Biomarkers of Common Eye Diseases

Diabetic Retinopathy Clinical Trial

Official title:

Using Next-Generation Sequencing Technology to Identify Biomarkers of Common Eye Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04101604
• Other study ID #: 2019KYPJ114
• Status: Recruiting
• Start date: September 26, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: September 2019
• Source: Sun Yat-sen University
• Contact: Yingfeng Zheng
• Phone: +8613922286455
• Email: zhyfeng[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The pathogenesis of common eye diseases such as uveitis (including Behcet's disease (BD) and Vogt-Koyanagi-Harada disease (VKH)), diabetic retinopathy (DR), age-related macular degeneration (AMD) and polypoid choroidal vasculopathy (PCV) remains unknown. Although immunosuppressants, anti-vascular endothelial growth factor (VEGF) agents, and pars plana vitrectomy (PPV) have been widely used for treatment, the current therapeutic options are limited. In addition, there is a lack of biomarkers to indicate the prognosis and treatment response of these diseases. The aim of this study is to identify biomarkers and to provide a new target for individualized diagnosis and treatment of common eye diseases based on single cell sequencing technology.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for patients:

1. Age over 18 (including 18 years old);

2. Clinically diagnosed as diabetic retinopathy (DR), uveitis (VKH or BD) , age-related macular degeneration (AMD) , or polypoid choroidal vasculopathy (PCV)

Exclusion Criteria for patients with retinal diseases:

1. Have received more than 2 intravitreal injections of anti-VEGF drugs because of retinal or choroidal neovascularization and macular edema;

2. Patients with stable condition after having undergone panretinal laser photocoagulation and pars plana vitrectomy (PPV);

3. 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;

4. Patients who are pregnant or nursing

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Behçet Disease
• Behcet Syndrome
• Diabetic Retinopathy
• Eye Diseases
• Macular Degeneration
• Polypoidal Choroidal Vasculopathy
• Uveitis
• Uveomeningoencephalitic Syndrome
• VKH Syndrome

Intervention

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

Locations

Country	Name	City	State
China	Zhognshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PBMC cell types frequencies	PBMC cell types frequencies, 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.	1 year