Early Immunosuppressive Therapy on the Course of Vogt-Koyanagi-Harada Disease

NCT03399175 | Recruiting

• 1 other identifier: VKH Brazilian Study Group
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vogt Koyanagi Harada Disease

Keywords

Vogt-Koyanagi-Harada disease; Immunosuppressive therapy; Indocyanine green angiography; Enhanced depth imaging optical coherence tomography; Electroretinogram

Outcome Measures

Primary Outcomes (1)

• scotopic electroretinogram results

  scotopic results variation between 12 months and 6 months

  6 month; 12 month

Secondary Outcomes (7)

• 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.

Study Arms (1)

Treatment group

OTHER

Early high-dose corticosteroid and immunosuppressive therapy

Drug: Early high-dose corticosteroid and immunosuppressive therapy

Interventions

Early high-dose corticosteroid and immunosuppressive therapy DRUG

Early high-dose corticosteroid and immunosuppressive therapy

Also known as: Treatment group

Treatment group

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- acute Vogt-Koyanagi-Harada disease

You may not qualify if:

• non collaborative patient
• minimum one-year follow-up

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

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

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

Related Publications (11)

• 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.

  PMID: 27008848 RESULT

• 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.

  PMID: 24440284 RESULT

• 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.

  PMID: 19668980 RESULT

• 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.

  PMID: 18992868 RESULT

• 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.

  PMID: 19781687 RESULT

• 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.

  PMID: 22889440 RESULT

• 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.

  PMID: 23099292 RESULT

• 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.

  PMID: 24548697 RESULT

• 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.

  PMID: 25592477 RESULT

• 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.

  PMID: 27368955 RESULT

• 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.

  PMID: 27844182 RESULT

MeSH Terms

Conditions

Uveomeningoencephalitic Syndrome

Interventions

Adrenal Cortex Hormones; Immunosuppression Therapy

Condition Hierarchy (Ancestors)

Autoimmune Diseases of the Nervous System; Nervous System Diseases; Uveitis; Uveal Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Joyce H Yamamoto, MD

  University of Sao Paulo School of Medicine Ophthalmology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joyce H Yamamoto, MD

CONTACT

55-11-99266-6474; joycehy@uol.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Early systemic high-dose corticosteroid and immunosuppressive therapy

Study Record Dates

• First Submitted: November 26, 2017
• First Posted: January 16, 2018
• Study Start: March 23, 2015
• Primary Completion: May 18, 2023
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)