Studies eye and blood markers to spot diabetic eye disease early
Follows adults with diabetes, with and without eye damage, for 5 years.
Plain-language title generated from the registry record
Registry title: Multimodal Biomarkers in Prediction of Diabetic Retinopathy
Key facts
- Where
- Guangzhou, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07098832, who can take part
Where in China
- Zhongshan Ophthalmic Center,Sun Yat-Sen UniversityGuangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Trial code
- NCT07098832
- Record updated
- 1 August 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; Complicated with other severe ocular diseases (e.g., glaucoma, age-related macular degeneration, uveitis, etc.).