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Biomarkers of Common Eye Diseases

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ClinicalTrials.gov Identifier: NCT04101604
Recruitment Status : Recruiting
First Posted : September 24, 2019
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Yingfeng Zheng, Sun Yat-sen University

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.

Condition or disease Intervention/treatment
Uveitis Diabetic Retinopathy Age-related Macular Degeneration Polypoidal Choroidal Vasculopathy VKH Syndrome Behçet Disease Other: Collection of blood samples

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.

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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Using Next-Generation Sequencing Technology to Identify Biomarkers of Common Eye Diseases
Actual Study Start Date : September 26, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2021


Group/Cohort Intervention/treatment
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
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
Collection of blood samples and clinical information
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.




Primary Outcome Measures :
  1. Peripheral blood mononuclear cell (PBMC) signatures [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. PBMC cell types frequencies [ Time Frame: 1 year ]
    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.


Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy subjects and patients who are diagnosed as DR, VKH, BD, AMD, or PCV will be enrolled.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04101604


Contacts
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Contact: Yingfeng Zheng +8613922286455 zhyfeng@mail.sysu.edu.cn
Contact: Yizhi Liu

Locations
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China, Guangdong
Zhognshan Ophthalmic Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Yingfeng Zheng    +8613922286455    zhyfeng@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Yingfeng Zheng Zhognshan Ophthalmic Center, Sun Yat-sen University
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Responsible Party: Yingfeng Zheng, Clinical investigator, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04101604    
Other Study ID Numbers: 2019KYPJ114
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Behcet Syndrome
Uveomeningoencephalitic Syndrome
Macular Degeneration
Diabetic Retinopathy
Uveitis
Eye Diseases
Retinal Degeneration
Retinal Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Uveal Diseases
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Vasculitis
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Autoimmune Diseases
Immune System Diseases