Diabetic RetinopathySBDESNCT03571217
Shanghai Beixinjing Diabetic Eyes Study
An observational study of Diabetic Retinopathy and Visual Impairment, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
In industrialized nations diabetic retinopathy(DR) is the most frequent microvascular complication of type 2 diabetes mellitus and the leading cause of visual impairment and blindness in the working-age population. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Diabetic Retinopathy, Visual Impairment, Diabetic Maculopathy
- How many people
- 2,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2014to 31 Dec 2024
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: Type 2 diabetes mellitus. Diabetes mellitus (DM) was defined as either blood hemoglobin A1C≥6.5%, use of diabetic medication or a physician diagnosis of diabetes.
Who may be able to join
- ≥18 years old;
- Diabetes mellitus (DM) was defined as either blood hemoglobin A1C≥6.5%, use of diabetic medication or a physician diagnosis of diabetes.
Who cannot join
- None;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Eye Disease Prevention & Treatment Center
Shanghai, Shanghai Municipality, 200040
Haidong Zou, Ph.D, 8613311986528, zouhaidong@263.net
About this study
Official title: The Cohort Study of Incidence and Disk Factors of Diabetic Retinopathy and Visual Impairment in Adults With Type 2 Diabetes
In industrialized nations diabetic retinopathy(DR) is the most frequent microvascular complication of type 2 diabetes mellitus and the leading cause of visual impairment and blindness in the working-age population. The well-accepted strategy for prevention and treatment of diabetic eye complications focused on confirmed diabetic retinopathy, diabetic macular edema, cataract, etc, and there was no definitive therapy for preclinical central visual acuity (CVA) impairment, mainly because of its unknown pathogenesis. In our previous population-based study, the prevalence rate of early CVA impairment was as high as 9.1%, and that obviously limits the effects of diabetic eye diseases prevention and early-stage treatment strategy. Of note, the choriocapillaris is the only route for metabolic exchange in the retina within the foveal avascular zone, it was speculated that early CVA impairment is related to diabetic choroidopathy (DC). Recent research shows that the decreased macular choriocapillaris vessel density (MCVD) in diabetic eye ,which indicating early ischemia, is already present before diabetic macular edema can be observed; we have observed subfoveal choroidal thickness (SFCT) decreased significantly in the early CVA impairment patients. However, up til now, there was no epidemiology report on early CVA impairment in Chinese diabetes population. In the present study, we plan to conduct a 10-year perspective cohort observation of 2217 Chinese type 2 diabetic residents without diabetic retinopathy, diabetic macular edema, cataract and other vision impairing diseases, trying to find out related physical and biochemical risk factors. The results will facilitate discriminating high risk groups of early CVA impairment in diabetic patients. In the same time, a quantitative relationship between SFCT change, MCVD change and CVA change will be established. This study will demonstrate the role of DC in the occurrence of preclinical CVA impairment, and provide important theoretic evidence of blocking agents which target on DC.
- Keywords
- Type 2 diabetes mellitus, diabetic retinopathy, visual impairment, diabetic choroidopathy
- Medical subject headings
- Diabetic Retinopathy, Vision Disorders, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic retinopathy cohort | Not described | |
| Mild visual impairment cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetic retinopathy
The DR grades are according to the well-accepted ''International Clinical Diabetic Retinopathy and Diabetic Macular Edema Disease Severity Scale''
Measured: December 31，2024
mild visual impairment
Mild visual impairment was present if BCVA was < 20/25 but ≥ 20/63.
Measured: December 31，2024
macular choriocapillaris vessel density(MCVD)
macular choriocapillaris vessel density
Measured: December 31，2024
glycosylated hemoglobin
This test measures the average blood sugar control for the previous three months or so.
Measured: December 31，2024
retinal thickness (RT)
Retinal thickness was defined as the distance from the internal limiting membrane to the interface of the photoreceptor outer segments and retinal pigment epithelium.
Measured: December 31，2024
choroidal thickness (CT)
Choroidal thickness was measured from the outer border of the RPE to the inner border of the choroidoscleral interface.
