Immune Profile of Acute VKH Patients PBMC

NCT04025476 | Unknown

• 1 other identifier: AFM1713D1
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

VKH Syndrome

Keywords

VKH; immune profile;

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• choroid and retinal thickness change in different course of VKH patients

  one year

• Use OCTA(optical coherence tomography angiography) to measure macular and optic disc vascular index

  one year

• Use Maia perimeter to measure macular integrality

  one year

• measure the Injury degree of choroid and retinal vessels

  one year

Study Arms (2)

VKH patients

acute VKH patients

Drug: Steroids

control

health people age/sex match to the VKH patients

Interventions

Steroids DRUG

IV and oral steroids

VKH patients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

acute primary VKH patients

You may qualify if:

• Acute VKH patients, meet a criterion of VKH, no recurrence.
• Age range from 18 to 50 years old.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aier School of Ophthalmology, Central South University: lead

Study Sites (1)

Wuhan Aier eye hospital

Wuhan, Hubei, 430064, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood sample of VKH patients

MeSH Terms

Conditions

Uveomeningoencephalitic Syndrome

Interventions

Steroids

Condition Hierarchy (Ancestors)

Autoimmune Diseases of the Nervous System; Nervous System Diseases; Uveitis; Uveal Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Qing Zhang, MD

  Central-southern university, Aier ophthalmology colleage

  STUDY DIRECTOR

Central Study Contacts

Zhaohui Li, Ph.D/MD

CONTACT

+86-186-2790-1441; lizhaohui@whu.edu.cn

Yafei Huang, Ph.d

CONTACT

+86-136-2862-7928; huangyf@tjh.tjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2019
• First Posted: July 19, 2019
• Study Start: July 20, 2019
• Primary Completion: December 31, 2021
• Study Completion: July 7, 2022
• Last Updated: July 22, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)