Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT03811366
Recruitment Status : Completed
First Posted : January 22, 2019
Last Update Posted : January 22, 2019
Sponsor:
Information provided by (Responsible Party):
Joyce Hisae Yamamoto, University of Sao Paulo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Uveomeningoencephalitic Syndrome Inflammation Choroid Disease Visual Impairment Drug: Meticorten Not Applicable

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All patients were treated with a standard high-dose corticosteroid
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Multimodal Analysis and Electroretinogram in VKH From Acute Onset - a Prospective Study
Actual Study Start Date : June 1, 2011
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : January 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
Drug Information available for: Prednisone


Intervention Details:
  • 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


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


Secondary Outcome Measures :
  1. recurrence or worsening of cells in anterior chamber [ Time Frame: 0, 30 days, 3 months, 6 months, 12 months, 18 months and 24 months from disease onset. ]
    Standardization Uveitis Nomenclature´s classification of anterior chamber cells, any step increase will be considered (Am J Ophthalmo, 2005)

  2. increase in the score of dark dots on indocyanine green angiography [ Time Frame: 0, 30 days, 3 months, 6 months, 12 months, 18 months and 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)

  3. change in subfoveal choroidal thickness on enhanced depth optical coherence tomography [ Time Frame: 0, 30 days, 3 months, 6 months, 12 months from disease onset. ]
    increase of 30% or more in consecutive exams on horizontal scan after 6months from disease onset

  4. change in optic disk hyperfluorescence on fluorescein angiography [ Time Frame: 0, 30 days, 3 months, 6 months, 12 months from disease onset. ]
    appearance or worsening of optic disk hyperfluorescence in consecutive exams after 6months from disease onset

  5. change in perivascular leakage on fluorescein angiography [ Time Frame: 0, 30 days, 3 months, 6 months, 12 months from disease onset. ]
    perivascular leakage appearance or worsening after 6months from disease onset



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • non-acute VKHD
  • media opacities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811366


Locations
Layout table for location information
Brazil
Hospital das Clinicas HCFMUSP, Faculdade de Medicina Universidade de Sao Paulo
São Paulo, SP, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo
Publications:

Layout table for additonal information
Responsible Party: Joyce Hisae Yamamoto, Clinical Professor, person-in-charge of Uveitis Service, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03811366    
Other Study ID Numbers: Brazilian VKH Study Group I
First Posted: January 22, 2019    Key Record Dates
Last Update Posted: January 22, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Vision Disorders
Vision, Low
Uveomeningoencephalitic Syndrome
Choroid Diseases
Inflammation
Pathologic Processes
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Uveal Diseases
Autoimmune Diseases of the Nervous System
Uveitis
Autoimmune Diseases
Immune System Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents