Using Calcium Dobesilate to Treat Chinese Patients With Mild to Moderate Non-proliferative Diabetic Retinopathy
CALM-DR
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
1 other identifier
interventional
1,200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2020
CompletedFirst Posted
Study publicly available on registry
February 25, 2020
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedFebruary 25, 2020
February 1, 2020
1.8 years
February 16, 2020
February 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
from baseline to the end of treatment (12 months later)
Secondary Outcomes (4)
Changes in eyesight
3-month, 6-month, and 12-month from baseline
Changes in the numbers, location, and types of the retinal lesions
3-month, 6-month, and 12-month from baseline
Changes in the retinal blood vessel diameter and arteriovenous ratio
3-month, 6-month, and 12-month from baseline
Changes in metabolic biomarkers such as HbA1c
3-month, 6-month, and 12-month from baseline
Study Arms (2)
conventional treatment plus calcium dobesilate
EXPERIMENTALmaintain lifestyle habits and the usual treatment, plus the use of calcium dobesilate (500 mg, orally, 3 times per day) for 12 months
conventional treatment group
ACTIVE COMPARATORmaintain lifestyle habits and the usual treatment for 12 months
Interventions
use calcium dobesilate at the dosage of 500 mg, orally, 3 times per day, for 12 months
maintain lifestyle habits and the usual treatment
Eligibility Criteria
You may qualify if:
- Being diagnosed with mild to moderate diabetic retinopathy
- Being older than 18 years
- Being willing to attend this trial.
You may not qualify if:
- Being allergic hypersensitive to experimental drugs or comparator drugs
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhongda Hospitallead
Study Sites (1)
Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, Southeast University
Nanjing, Jiangsu, China
Related Publications (1)
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.
PMID: 34049911DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zilin Sun, Ph.D.
Zhongda Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician, Professor of Medicine
Study Record Dates
First Submitted
February 16, 2020
First Posted
February 25, 2020
Study Start
March 1, 2020
Primary Completion
December 31, 2021
Study Completion
January 31, 2022
Last Updated
February 25, 2020
Record last verified: 2020-02