measure Information:

Title

The rate of the progression of diabetic retinopathy

Description

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)

Secondary Outcome Measure Information:

Title

Changes in eyesight

Description

Changes in eyesight assessed by visual chart at 4 m by optometrists

Time Frame

3-month, 6-month, and 12-month from baseline

Title

Changes in the numbers, location, and types of the retinal lesions

Description

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

Title

Changes in the retinal blood vessel diameter and arteriovenous ratio

Description

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

Title

Changes in metabolic biomarkers such as HbA1c

Description

The metabolic biomarkers were assessed by laboratory measurement at different time-points

Time Frame

3-month, 6-month, and 12-month from baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zilin Sun, Ph.D.

Phone

008602583262813

sunzilin1963@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zilin Sun, Ph.D.

Organizational Affiliation

Zhongda Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Nanjing

State/Province

Jiangsu

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

34049911

Citation

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.

Results Reference

derived

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

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