Multimodal Analysis and Electroretinogram in VKH From Acute Onset - Part I

Study Overview
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Brief Summary
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Patients with acute onset Vogt-Koyanagi-Harada disease (VKHD) was prospectively included in this study. They were systematically followed with clinical, posterior segment imaging exams and full-field electroretinogram during a minimum 24-month of follow-up. All patients were treated with 3-day methylprednisolone pulse therapy followed by 1mg/day oral prednisone with a slow tapper during a median of 13 months. Non-steroidal immunosuppressive therapy (IMT) was introduced in cases of refractory disease or in cases of prednisone intolerance. Outcome measured by full-field electroretinogram was analyzed and patient was grouped as electroretinogram stable or electroretinogram worsening. Clinical data was analyzed in these two electroretinogram-based groups.

Detailed Description
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Consecutive patients with acute onset VKHD were included and followed for a minimum 24-month as Part I of an ongoing prospective long-term study on VKHD. The main purpose was to understand the course of clinical and subclinical choroidal inflammation in patients receiving early and high-dose corticosteroid followed by high-dose oral prednisone and a very slow tapper. All patients were followed with clinical and posterior segment imaging (PSI) exams, i.e. fundus picture, fluorescein angiography, indocyanine green angiography and enhanced depth imaging optical coherence tomography, at inclusion, 1st month, and thereof every three months. Full-field electroretinogram was performed at inclusion, 1st month, and thereof every six months. Flare was defined as appearance or increase/worsening of inflammatory signs after the initial six-month from disease onset during the predefined treatment protocol. Inflammatory signs were cells in anterior chamber, macular edema; subclinical inflammatory signs were mainly those observed by PSI exams. Scotopic full-field electroretinogram results between 12 and 24 month were the main outcome. Clinical data was analyzed in the full-field electroretinogram-based groups.

Official Title
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Multimodal Analysis and Electroretinogram in VKH From Acute Onset - a Prospective Study

Conditions
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Uveomeningoencephalitic Syndrome, Inflammation, Choroid Disease, Visual Impairment

Intervention / Treatment
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* Drug: Meticorten


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of Vogt-Koyanagi-Harada disease acute onset with no previous treatment Exclusion Criteria: non-acute VKHD media opacities
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: All patients were treated with a standard high-dose corticosteroid
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Meticorten|All patients were treated with 3-day methylprednisolone pulse therapy followed by 1mg/day oral prednisone with slow tapper over a median 13 months|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of eyes with changes in full-field scotopic electroretinogram results | variation >= 30% in the results between 12 and 24 months will define stable or worsening group | at inclusion, 1 month, 6 month, 12 month, 18 month and 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence or worsening of cells in anterior chamber | Standardization Uveitis Nomenclature´s classification of anterior chamber cells, any step increase will be considered (Am J Ophthalmo, 2005) | 0, 30 days, 3 months, 6 months, 12 months, 18 months and 24 months from disease onset. | 
| increase in the score of dark dots on indocyanine green angiography | dark dots scores had a maximum value of 8, any increase of 0.5 after 6 months from disease onset will be considered (Int Ophthalmo 2010) | 0, 30 days, 3 months, 6 months, 12 months, 18 months and 24 months from disease onset. | 
| change in subfoveal choroidal thickness on enhanced depth optical coherence tomography | increase of 30% or more in consecutive exams on horizontal scan after 6months from disease onset | 0, 30 days, 3 months, 6 months, 12 months from disease onset. | 
| change in optic disk hyperfluorescence on fluorescein angiography | appearance or worsening of optic disk hyperfluorescence in consecutive exams after 6months from disease onset | 0, 30 days, 3 months, 6 months, 12 months from disease onset. | 
| change in perivascular leakage on fluorescein angiography | perivascular leakage appearance or worsening after 6months from disease onset | 0, 30 days, 3 months, 6 months, 12 months from disease onset. |