Diabetic Retinopathy (DR)ZOCDRNCT07098832
Multimodal Biomarkers in Prediction of Diabetic Retinopathy
An observational study of Diabetic Retinopathy (DR), run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this observational study is to enroll diabetic patients with diabetic retinopathy and those without diabetic retinopathy, follow up and observe the long-term changes in ocular structure and function of the subjects by comparison, analyze their association with multimodal biomarkers, and explore new methods… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy (DR)
- How many people
- 1,538 participants
- Where
- 1 siteChina
- Study dates
- Jul 2025to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants are planned to be enrolled from the outpatient department of Zhongshan Ophthalmic Center, as well as community populations in Guangzhou and surrounding provinces and cities.
Who may be able to join
- Participants must understand the clinical trial, voluntarily participate, and sign the informed consent form.
- Aged 18-80 years, with no restriction on gender.
- Healthy control group: No history or diagnosis of diabetes.
- Diabetic group:
- Definite diagnosis of diabetes. Both type 1 and type 2 diabetic patients will be included in this study.
- Based on dilated fundus examination, subjects are classified into NDR, NPDR, and PDR groups according to the staging of diabetic retinopathy.
- Idiopathic epiretinal membrane (iERM) group is set as the control group for intraocular specimen collection and analysis in PDR patients: Funduscopic examination shows gold foil-like reflection or glass membrane-like substance covering the macular area, causing local retinal folds, with or without tortuosity and deformation of small perimacular blood vessels; OCT examination reveals a hyperreflective band on the retinal surface of the macular area; meeting the indications for pars plana vitrectomy combined with internal limiting membrane-epiretinal membrane peeling: visual acuity < 0.3, or visual acuity > 0.5 but accompanied by progressive vision loss, severe metamorphopsia, diplopia, visual field defect, or other symptoms that significantly affect quality of life, and surgical treatment can be performed if actively requested by the patient; no diagnosis or history of diabetes.
Who cannot join
- Complicated with other severe ocular diseases (e.g., glaucoma, age-related macular degeneration, uveitis, etc.).
- A history of previous ocular surgery.
- Complicated with severe systemic diseases (e.g., ischemic heart disease, stroke, malignant tumor, and severe liver or kidney diseases) or a history of systemic surgery (e.g., coronary artery bypass grafting, arterial/venous thrombolysis, organ transplantation, etc.).
- Complicated with cognitive impairment (MMSE score < 24), mental illness (e.g., schizophrenia, bipolar disorder), or inability to cooperate with questionnaires and ophthalmic examinations due to language comprehension deficits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Clinical Research Center, Zhongshan Ophthalmic Center, +86-020-66610720, zoccrc@mail.sysu.edu.cn
About this study
Official title: Application of Multimodal Biomarkers in Early Diagnosis and Progression Prediction of Diabetic Retinopathy: A Prospective Cohort Study
The goal of this observational study is to enroll diabetic patients with diabetic retinopathy and those without diabetic retinopathy, follow up and observe the long-term changes in ocular structure and function of the subjects by comparison, analyze their association with multimodal biomarkers, and explore new methods for the early diagnosis and risk prediction of diabetic retinopathy.
Participants will be followed up over a 5-year follow-up period, during which they will undergo ophthalmic examinations, blood tests, and questionnaires.
- Conditions
- Diabetic Retinopathy (DR)
- Keywords
- Diabetic Retinopathy, Prospective cohort, Multimodal biomarker
- Medical subject headings
- Diabetic Retinopathy
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 |
|---|---|---|
| Idiopathic Epiretinal Membrane (iERM) Group | No additional interventions will be performed. Only the waste fluid generated during the normal surgical procedures of patients requiring surgery will be collected for control purposes (this will not affect surgical safety or prognosis of the patients). | |
| Healthy Control Group | For participants in this group, only anonymous examination data were collected. | |
| Proliferative Diabetic Retinopathy (PDR) Group | Disease group, only collect anonymous examination data, and collect the waste fluid generated during the normal surgical procedures of patients requiring surgery will be collected (this will not affect surgical safety or prognosis of the patients). | |
| Non-Proliferative Diabetic Retinopathy (NPDR) Group | Disease group, for participants in this group, only anonymous examination data were collected. | |
| No Diabetic Retinopathy (NDR) Group | For participants in this group, only anonymous examination data were collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The progression of diabetic retinopathy during the follow-up period.
Measured: From baseline to study completion, an average of 5 years.
Secondary outcomes (6)
Changes in best-corrected visual acuity during the follow-up period.
Measured: From baseline to study completion, an average of 5 years.
Changes in ocular functional indicators during the follow-up period.
Measured: From baseline to study completion, an average of 5 years.
Changes in ocular fundus structure during follow-up as indicated by optical coherence tomography (OCT) examination.
Measured: From baseline to study completion, an average of 5 years.
