Multimodal Biomarkers in Prediction of Diabetic Retinopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diabetic Retinopathy (DR). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Application of Multimodal Biomarkers in Early Diagnosis and Progression Prediction of Diabetic Retinopathy: A Prospective Cohort Study
Overview
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.
Primary outcome measures
- The progression of diabetic retinopathy during the follow-up period. [Time frame: From baseline to study completion, an average of 5 years.]
Secondary outcome measures (6)
- 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.]
Eligibility criteria
Inclusion criteria
- 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:
i) Definite diagnosis of diabetes. Both type 1 and type 2 diabetic patients will be included in this study.
ii) 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Zhongshan Ophthalmic Center, Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT07098832 · 2025KYPJ064