VKH SyndromeIPVNCT04025476
Immune Profile of Acute VKH Patients PBMC
An observational study of VKH Syndrome, run by Aier School of Ophthalmology, Central South University at 1 site in China.
Trial summary
The investigators will collect blood samples of different courses of VKH patients for investigating immune profile, observe major immune cells number ,functional and membrane molecular changes in the course of treatment, to investigate pathogenesis of VKH. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- VKH Syndrome
- What is being tested?
- Steroids
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2019to 7 Jul 2022
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: acute primary VKH patients
Who may be able to join
- Acute VKH patients, meet a criterion of VKH, no recurrence.
- Age range from 18 to 50 years old.
Who cannot join
- Patients with Severe Cardiovascular and Cerebrovascular Diseases
- Patients allergic to steroid or contrast agents;
- A history of ocular trauma or intraocular surgery within 3 months; Vaccinated; History of infectious diseases
- having a history of heredity, immune system correlation, neuroendocrine and digestive system diseases
- Patients who take health care products for a long time and have heavy alcohol and tobacco addiction.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuhan Aier eye hospital
Wuhan, Hubei, 430064
Zhaohui Li, Ph.D/MD, +86-186-2790-1441, lizhaohui@whu.edu.cn
Yafei Huang, Ph.D, +86-136-28627928, huangyf@tjh.tjmu.edu.cn
About this study
Official title: Clinical Observational Research on Changes of Peripheral Blood Mononuclear Cell（PBMC） Immunity and Expression Profile in Peripheral Blood of Different Course of of Vogt-Hoyanagi-Harada（VKH） Patients.
The investigators will collect blood samples of different courses of VKH patients for investigating immune profile, observe major immune cells number ,functional and membrane molecular changes in the course of treatment, to investigate pathogenesis of VKH. Meanwhile, the investigators will collect clinical data of VKH patients to observe choroid and retina change in different courses.
- Conditions
- VKH Syndrome
- Being tested
- Steroids
- Keywords
- VKH; immune profile;
- Medical subject headings
- Uveomeningoencephalitic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SteroidsDrug
IV and oral steroids
| Study group | Role | What they receive |
|---|---|---|
| VKH patients | acute VKH patients Receives: Drug: Steroids | |
| control | health people age/sex match to the VKH patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
T/B /NK(natural killer )/monocyte...etc, cell numbers of blood samples in VKH patients
use flow cytometry to count T/B /NK/monocyte...etc, cell numbers
Measured: one year
T/B /NK/monocyte...etc cell subtype proportion in blood samples in VKH patients
use flow cytometry to measure T/B /NK/monocyte...etc cell subtype proportion
Measured: one year
T/B /NK/monocyte...etc cell functional change in VKH patients
use ELISA(enzyme linked immunosorbent assay) to measure inflammatory cytokines level in peripheral blood
Measured: one year
Secondary outcomes (4)
choroid and retinal thickness change in different course of VKH patients
Use OCT（optical coherence tomography） to measure choroid and retina thickness changes in macular zone of different course VKH patients
Measured: one year
Use OCTA(optical coherence tomography angiography) to measure macular and optic disc vascular index
Use OCTA to measure macular and optic disc vascular index in different course VKH patients
Measured: one year
Use Maia perimeter to measure macular integrality
Use Maia perimeter to measure macular integrality including light threshold and central fixation.
Measured: one year
measure the Injury degree of choroid and retinal vessels
Use FFA(fluorescein fundus angiography)/ICG(Indocyanine Green Angiography) to measure the Injury degree of choroid and retinal vessels
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start20 Jul 2019 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion7 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VKH SyndromeStudies of the same condition, open and under way.
- 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aier School of Ophthalmology, Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qing Zhang, MD, Study director, Central-southern university, Aier ophthalmology colleage
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025476
- Sponsor's protocol ID
- AFM1713D1
- Acronym
- IPV
- Status last verified
- Jul 2019
- First submitted
- 14 Jul 2019
- Last updated
- 22 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observational Research on Changes of Peripheral Blood Mononuclear Cell（PBMC） Immunity and Expression Profile in Peripheral Blood of Different Course of of Vogt-Hoyanagi-Harada（VKH） Patients.
- ClinicalTrials.gov ID
- NCT04025476
- Acronym / sponsor ID
- IPV / AFM1713D1
- Conditions
- VKH Syndrome
- Keywords
- VKH; immune profile;
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Aier School of Ophthalmology, Central South UniversityUniversity, hospital or other
- Study start
- 20 Jul 2019 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 7 Jul 2022 (estimated)
- First posted
- 19 Jul 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.
The investigators will collect blood samples of different courses of VKH patients for investigating immune profile, observe major immune cells number ,functional and membrane molecular changes in the course of treatment, to investigate pathogenesis of VKH. Meanwhile, the investigators will collect clinical data of VKH patients to observe choroid and retina change in different courses.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VKH patients | – | Drug: Steroidsacute VKH patients |
| control | – | –health people age/sex match to the VKH patients |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- acute primary VKH patients
Key inclusion criteria (2 listed)
- Acute VKH patients, meet a criterion of VKH, no recurrence.
- Age range from 18 to 50 years old.
Key exclusion criteria (5 listed)
- Patients with Severe Cardiovascular and Cerebrovascular Diseases
- Patients allergic to steroid or contrast agents;
- A history of ocular trauma or intraocular surgery within 3 months; Vaccinated; History of infectious diseases
- having a history of heredity, immune system correlation, neuroendocrine and digestive system diseases
- Patients who take health care products for a long time and have heavy alcohol and tobacco addiction.
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 |
|---|---|---|
| SteroidsIV and oral steroids | Drug | VKH patients |
Primary outcome
T/B /NK(natural killer )/monocyte...etc, cell numbers of blood samples in VKH patients
Time frame: one year
use flow cytometry to count T/B /NK/monocyte...etc, cell numbers
T/B /NK/monocyte...etc cell subtype proportion in blood samples in VKH patients
Time frame: one year
use flow cytometry to measure T/B /NK/monocyte...etc cell subtype proportion
T/B /NK/monocyte...etc cell functional change in VKH patients
Time frame: one year
use ELISA(enzyme linked immunosorbent assay) to measure inflammatory cytokines level in peripheral blood
4 secondary outcomes
choroid and retinal thickness change in different course of VKH patients
Time frame: one year
Use OCTA(optical coherence tomography angiography) to measure macular and optic disc vascular index
Time frame: one year
Use Maia perimeter to measure macular integrality
Time frame: one year
measure the Injury degree of choroid and retinal vessels
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for VKH Syndrome
Recruiting
Early Immunosuppressive Therapy on the Course of Vogt-Koyanagi-Harada Disease
Vogt Koyanagi Harada Disease
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.
Qing Zhang, MD study director
Central-southern university, Aier ophthalmology colleage
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 VKH Syndrome, run by Aier School of Ophthalmology, Central South 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 5 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 22 Jul 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 Zhaohui Li, Ph.D/MD (+86-186-2790-1441, lizhaohui@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T/B /NK(natural killer )/monocyte...etc, cell numbers of blood samples in VKH patients (time frame: one year). The study lists 3 primary outcomes in all. 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 22 Jul 2019.