Clinical trial NCT04101604: Biomarkers of Common Eye Diseases
Official title: Using Next-Generation Sequencing Technology to Identify Biomarkers of Common Eye Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uveitis
Diabetic Retinopathy
Age-related Macular Degeneration
Polypoidal Choroidal Vasculopathy
VKH Syndrome
Behçet Disease
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects and patients who are diagnosed as DR, VKH, BD, AMD, or PCV will be enrolled.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Peripheral blood mononuclear cell (PBMC) signatures
timeFrame: 1 year
Secondary outcomes:
measure: PBMC cell types frequencies
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhognshan Ophthalmic Center, Sun Yat-sen University
name: Yingfeng Zheng
role: PRINCIPAL_INVESTIGATOR
References: