Immune Profile of Acute VKH Patients PBMC (IPV)

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.

Study Overview

• Status: Unknown
• Conditions: VKH Syndrome
• Intervention / Treatment: Drug: Steroids

• Study Type: Observational
• Enrollment (Anticipated): 48

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430064
      • Recruiting
      • Wuhan Aier Eye Hospital
      • Contact: Zhaohui Li, Ph.D/MD; Phone Number: +86-186-2790-1441; Email: lizhaohui@whu.edu.cn
      • Contact: Yafei Huang, Ph.D; Phone Number: +86-136-28627928; Email: huangyf@tjh.tjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

acute primary VKH patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VKH patients; acute VKH patients	Drug: Steroids; IV and oral steroids
control; health people age/sex match to the VKH patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Use Maia perimeter to measure macular integrality	Use Maia perimeter to measure macular integrality including light threshold and central fixation.	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	one year

Collaborators and Investigators

• Sponsor: Aier School of Ophthalmology, Central South University
• Investigators: Study Director: Qing Zhang, MD, Central-southern university, Aier ophthalmology colleage

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 20, 2019
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): July 7, 2022

Study Registration Dates

• First Submitted: July 14, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (ACTUAL): July 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2019
• Last Update Submitted That Met QC Criteria: July 19, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: VKH; immune profile
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Eye Diseases; Uveitis; Uveal Diseases; Uveomeningoencephalitic Syndrome
• Other Study ID Numbers: AFM1713D1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No