Changes in ocular fundus blood flow during follow-up by optical coherence as indicated by tomography angiography (OCTA) examination.
Measured: From baseline to study completion, an average of 5 years.
Blood and intraocular fluid metabolite concentrations measured by metabolomics during follow-up.
Measured: From baseline to study completion, an average of 5 years.
Blood and intraocular fluid protein concentrations measured by proteomics during follow-up.
Measured: From baseline to study completion, an average of 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study startJul 2025 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Retinopathy (DR)Studies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- 1,538 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Tao, MD, PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098832
- Sponsor's protocol ID
- 2025KYPJ064
- Acronym
- ZOCDR
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Multimodal Biomarkers in Early Diagnosis and Progression Prediction of Diabetic Retinopathy: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07098832
- Acronym / sponsor ID
- ZOCDR / 2025KYPJ064
- Conditions
- Diabetic Retinopathy (DR)
- Keywords
- Diabetic Retinopathy, Prospective cohort, Multimodal biomarker
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,538 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 1 Aug 2025 (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.
The goal of this observational study is to enroll diabetic patients with diabetic retinopathy and those without diabetic retinopathy, follow up and observe the long-term changes in ocular structure and function of the subjects by comparison, analyze their association with multimodal biomarkers, and explore new methods for the early diagnosis and risk prediction of diabetic retinopathy.
Participants will be followed up over a 5-year follow-up period, during which they will undergo ophthalmic examinations, blood tests, and questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Idiopathic Epiretinal Membrane (iERM) Group | – | –No additional interventions will be performed. Only the waste fluid generated during the normal surgical procedures of patients requiring surgery will be collected for control purposes (this will not affect surgical safety or prognosis of the patients). |
| Healthy Control Group | – | –For participants in this group, only anonymous examination data were collected. |
| Proliferative Diabetic Retinopathy (PDR) Group | – | –Disease group, only collect anonymous examination data, and collect the waste fluid generated during the normal surgical procedures of patients requiring surgery will be collected (this will not affect surgical safety or prognosis of the patients). |
| Non-Proliferative Diabetic Retinopathy (NPDR) Group | – | –Disease group, for participants in this group, only anonymous examination data were collected. |
| No Diabetic Retinopathy (NDR) Group | – | –For participants in this group, only anonymous examination data were collected. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are planned to be enrolled from the outpatient department of Zhongshan Ophthalmic Center, as well as community populations in Guangzhou and surrounding provinces and cities.
Key inclusion criteria (7 listed)
- Participants must understand the clinical trial, voluntarily participate, and sign the informed consent form.
- Aged 18-80 years, with no restriction on gender.
- Healthy control group: No history or diagnosis of diabetes.
- Diabetic group:
- Based on dilated fundus examination, subjects are classified into NDR, NPDR, and PDR groups according to the staging of diabetic retinopathy.
Key exclusion criteria (4 listed)
- Complicated with other severe ocular diseases (e.g., glaucoma, age-related macular degeneration, uveitis, etc.).
- A history of previous ocular surgery.
- Complicated with severe systemic diseases (e.g., ischemic heart disease, stroke, malignant tumor, and severe liver or kidney diseases) or a history of systemic surgery (e.g., coronary artery bypass grafting, arterial/venous thrombolysis, organ transplantation, etc.).
- Complicated with cognitive impairment (MMSE score < 24), mental illness (e.g., schizophrenia, bipolar disorder), or inability to cooperate with questionnaires and ophthalmic examinations due to language comprehension deficits.
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
The progression of diabetic retinopathy during the follow-up period.
Time frame: From baseline to study completion, an average of 5 years.
6 secondary outcomes
Changes in best-corrected visual acuity during the follow-up period.
Time frame: From baseline to study completion, an average of 5 years.
Changes in ocular functional indicators during the follow-up period.
Time frame: From baseline to study completion, an average of 5 years.
Changes in ocular fundus structure during follow-up as indicated by optical coherence tomography (OCT) examination.
Time frame: From baseline to study completion, an average of 5 years.
Changes in ocular fundus blood flow during follow-up by optical coherence as indicated by tomography angiography (OCTA) examination.
Time frame: From baseline to study completion, an average of 5 years.
Blood and intraocular fluid metabolite concentrations measured by metabolomics during follow-up.
Time frame: From baseline to study completion, an average of 5 years.
Blood and intraocular fluid protein concentrations measured by proteomics during follow-up.
Time frame: From baseline to study completion, an average of 5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Li Tao, MD, PhD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
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 (DR), run by Zhongshan Ophthalmic Center, Sun Yat-sen University 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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 1 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Tao, MD, PhD (+86-13724865499, litao2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The progression of diabetic retinopathy during the follow-up period. (time frame: From baseline to study completion, an average of 5 years.). 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 1 Aug 2025.