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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04283162
Recruitment Status : Not yet recruiting
First Posted : February 25, 2020
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Zilin Sun, Zhongda Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Drug: Calcium Dobesilate Other: conventional treatment Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


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 Name: calcium dobesilate use

Other: conventional treatment
maintain lifestyle habits and the usual treatment
Other Name: 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 Name: usual care




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283162


Contacts
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Contact: Zilin Sun, Ph.D. 008602583262813 sunzilin1963@126.com

Locations
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China, Jiangsu
Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, Southeast University
Nanjing, Jiangsu, China
Sponsors and Collaborators
Zhongda Hospital
Investigators
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Principal Investigator: Zilin Sun, Ph.D. Zhongda Hospital
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Responsible Party: Zilin Sun, Chief Physician, Professor of Medicine, Zhongda Hospital
ClinicalTrials.gov Identifier: NCT04283162    
Other Study ID Numbers: ZhongdaH-February
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zilin Sun, Zhongda Hospital:
calcium dobesilate
mild to moderate non-proliferative diabetic retinopathy
cluster-randomized controlled trial
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Calcium, Dietary
Calcium Dobesilate
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Hemostatics
Coagulants