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Early Immunosuppressive Therapy on the Course of Vogt-Koyanagi-Harada Disease

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03399175
Recruitment Status : Unknown
Verified January 2018 by Joyce Hisae Yamamoto, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : January 16, 2018
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Joyce Hisae Yamamoto, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE November 26, 2017
First Posted Date  ICMJE January 16, 2018
Last Update Posted Date January 17, 2018
Actual Study Start Date  ICMJE March 23, 2015
Estimated Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
scotopic electroretinogram results [ Time Frame: 6 month; 12 month ]
scotopic results variation between 12 months and 6 months
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2018)
  • presence of optic disc hyperfluorescence detected on fluorescein angiography [ Time Frame: between 6 and 12 months from disease onset. ]
    presence of optic disc hyperfluorescence and variation in intensity in consecutive examinations
  • presence of perivascular leakage on fluorescein angiography [ Time Frame: between 6 and 12 months from disease onset. ]
    presence of perivascular leakage and variation in extension and intensity in consecutive examinations
  • presence of dark dots on indocyanine green angiography [ Time Frame: between 6 and 12 months from disease onset. ]
    dark dots score and its fluctuation
  • subfoveal choroidal thickness on enhanced depth imaging optical coherence tomography [ Time Frame: between 6 and 12 months from disease onset. ]
    subfoveal choroidal thickness and its variation
  • presence of cells in anterior chamber graduated according to SUN criteria [ Time Frame: between 6 and 12 months from disease onset. ]
    presence of cells in anterior chamber and its variation
  • presence of choroidal neovascular membrane on OCT and/or FA [ Time Frame: between 6 and 12 months from disease onset. ]
    choroidal neovascular membrane
  • presence of macular edema on OCT and/or FA [ Time Frame: between 6 and 12 months from disease onset. ]
    macular edema detected clinically, angiographically and/or by optical coherence tomography
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
  • subclinical signs of inflammation on fluorescein angiography [ Time Frame: between 6 and 12 months from disease onset. ]
    presence of optic disc hyperfluorescence
  • subclinical signs of inflammation on fluorescein angiography [ Time Frame: between 6 and 12 months from disease onset. ]
    perivascular leakage
  • subclinical signs of inflammation on indocyanine green angiography [ Time Frame: between 6 and 12 months from disease onset. ]
    dark dots score and its fluctuation
  • subclinical signs of inflammation on enhanced depth imaging optical coherence tomography [ Time Frame: between 6 and 12 months from disease onset. ]
    subfoveal choroidal thickness and its variation
  • cells in anterior chamber [ Time Frame: between 6 and 12 months from disease onset. ]
    cells in anterior chamber
  • choroidal neovascular membrane [ Time Frame: between 6 and 12 months from disease onset. ]
    choroidal neovascular membrane
  • macular edema [ Time Frame: between 6 and 12 months from disease onset. ]
    macular edema detected clinically, angiographically and/or by optical coherence tomography
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Immunosuppressive Therapy on the Course of Vogt-Koyanagi-Harada Disease
Official Title  ICMJE Influência de imunomodulação Precoce Influence of Early Immunosuppressive Therapy on the Course of Vogt-Koyanagi-Harada Disease: a Prospective Study
Brief Summary This prospective study will include patients with Vogt-Koyanagi-Harada disease from disease onset, treated with early systemic high-dose corticosteroid and immunosuppressive therapy. Clinical and subclinical signs of disease activity added with electroretinogram exams, through predefined intervals, will be evaluated through a minimum 12-month follow-up.
Detailed Description

Vogt-Koyanagi-Harada disease (DVKH) is an autoimmune disorder, which is mainly a T CD4+ Th1 lymphocyte mediated aggression to melanocytes, in individuals with a genetic predisposition, in particular, the presence of HLA-DRB1*0405 allele. It is an important cause of non-infectious uveitis at tertiary services in Brazil and a major cause of uveitis in general, in some regions of the world, such as in Japan and Asia. Its clinical course is classically defined in four phases: prodromal, with general symptoms possibly related to a viral trigger; uveitic, with sudden decrease in visual acuity in both eyes with a diffuse choroiditis associated or not to iridocyclitis; convalescent, wherein the depigmentation of the integument and choroid is more evident, with an apparently quiescent disease from a clinical point of view; and chronic or recurrent, in which the predominant inflammatory signs of anterior segment are clinically detected and complications are more evident, such as choroidal neovascularization, cataract and glaucoma.

