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出境医 / 临床实验 / Multimodal Analysis and Electroretinogram in VKH From Acute Onset - Part I

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

Study Description
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.
Study Design
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
Arms and Interventions
Outcome Measures
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


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date  ICMJE January 10, 2019
First Posted Date  ICMJE January 22, 2019
Last Update Posted Date January 22, 2019
Actual Study Start Date  ICMJE June 1, 2011
Actual Primary Completion Date January 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • 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)
  • 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)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multimodal Analysis and Electroretinogram in VKH From Acute Onset - Part I
Official Title  ICMJE Multimodal Analysis and Electroretinogram in VKH From Acute Onset - a Prospective Study
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Uveomeningoencephalitic Syndrome
  • Inflammation
  • Choroid Disease
  • Visual Impairment
Intervention  ICMJE 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
Study Arms  ICMJE Not Provided
Publications *
  • Du L, Kijlstra A, Yang P. Vogt-Koyanagi-Harada disease: Novel insights into pathophysiology, diagnosis and treatment. Prog Retin Eye Res. 2016 May;52:84-111. doi: 10.1016/j.preteyeres.2016.02.002. Epub 2016 Feb 11. Review.
  • Lavezzo MM, Sakata VM, Morita C, Rodriguez EE, Abdallah SF, da Silva FT, Hirata CE, Yamamoto JH. Vogt-Koyanagi-Harada disease: review of a rare autoimmune disease targeting antigens of melanocytes. Orphanet J Rare Dis. 2016 Mar 24;11:29. doi: 10.1186/s13023-016-0412-4. Review.
  • Rao NA. Pathology of Vogt-Koyanagi-Harada disease. Int Ophthalmol. 2007 Apr-Jun;27(2-3):81-5. Epub 2007 Apr 14. Review.
  • Rubsamen PE, Gass JD. Vogt-Koyanagi-Harada syndrome. Clinical course, therapy, and long-term visual outcome. Arch Ophthalmol. 1991 May;109(5):682-7.
  • Herbort CP Jr, Abu El Asrar AM, Takeuchi M, Pavésio CE, Couto C, Hedayatfar A, Maruyama K, Rao X, Silpa-Archa S, Somkijrungroj T. Catching the therapeutic window of opportunity in early initial-onset Vogt-Koyanagi-Harada uveitis can cure the disease. Int Ophthalmol. 2019 Jun;39(6):1419-1425. doi: 10.1007/s10792-018-0949-4. Epub 2018 Jun 11. Review.
  • Yang P, Fang W, Wang L, Wen F, Wu W, Kijlstra A. Study of macular function by multifocal electroretinography in patients with Vogt-Koyanagi-Harada syndrome. Am J Ophthalmol. 2008 Nov;146(5):767-71. doi: 10.1016/j.ajo.2008.05.044. Epub 2008 Jul 30.
  • Chee SP, Jap A, Bacsal K. Spectrum of Vogt-Koyanagi-Harada disease in Singapore. Int Ophthalmol. 2007 Apr-Jun;27(2-3):137-42. Epub 2006 Nov 11.
  • Yuan W, Zhou C, Cao Q, Du Z, Hu R, Wang Y, Kijlstra A, Yang P. Longitudinal Study of Visual Function in Vogt-Koyanagi-Harada Disease Using Full-Field Electroretinography. Am J Ophthalmol. 2018 Jul;191:92-99. doi: 10.1016/j.ajo.2018.04.013. Epub 2018 Apr 25.
  • Chee SP, Luu CD, Cheng CL, Lim WK, Jap A. Visual function in Vogt-Koyanagi-Harada patients. Graefes Arch Clin Exp Ophthalmol. 2005 Aug;243(8):785-90. Epub 2005 Mar 11.
  • da Silva FT, Hirata CE, Olivalves E, Oyamada MK, Yamamoto JH. Fundus-based and electroretinographic strategies for stratification of late-stage Vogt-Koyanagi-Harada disease patients. Am J Ophthalmol. 2009 Dec;148(6):939-45.e3. doi: 10.1016/j.ajo.2009.06.029. Epub 2009 Sep 24.
  • Tugal-Tutkun I, Herbort CP, Khairallah M; Angiography Scoring for Uveitis Working Group (ASUWOG). Scoring of dual fluorescein and ICG inflammatory angiographic signs for the grading of posterior segment inflammation (dual fluorescein and ICG angiographic scoring system for uveitis). Int Ophthalmol. 2010 Oct;30(5):539-52. doi: 10.1007/s10792-008-9263-x. Epub 2008 Sep 16.
  • Nakayama M, Keino H, Watanabe T, Okada AA. Clinical features and visual outcomes of 111 patients with new-onset acute Vogt-Koyanagi-Harada disease treated with pulse intravenous corticosteroids. Br J Ophthalmol. 2019 Feb;103(2):274-278. doi: 10.1136/bjophthalmol-2017-311691. Epub 2018 Apr 17.
  • Kawaguchi T, Horie S, Bouchenaki N, Ohno-Matsui K, Mochizuki M, Herbort CP. Suboptimal therapy controls clinically apparent disease but not subclinical progression of Vogt-Koyanagi-Harada disease. Int Ophthalmol. 2010 Feb;30(1):41-50. doi: 10.1007/s10792-008-9288-1. Epub 2009 Jan 17.
  • Herbort CP Jr, Abu El Asrar AM, Yamamoto JH, Pavésio CE, Gupta V, Khairallah M, Tugal-Tutkun I, Soheilian M, Takeuchi M, Papadia M. Reappraisal of the management of Vogt-Koyanagi-Harada disease: sunset glow fundus is no more a fatality. Int Ophthalmol. 2017 Dec;37(6):1383-1395. doi: 10.1007/s10792-016-0395-0. Epub 2016 Nov 14. Review.
  • Abu El-Asrar AM, Dosari M, Hemachandran S, Gikandi PW, Al-Muammar A. Mycophenolate mofetil combined with systemic corticosteroids prevents progression to chronic recurrent inflammation and development of 'sunset glow fundus' in initial-onset acute uveitis associated with Vogt-Koyanagi-Harada disease. Acta Ophthalmol. 2017 Feb;95(1):85-90. doi: 10.1111/aos.13189. Epub 2016 Aug 18.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2019)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 31, 2017
Actual Primary Completion Date January 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • non-acute VKHD
  • media opacities
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 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 NCT03811366
Other Study ID Numbers  ICMJE Brazilian VKH Study Group I
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joyce Hisae Yamamoto, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Sao Paulo
Verification Date January 2019

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