Multimodal Biomarkers in Prediction of Diabetic Retinopathy (ZOCDR)

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Diabetic Retinopathy (DR)

Study type: Observational

Funder types: Other

Identifiers

NCT07098832

2025KYPJ064

Details and patient eligibility

About

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.

Enrollment: 1,538 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,538 participants in 5 patient groups

Idiopathic Epiretinal Membrane (iERM) Group

Description:

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

Description:

For participants in this group, only anonymous examination data were collected.

Proliferative Diabetic Retinopathy (PDR) Group

Description:

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

Description:

Disease group, for participants in this group, only anonymous examination data were collected.

No Diabetic Retinopathy (NDR) Group

Description:

For participants in this group, only anonymous examination data were collected.