Recent studies have shown subclinical inflammation of the choroid, detected by indocyanine green angiography (ICGA) and also by enhanced-depth imaging spectral-domain optical coherence tomography (EDI-OCT). Several authors have been taking these findings into account for inflammation monitoring and treatment follow-up. However, the wider knowledge of these subclinical signs of inflammation and the understanding of the disease's course from a global perspective are still scarce. The study developed by Sakata et al. (2012-2015) established an early and aggressive treatment with pulsetherapy of methylprednisolone, followed by high doses of oral prednisone (1 mg / kg / day) with slow and gradual tapering over a 15-month period. Such study has showed that, despite an "adequate" treatment: a) 94% of patients had worsening of visual acuity or disease relapse during a 12-month follow-up; b) subclinical signs fluctuated without changing the initial treatment ; c) particular cases, in which there was an increase of treatment, showed better retinal function at final follow-up.

Thus, this study aims to continue the evaluation of subclinical signs and their clinical and functional relevance, as well as, with an early immunomodulatory treatment, to observe the clinical course of DVKH and its behavior in functional terms and development of complications. Study design: prospective and longitudinal, with a minimum 12-month follow-up, with integrated clinical, angiographic, tomographic and functional assessments. On clinical examination, anterior segment inflammatory signs will be evaluated (cells in anterior chamber), as well as posterior findings (observed in the acute phase: optic disc hyperemia, exudative retinal detachment, macular edema, vasculitis, vitreous haze); on angiographic evaluation, fluorescein angiogram (FA) and ICGA will be included; on tomographic evaluation, evaluation of retina and choroid will be included (EDI-OCT); and, on the functional tests, it will be included: the full-field electroretinography (ERGct) and multifocal electroretinography (ERGmf); as well as autofluorescence (AF) with blue light (Bl-AF) and near-infrared light (NIR-AF); automated perimetry (30-2) and contrast sensitivity test. Quality of life questionnaires and visual function evaluation will be included in pre-defined intervals.

Expected results: 1. To reaffirm the importance of an integrated analysis of the clinical and ancillary tests for better patient monitoring and to improve disease prognosis; 2. To increase the understanding of the disease natural course; 3. To increase the understanding of the disease pathogenesis; and, 4. To set parameters (outcomes) that can guide therapy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Early systemic high-dose corticosteroid and immunosuppressive therapy
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Vogt Koyanagi Harada Disease
Intervention  ICMJE Drug: Early high-dose corticosteroid and immunosuppressive therapy
Early high-dose corticosteroid and immunosuppressive therapy
Other Name: Treatment group
Study Arms  ICMJE Treatment group
Early high-dose corticosteroid and immunosuppressive therapy
Intervention: Drug: Early high-dose corticosteroid and immunosuppressive therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 11, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2019
Estimated Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Acute Vogt-Koyanagi-Harada disease

Exclusion Criteria:

  • non collaborative patient
  • minimum one-year follow-up
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03399175
Other Study ID Numbers  ICMJE VKH Brazilian Study Group
Has Data Monitoring Committee No
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  ICMJE
Plan to Share IPD: No
Responsible Party Joyce Hisae Yamamoto, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators  ICMJE
Principal Investigator: Joyce H Yamamoto, MD University of Sao Paulo School of Medicine Ophthalmology
PRS Account University of Sao Paulo
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP