Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Immune Profile of Acute VKH Patients PBMC (IPV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04025476
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
Aier School of Ophthalmology, Central South University

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.

Condition or disease Intervention/treatment
VKH Syndrome Drug: Steroids

Layout table for study information
Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Case-Control
Time Perspective: Prospective
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.
Estimated Study Start Date : July 20, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : July 7, 2022

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. choroid and retinal thickness change in different course of VKH patients [ Time Frame: one year ]
    Use OCT(optical coherence tomography) to measure choroid and retina thickness changes in macular zone of different course VKH patients

  2. Use OCTA(optical coherence tomography angiography) to measure macular and optic disc vascular index [ Time Frame: one year ]
    Use OCTA to measure macular and optic disc vascular index in different course VKH patients

  3. Use Maia perimeter to measure macular integrality [ Time Frame: one year ]
    Use Maia perimeter to measure macular integrality including light threshold and central fixation.

  4. measure the Injury degree of choroid and retinal vessels [ Time Frame: one year ]
    Use FFA(fluorescein fundus angiography)/ICG(Indocyanine Green Angiography) to measure the Injury degree of choroid and retinal vessels


Biospecimen Retention:   Samples With DNA
blood sample of VKH patients


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
acute primary VKH patients
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04025476


Contacts
Layout table for location contacts
Contact: Zhaohui Li, Ph.D/MD +86-186-2790-1441 lizhaohui@whu.edu.cn
Contact: Yafei Huang, Ph.d +86-136-2862-7928 huangyf@tjh.tjmu.edu.cn

Locations
Layout table for location information
China, Hubei
Wuhan Aier eye hospital Recruiting
Wuhan, Hubei, China, 430064
Contact: Zhaohui Li, Ph.D/MD    +86-186-2790-1441    lizhaohui@whu.edu.cn   
Contact: Yafei Huang, Ph.D    +86-136-28627928    huangyf@tjh.tjmu.edu.cn   
Sponsors and Collaborators
Aier School of Ophthalmology, Central South University
Investigators
Layout table for investigator information
Study Director: Qing Zhang, MD Central-southern university, Aier ophthalmology colleage
Layout table for additonal information
Responsible Party: Aier School of Ophthalmology, Central South University
ClinicalTrials.gov Identifier: NCT04025476    
Other Study ID Numbers: AFM1713D1
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aier School of Ophthalmology, Central South University:
VKH; immune profile;
Additional relevant MeSH terms:
Layout table for MeSH terms
Uveomeningoencephalitic Syndrome
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Uveitis
Uveal Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases