Biomarkers of Common Eye Diseases

NCT04101604 | Unknown DMC

• 1 other identifier: 2019KYPJ114
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

To identify biomarkers of common eye diseases based on single-cell sequencing technologies using PBMC samples. These diseases include uveitis, diabetic retinopathy, age-related macular degeneration and polypoid choroidal vasculopathy. Our study may provide new insight into the underlying mechanisms, and reveal novel predictors and intervention targets for the diagnosis, prognosis and treatment of these diseases.

Conditions

Uveitis; Diabetic Retinopathy; Age-related Macular Degeneration; Polypoidal Choroidal Vasculopathy; VKH Syndrome; Behçet Disease

Outcome Measures

Primary Outcomes (1)

• Peripheral blood mononuclear cell (PBMC) signatures

  PBMC signatures, derived from single cell sequencing and mass spectrometry, will be compared for the same patient before and after treatment, among patients of different symptoms and severity measures, and also between patients and healthy subjects. Upon these comparisons, biomarkers will be established for the patient population.

  1 year

Secondary Outcomes (1)

• PBMC cell types frequencies

  1 year

Study Arms (2)

Patients with VKH, BD, DR, AMD, or PCV

Collection of blood samples and clinical information from patients with VKH, BD, DR, AMD, or PCV

Other: Collection of blood samples

Healthy subjects

Collection of blood samples and clinical information

Other: Collection of blood samples

Interventions

Collection of blood samples OTHER

Collection of blood samples for DNA extraction and genetic characterization, and for identification of peripheral blood biomarkers using single-cell transcriptomics and mass cytometry.

Healthy subjects; Patients with VKH, BD, DR, AMD, or PCV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects and patients who are diagnosed as DR, VKH, BD, AMD, or PCV will be enrolled.

You may qualify if:

• Age over 18 (including 18 years old);
• Clinically diagnosed as diabetic retinopathy (DR), uveitis (VKH or BD) , age-related macular degeneration (AMD) , or polypoid choroidal vasculopathy (PCV)

You may not qualify if:

• Have received more than 2 intravitreal injections of anti-VEGF drugs because of retinal or choroidal neovascularization and macular edema;
• Patients with stable condition after having undergone panretinal laser photocoagulation and pars plana vitrectomy (PPV);
• There are other serious systemic diseases of the body, such as history of chronic kidney disease requiring dialysis or a kidney transplant, unstable blood pressure, cardiovascular disease, tumors, etc;
• Patients who are pregnant or nursing

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Uveitis; Diabetic Retinopathy; Macular Degeneration; Polypoidal Choroidal Vasculopathy; Uveomeningoencephalitic Syndrome; Behcet Syndrome

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Retinal Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Retinal Degeneration; Choroidal Neovascularization; Choroid Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Vasculitis; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Study Officials

• Yingfeng Zheng

  Zhognshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingfeng Zheng

CONTACT

+8613922286455; zhyfeng@mail.sysu.edu.cn

Yizhi Liu

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical investigator

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 24, 2019
• Study Start: September 26, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2021
• Last Updated: September 27, 2019

Record last verified: 2019-09

Locations

CN (1)