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NCT Number: NCT07098832

Multimodal Biomarkers in Prediction of Diabetic Retinopathy

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location contact

Clinical Research Center, Zhongshan Ophthalmic Center

CONTACT

[email protected]

+86-020-66610720

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

  5. Blood and intraocular fluid metabolite concentrations measured by metabolomics during follow-up.

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

  6. Blood and intraocular fluid protein concentrations measured by proteomics during follow-up.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Kangjie Kong, MD, PhD

CONTACT

[email protected]

+86-15623426876

Li Tao, MD, PhD

CONTACT

[email protected]

+86-13724865499

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study title

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

Acronym: ZOCDR

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Aug 1, 2025
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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