Diabetic RetinopathyPhase 4CALM-DRNCT04283162
Using Calcium Dobesilate to Treat Chinese Patients With Mild to Moderate Non-proliferative Diabetic Retinopathy
A Phase 4 study testing Calcium Dobesilate and conventional treatment in people with Diabetic Retinopathy, run by Zhongda Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Calcium Dobesilate and conventional treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 31 Jan 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with mild to moderate diabetic retinopathy
- Being older than 18 years
- Being willing to attend this trial.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Endocrinology, Zhongda Hospital, Institute of Diabetes, Southeast University
Nanjing, Jiangsu
About this study
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
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.
Read the 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
- Being tested
- Calcium Dobesilate, conventional treatment
- Keywords
- calcium dobesilate, mild to moderate non-proliferative diabetic retinopathy, cluster-randomized controlled trial
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium DobesilateDrug
Also called calcium dobesilate use
use calcium dobesilate at the dosage of 500 mg, orally, 3 times per day, for 12 months
conventional treatmentOther
Also called usual care
maintain lifestyle habits and the usual treatment
| Study group | Role | What they receive |
|---|---|---|
| conventional treatment plus calcium dobesilate | Experimental | maintain lifestyle habits and the usual treatment, plus the use of calcium dobesilate (500 mg, orally, 3 times per day) for 12 months Receives: Drug: Calcium Dobesilate; Other: conventional treatment |
| conventional treatment group | Active comparator | maintain lifestyle habits and the usual treatment for 12 months Receives: Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline to the end of treatment (12 months later)
Secondary outcomes (4)
Changes in eyesight
Changes in eyesight assessed by visual chart at 4 m by optometrists
Measured: 3-month, 6-month, and 12-month from baseline
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
Measured: 3-month, 6-month, and 12-month from baseline
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
Measured: 3-month, 6-month, and 12-month from baseline
Changes in metabolic biomarkers such as HbA1c
The metabolic biomarkers were assessed by laboratory measurement at different time-points
Measured: 3-month, 6-month, and 12-month from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zilin Sun, Zhongda Hospital
- Investigators
- Zilin Sun, Ph.D., Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283162
- Sponsor's protocol ID
- ZhongdaH-February
- Acronym
- CALM-DR
- Status last verified
- Feb 2020
- First submitted
- 16 Feb 2020
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34049911
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04283162
- Acronym / sponsor ID
- CALM-DR / ZhongdaH-February
- Conditions
- Diabetic Retinopathy
- Keywords
- calcium dobesilate, mild to moderate non-proliferative diabetic retinopathy, cluster-randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional treatment plus calcium dobesilate | Experimental | Drug: Calcium Dobesilate, Other: conventional treatmentmaintain 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 comparator | Other: conventional treatmentmaintain lifestyle habits and the usual treatment for 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being diagnosed with mild to moderate diabetic retinopathy
- Being older than 18 years
- Being willing to attend this trial.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium DobesilateAlso: calcium dobesilate useuse calcium dobesilate at the dosage of 500 mg, orally, 3 times per day, for 12 months | Drug | conventional treatment plus calcium dobesilate |
| conventional treatmentAlso: usual caremaintain lifestyle habits and the usual treatment | Other | conventional treatment group, conventional treatment plus calcium dobesilate |
Primary outcome
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.
4 secondary outcomes
Changes in eyesight
Time frame: 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
Changes in the retinal blood vessel diameter and arteriovenous ratio
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Derived from this study: PubMed 34049911Hu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zilin Sun, Ph.D. principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcium Dobesilate and conventional treatment in people with Diabetic Retinopathy, run by Zhongda Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zilin Sun, Ph.D. (008602583262813, sunzilin1963@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of the progression of diabetic retinopathy (time frame: from baseline to the end of treatment (12 months later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04283162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.