UveitisNCT04101604
Biomarkers of Common Eye Diseases
An observational study of Uveitis and Diabetic Retinopathy, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Uveitis, Diabetic Retinopathy, Age-related Macular Degeneration
- What is being tested?
- Collection of blood samples
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 26 Sep 2019to 1 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects and patients who are diagnosed as DR, VKH, BD, AMD, or PCV will be enrolled.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Yizhi Liu contact
China1 site, 1 recruiting
- Recruiting
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Yingfeng Zheng, +8613922286455, zhyfeng@mail.sysu.edu.cn
About this study
Official title: Using Next-Generation Sequencing Technology to Identify Biomarkers of Common Eye Diseases
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.
Read the 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.
- Conditions
- Uveitis, Diabetic Retinopathy, Age-related Macular Degeneration, Polypoidal Choroidal Vasculopathy, VKH Syndrome, Behçet Disease
- Being tested
- Collection of blood samples
- Medical subject headings
- Uveitis, Diabetic Retinopathy, Macular Degeneration, Polypoidal Choroidal Vasculopathy, Uveomeningoencephalitic Syndrome, Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of blood samplesOther
Collection of blood samples for DNA extraction and genetic characterization, and for identification of peripheral blood biomarkers using single-cell transcriptomics and mass cytometry.
| Study group | Role | What they receive |
|---|---|---|
| Patients with VKH, BD, DR, AMD, or PCV | Collection of blood samples and clinical information from patients with VKH, BD, DR, AMD, or PCV Receives: Other: Collection of blood samples | |
| Healthy subjects | Collection of blood samples and clinical information Receives: Other: Collection of blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start26 Sep 2019
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingfeng Zheng, Sun Yat-sen University
- Investigators
- Yingfeng Zheng, Principal investigator, Zhognshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101604
- Sponsor's protocol ID
- 2019KYPJ114
- Status last verified
- Sep 2019
- First submitted
- 20 Sep 2019
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Next-Generation Sequencing Technology to Identify Biomarkers of Common Eye Diseases
- ClinicalTrials.gov ID
- NCT04101604
- Acronym / sponsor ID
- 2019KYPJ114
- Conditions
- Uveitis, Diabetic Retinopathy, Age-related Macular Degeneration, Polypoidal Choroidal Vasculopathy, VKH Syndrome, Behçet Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with VKH, BD, DR, AMD, or PCV | – | Other: Collection of blood samplesCollection of blood samples and clinical information from patients with VKH, BD, DR, AMD, or PCV |
| Healthy subjects | – | Other: Collection of blood samplesCollection of blood samples and clinical information |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects and patients who are diagnosed as DR, VKH, BD, AMD, or PCV will be enrolled.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of blood samplesCollection of blood samples for DNA extraction and genetic characterization, and for identification of peripheral blood biomarkers using single-cell transcriptomics and mass cytometry. | Other | Healthy subjects, Patients with VKH, BD, DR, AMD, or PCV |
Primary outcome
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.
1 secondary outcome
PBMC cell types frequencies
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yizhi Liu contact
Yingfeng Zheng principal investigator
Zhognshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uveitis and Diabetic Retinopathy, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingfeng Zheng (+8613922286455, zhyfeng@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral blood mononuclear cell (PBMC) signatures (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.