Influência de imunomodulação Precoce Influence of Early Immunosuppressive Therapy on the Course of Vogt-Koyanagi-Harada Disease: a Prospective Study
Sponsor study identifier
interventional
40
1 country
1
Study Start
March 23, 2015
Actual (reported)Primary Completion
May 18, 2023
Actual (reported)Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 23, 2015
Actual (reported)November 26, 2017
Actual (reported)January 16, 2018
Actual (reported)May 18, 2023
Actual (reported)December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
scotopic electroretinogram results
scotopic results variation between 12 months and 6 months
6 month; 12 month
presence of optic disc hyperfluorescence detected on fluorescein angiography
between 6 and 12 months from disease onset.
presence of perivascular leakage on fluorescein angiography
between 6 and 12 months from disease onset.
presence of dark dots on indocyanine green angiography
between 6 and 12 months from disease onset.
subfoveal choroidal thickness on enhanced depth imaging optical coherence tomography
between 6 and 12 months from disease onset.
presence of cells in anterior chamber graduated according to SUN criteria
between 6 and 12 months from disease onset.
Early high-dose corticosteroid and immunosuppressive therapy
Early high-dose corticosteroid and immunosuppressive therapy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospital das Clinicas HCFMUSP, Faculdade de Medicina Universidade de Sao Paulo
São Paulo, São Paulo, 05403-000, Brazil
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.
Sakata VM, da Silva FT, Hirata CE, de Carvalho JF, Yamamoto JH. Diagnosis and classification of Vogt-Koyanagi-Harada disease. Autoimmun Rev. 2014 Apr-May;13(4-5):550-5. doi: 10.1016/j.autrev.2014.01.023. Epub 2014 Jan 15.
Joyce H Yamamoto, MD
University of Sao Paulo School of Medicine Ophthalmology
First Submitted
November 26, 2017
First Posted
January 16, 2018
Study Start
March 23, 2015
Actual (reported)Primary Completion
A Study of Adalimumab in Acute Vogt-Koyanagi-Harada Disease
Contact the study team to confirm eligibility.
Damico FM, Bezerra FT, Silva GC, Gasparin F, Yamamoto JH. New insights into Vogt-Koyanagi-Harada disease. Arq Bras Oftalmol. 2009 May-Jun;72(3):413-20. doi: 10.1590/s0004-27492009000300028.
da Silva FT, Damico FM, Marin ML, Goldberg AC, Hirata CE, Takiuti PH, Olivalves E, Yamamoto JH. Revised diagnostic criteria for vogt-koyanagi-harada disease: considerations on the different disease categories. Am J Ophthalmol. 2009 Feb;147(2):339-345.e5. doi: 10.1016/j.ajo.2008.08.034. Epub 2008 Nov 7.
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.
da Silva FT, Hirata CE, Sakata VM, Olivalves E, Preti R, Pimentel SL, Gomes A, Takahashi WY, Costa RA, Yamamoto JH. Indocyanine green angiography findings in patients with long-standing Vogt-Koyanagi-Harada disease: a cross-sectional study. BMC Ophthalmol. 2012 Aug 13;12:40. doi: 10.1186/1471-2415-12-40.
da Silva FT, Sakata VM, Nakashima A, Hirata CE, Olivalves E, Takahashi WY, Costa RA, Yamamoto JH. Enhanced depth imaging optical coherence tomography in long-standing Vogt-Koyanagi-Harada disease. Br J Ophthalmol. 2013 Jan;97(1):70-4. doi: 10.1136/bjophthalmol-2012-302089. Epub 2012 Oct 25.
Sakata VM, da Silva FT, Hirata CE, Takahashi WY, Costa RA, Yamamoto JH. Choroidal bulging in patients with Vogt-Koyanagi-Harada disease in the non-acute uveitic stage. J Ophthalmic Inflamm Infect. 2014 Feb 18;4(1):6. doi: 10.1186/1869-5760-4-6.
Sakata VM, da Silva FT, Hirata CE, Marin ML, Rodrigues H, Kalil J, Costa RA, Yamamoto JH. High rate of clinical recurrence in patients with Vogt-Koyanagi-Harada disease treated with early high-dose corticosteroids. Graefes Arch Clin Exp Ophthalmol. 2015 May;253(5):785-90. doi: 10.1007/s00417-014-2904-z. Epub 2015 Jan 16.
Morita C, Sakata VM, Rodriguez EE, Abdallah SF, Lavezzo MM, da Silva FT, Machado CG, Oyamada MK, Hirata CE, Yamamoto JH. Fundus autofluorescence as a marker of disease severity in Vogt-Koyanagi-Harada disease. Acta Ophthalmol. 2016 Dec;94(8):e820-e821. doi: 10.1111/aos.13147. Epub 2016 Jul 2. No abstract available.
Herbort CP Jr, Abu El Asrar AM, Yamamoto JH, Pavesio 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.
May 18, 2023
Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 7, 2026
Record last verified: 2026-05
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