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NCT Number: NCT03811366

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

Patients with acute onset Vogt-Koyanagi-Harada disease (VKHD) were 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.

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Key information

Conditions

Uveomeningoencephalitic Syndrome Autoimmune Diseases Autoimmune Diseases of the Nervous System Choroid Disease Choroid Diseases Eye Diseases Immune System Diseases Inflammation Nervous System Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Uveal Diseases Uveitis Vision Disorders Visual Impairment

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clinicas HCFMUSP, Faculdade de Medicina Universidade de Sao Paulo

São Paulo, 05403-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinical diagnosis of Vogt-Koyanagi-Harada disease
  • acute onset with no previous treatment

Exclusion criteria

  • non-acute VKHD
  • media opacities

Treatment and study plan

Corticosteroid monotherapy

Drug

Patients will receive corticosteroid monotherapy as a pulsetherapy (1000mg/ day for 3 days) followed by oral corticosteroid.

Other names: Prednisone arm, Corticosteroid pulsetherapy arm, Methilprednisolone arm

Primary outcomes

  1. Median Values of ERG Scotopic Parameters at 12-month

    Time frame: assessed at 12-month

    Full-field electroretinogram (ERG) scotopic parameters were evaluated at 12 -month (scotopic parameters: amplitude of scotopic a and b wave, amplitude of maximum scotopic a and b wave, oscillatory potential).

  2. Median Values of ERG Scotopic Parameters at 24-month

    Time frame: assessed at 24-month

    Full-field electroretinogram (ERG) scotopic parameters were evaluated at 24 -month (scotopic parameters: amplitude of scotopic a and b wave, amplitude of maximum scotopic a and b wave, oscillatory potential).

  3. Variation (Worsening or Improvement) Between 24 and 12 Months of ERG Scotopic Parameters Comparing 24 and 12-months

    Time frame: 12 and 24-months

    Full-field electroretinogram (ERG) scotopic parameters at 12 and 24 months were compared (scotopic parameters: amplitude of scotopic a and b wave, amplitude of maximum scotopic a and b wave, oscillatory potential). The worsening of the ERG parameters was defined as a value reduction of ≥ 30 % in any these scotopic ERG parameters at month 12 and month 24. We report the change between the (value at month 24/ the value at month 12)*100.

Secondary outcomes

  1. Recurrence or Worsening of Cells in Anterior Chamber

    Time frame: 6 to 24 months from disease onset.

    Evaluation of anterior chamber (AC) cells was performed at visits 6 months, 12 months, 18 months and 24 months from disease onset, according to the Standardization of Uveitis Nomenclature´s classification of anterior chamber cells. (Am J Ophthalmol, 2005) Any step increase (fluctuation), when comparing sequential dates of follow up (e.g 6 and 12 months) were considered as one episode of clinical worsening in AC cells

  2. Increase in the Score of Dark Dots on Indocyanine Green Angiography

    Time frame: 6 to 24 months from disease onset

    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) Dark dots Score based on pattern of distribution (Sparse/ Numerous) Minimum: 0 (better outcome) Maximum: 8 (worse outcome)

  3. Change in Subfoveal Choroidal Thickness on Enhanced Depth Optical Coherence Tomography

    Time frame: 6 to 24 months from disease onset

    Increase of 30% or more in choroidal thickness EDI in consecutive exams on horizontal scan

  4. Change in Perivascular Leakage on Fluorescein Angiography

    Time frame: 6 to 24 months after disease onset

    Perivascular leakage was observed as an increase in hyperfluorescence around retinal vasculature over time on FA exam at midperiphery.

  5. Choroidal Neovascularization

    Time frame: 6 to 24 months after disease onset

    Choroidal neovascularization was diagnosed when increasingly localized hyperfluorescence at the posterior pole is detected on FA or a hyperreflective subretinal lesion associated with sub or intraretinal fluid on OCT.

  6. Cataract

    Time frame: 6 to 24 months after disease onset

    Cataract was defined as any lens opacification greater than nuclear or cortical 2+/4 or subcapsular 1+/4

  7. Ocular Hypertension

    Time frame: 6 to 24 months after disease onset

    Ocular hypertension was defined as an intraocular pressure (IOP) above 21mmHg

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jan 22, 2019
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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