Working…
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

Tracking Information
First Submitted Date July 14, 2019
First Posted Date July 19, 2019
Last Update Posted Date July 22, 2019
Estimated Study Start Date July 20, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 16, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 16, 2019)
  • 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
  • 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
  • Use Maia perimeter to measure macular integrality [ Time Frame: one year ]
    Use Maia perimeter to measure macular integrality including light threshold and central fixation.
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Immune Profile of Acute VKH Patients PBMC
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.
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood sample of VKH patients
Sampling Method Non-Probability Sample
Study Population acute primary VKH patients
Condition VKH Syndrome
Intervention Drug: Steroids
IV and oral steroids
Study Groups/Cohorts
  • VKH patients
    acute VKH patients
    Intervention: Drug: Steroids
  • control
    health people age/sex match to the VKH patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 16, 2019)		 48
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 7, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
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
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04025476
Other Study ID Numbers AFM1713D1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Aier School of Ophthalmology, Central South University
Study Sponsor Aier School of Ophthalmology, Central South University
Collaborators Not Provided
Investigators
Study Director: Qing Zhang, MD Central-southern university, Aier ophthalmology colleage
PRS Account Aier School of Ophthalmology, Central South University
Verification Date July 2019