Measured: December 31，2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start1 Oct 2014
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haidong Zou, MD, PhD, Study chair, Shanghai Eye Disease Prevention & Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571217
- Sponsor's protocol ID
- YFZX2018003
- Acronym
- SBDES
- Status last verified
- Jun 2018
- First submitted
- 18 Jun 2018
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cohort Study of Incidence and Disk Factors of Diabetic Retinopathy and Visual Impairment in Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03571217
- Acronym / sponsor ID
- SBDES / YFZX2018003
- Keywords
- Type 2 diabetes mellitus, diabetic retinopathy, visual impairment, diabetic choroidopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Jun 2018 (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.
In industrialized nations diabetic retinopathy(DR) is the most frequent microvascular complication of type 2 diabetes mellitus and the leading cause of visual impairment and blindness in the working-age population. The well-accepted strategy for prevention and treatment of diabetic eye complications focused on confirmed diabetic retinopathy, diabetic macular edema, cataract, etc, and there was no definitive therapy for preclinical central visual acuity (CVA) impairment, mainly because of its unknown pathogenesis. In our previous population-based study, the prevalence rate of early CVA impairment was as high as 9.1%, and that obviously limits the effects of diabetic eye diseases prevention and early-stage treatment strategy. Of note, the choriocapillaris is the only route for metabolic exchange in the retina within the foveal avascular zone, it was speculated that early CVA impairment is related to diabetic choroidopathy (DC). Recent research shows that the decreased macular choriocapillaris vessel density (MCVD) in diabetic eye ,which indicating early ischemia, is already present before diabetic macular edema can be observed; we have observed subfoveal choroidal thickness (SFCT) decreased significantly in the early CVA impairment patients. However, up til now, there was no epidemiology report on early CVA impairment in Chinese diabetes population. In the present study, we plan to conduct a 10-year perspective cohort observation of 2217 Chinese type 2 diabetic residents without diabetic retinopathy, diabetic macular edema, cataract and other vision impairing diseases, trying to find out related physical and biochemical risk factors. The results will facilitate discriminating high risk groups of early CVA impairment in diabetic patients. In the same time, a quantitative relationship between SFCT change, MCVD change and CVA change will be established. This study will demonstrate the role of DC in the occurrence of preclinical CVA impairment, and provide important theoretic evidence of blocking agents which target on DC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic retinopathy cohort | – | – |
| Mild visual impairment cohort | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetes mellitus. Diabetes mellitus (DM) was defined as either blood hemoglobin A1C≥6.5%, use of diabetic medication or a physician diagnosis of diabetes.
Key inclusion criteria (2 listed)
- ≥18 years old;
- Diabetes mellitus (DM) was defined as either blood hemoglobin A1C≥6.5%, use of diabetic medication or a physician diagnosis of diabetes.
Key exclusion criteria (1 listed)
- None;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diabetic retinopathy
Time frame: December 31，2024
The DR grades are according to the well-accepted ''International Clinical Diabetic Retinopathy and Diabetic Macular Edema Disease Severity Scale''
mild visual impairment
Time frame: December 31，2024
Mild visual impairment was present if BCVA was < 20/25 but ≥ 20/63.
macular choriocapillaris vessel density(MCVD)
Time frame: December 31，2024
macular choriocapillaris vessel density
glycosylated hemoglobin
Time frame: December 31，2024
This test measures the average blood sugar control for the previous three months or so.
retinal thickness (RT)
Time frame: December 31，2024
Retinal thickness was defined as the distance from the internal limiting membrane to the interface of the photoreceptor outer segments and retinal pigment epithelium.
choroidal thickness (CT)
Time frame: December 31，2024
Choroidal thickness was measured from the outer border of the RPE to the inner border of the choroidoscleral interface.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
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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.
Haidong Zou, MD, PhD study chair
Shanghai Eye Disease Prevention & Treatment Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy and Visual Impairment, run by Shanghai Eye Disease Prevention and Treatment Center 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 2 inclusion and 1 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 27 Jun 2018. 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.
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 Haidong Zou, MD, PhD (8613311986528, zouhaidong@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetic retinopathy (time frame: December 31，2024). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2018; AzTrials last refreshed its copy on 3 Nov 2026.