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NCT07098832Not yet recruiting

Multimodal Biomarkers in Prediction of Diabetic Retinopathy

Application of Multimodal Biomarkers in Early Diagnosis and Progression Prediction of Diabetic Retinopathy: A Prospective Cohort Study

Source: ClinicalTrials.gov · Last updated 1 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
1538 (estimated)
First submitted
10 Jul 2025
Start date
Jul 2025
Primary completion date
Dec 2030
Lead sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
NCT number
NCT07098832

What you commit to

  • Study type: Observational
  • Planned participants: 1538
  • From Jul 2025 to the primary completion date, Dec 2030
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • A history of previous ocular surgery.

Other illness

  • 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.

Age

  • Complicated with other severe ocular diseases (e.g., glaucoma, age-related macular degeneration, uveitis, etc.).

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zhongshan Ophthalmic Center,Sun Yat-Sen University
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.