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

May 18, 2023 updated by: Joyce Hisae Yamamoto, University of Sao Paulo

Influência de imunomodulação Precoce Influence of Early Immunosuppressive Therapy on the Course of Vogt-Koyanagi-Harada Disease: a Prospective Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05403-000
        • Recruiting
        • Hospital das Clinicas HCFMUSP, Faculdade de Medicina Universidade de Sao Paulo
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

- acute Vogt-Koyanagi-Harada disease

Exclusion criteria:

  • non collaborative patient
  • minimum one-year follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Treatment group
Early high-dose corticosteroid and immunosuppressive therapy
Drug: Early high-dose corticosteroid and immunosuppressive therapy
Early high-dose corticosteroid and immunosuppressive therapy
Other Names:
  • Treatment group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
scotopic electroretinogram results
Time Frame: 6 month; 12 month
scotopic results variation between 12 months and 6 months
6 month; 12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
between 6 and 12 months from disease onset.
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
between 6 and 12 months from disease onset.
presence of dark dots on indocyanine green angiography
Time Frame: between 6 and 12 months from disease onset.
dark dots score and its fluctuation
between 6 and 12 months from disease onset.
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
between 6 and 12 months from disease onset.
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
between 6 and 12 months from disease onset.
presence of choroidal neovascular membrane on OCT and/or FA
Time Frame: between 6 and 12 months from disease onset.
choroidal neovascular membrane
between 6 and 12 months from disease onset.
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
between 6 and 12 months from disease onset.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Joyce H Yamamoto, MD, University of Sao Paulo School of Medicine Ophthalmology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2015

Primary Completion (Actual)

May 18, 2023

Study Completion (Anticipated)

February 1, 2025

Study Registration Dates

First Submitted

November 26, 2017

First Submitted That Met QC Criteria

January 11, 2018

First Posted (Actual)

January 16, 2018

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VKH Brazilian Study Group

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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