Immune Profile of Acute VKH Patients PBMC

VKH Syndrome Clinical Trial

— IPV  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04025476
• Other study ID #: AFM1713D1
• Status: Recruiting
• Start date: July 20, 2019
• Est. completion date: July 7, 2022

Study information

• Verified date: July 2019
• Source: Aier School of Ophthalmology, Central South University
• Contact: Zhaohui Li, Ph.D/MD
• Phone: +86-186-2790-1441
• Email: lizhaohui[@]whu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Meanwhile, the investigators will collect clinical data of VKH patients to observe choroid and retina change in different courses.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: July 7, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Acute VKH patients, meet a criterion of VKH, no recurrence.

2. Age range from 18 to 50 years old.

Exclusion Criteria:

1. Patients with Severe Cardiovascular and Cerebrovascular Diseases

2. Patients allergic to steroid or contrast agents;

3. A history of ocular trauma or intraocular surgery within 3 months; Vaccinated; History of infectious diseases

4. having a history of heredity, immune system correlation, neuroendocrine and digestive system diseases

5. Patients who take health care products for a long time and have heavy alcohol and tobacco addiction.

Related Conditions & MeSH terms

• Uveomeningoencephalitic Syndrome
• VKH Syndrome

Intervention

Drug:
• Steroids
IV and oral steroids

Locations

Country	Name	City	State
China	Wuhan Aier eye hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Aier School of Ophthalmology, Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one year
Primary	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	one year
Primary	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	one year
Secondary	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	one year
Secondary	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	one year
Secondary	Use Maia perimeter to measure macular integrality	Use Maia perimeter to measure macular integrality including light threshold and central fixation.	one year
Secondary	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	one year