Multimodal Biomarkers in Prediction of Diabetic Retinopathy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

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.

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,538 Participants
are grouped into 5 trial groups
Group A: Idiopathic Epiretinal Membrane (iERM) Group
Group B: Healthy Control Group
Group C: Proliferative Diabetic Retinopathy (PDR) Group
Group D: Non-Proliferative Diabetic Retinopathy (NPDR) Group
Group E: No Diabetic Retinopathy (NDR) Group

Trial outcomes

Primary outcomes

1

The progression of diabetic retinopathy during the follow-up period.

Time frame
From baseline to study completion, an average of 5 years.

Secondary outcomes

1

Changes in best-corrected visual acuity during the follow-up period.

Time frame
From baseline to study completion, an average of 5 years.
2

Changes in ocular functional indicators during the follow-up period.

Time frame
From baseline to study completion, an average of 5 years.
3

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.
4

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.

Other outcomes

Sponsors and contacts

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