Vogt Koyanagi Harada DiseaseNCT03399175
Early Immunosuppressive Therapy on the Course of Vogt-Koyanagi-Harada Disease
A study testing Early high-dose corticosteroid and immunosuppressive therapy in people with Vogt Koyanagi Harada Disease, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Vogt Koyanagi Harada Disease
- What is being tested?
- Early high-dose corticosteroid and immunosuppressive therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Mar 2015to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- acute Vogt-Koyanagi-Harada disease
Who cannot join
- non collaborative patient
- minimum one-year follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clinicas HCFMUSP, Faculdade de Medicina Universidade de Sao Paulo
São Paulo, São Paulo, 05403-000
Joyce Yamamoto, MD, 11992666474, joycehy@uol.com.br
Marcelo M Lavezzo, MD, mmlavezzo@gmail.com
About this study
Official title: Influência de imunomodulação Precoce Influence of Early Immunosuppressive Therapy on the Course of Vogt-Koyanagi-Harada Disease: a Prospective Study
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.
Read the detailed description
Vogt-Koyanagi-Harada disease (DVKH) is an autoimmune disorder, which is mainly a T CD4+ Th1 lymphocyte mediated aggression to melanocytes, in individuals with a genetic predisposition, in particular, the presence of HLA-DRB1*0405 allele. It is an important cause of non-infectious uveitis at tertiary services in Brazil and a major cause of uveitis in general, in some regions of the world, such as in Japan and Asia. Its clinical course is classically defined in four phases: prodromal, with general symptoms possibly related to a viral trigger; uveitic, with sudden decrease in visual acuity in both eyes with a diffuse choroiditis associated or not to iridocyclitis; convalescent, wherein the depigmentation of the integument and choroid is more evident, with an apparently quiescent disease from a clinical point of view; and chronic or recurrent, in which the predominant inflammatory signs of anterior segment are clinically detected and complications are more evident, such as choroidal neovascularization, cataract and glaucoma.
Recent studies have shown subclinical inflammation of the choroid, detected by indocyanine green angiography (ICGA) and also by enhanced-depth imaging spectral-domain optical coherence tomography (EDI-OCT). Several authors have been taking these findings into account for inflammation monitoring and treatment follow-up. However, the wider knowledge of these subclinical signs of inflammation and the understanding of the disease's course from a global perspective are still scarce. The study developed by Sakata et al. (2012-2015) established an early and aggressive treatment with pulsetherapy of methylprednisolone, followed by high doses of oral prednisone (1 mg / kg / day) with slow and gradual tapering over a 15-month period. Such study has showed that, despite an "adequate" treatment: a) 94% of patients had worsening of visual acuity or disease relapse during a 12-month follow-up; b) subclinical signs fluctuated without changing the initial treatment ; c) particular cases, in which there was an increase of treatment, showed better retinal function at final follow-up.
Thus, this study aims to continue the evaluation of subclinical signs and their clinical and functional relevance, as well as, with an early immunomodulatory treatment, to observe the clinical course of DVKH and its behavior in functional terms and development of complications. Study design: prospective and longitudinal, with a minimum 12-month follow-up, with integrated clinical, angiographic, tomographic and functional assessments. On clinical examination, anterior segment inflammatory signs will be evaluated (cells in anterior chamber), as well as posterior findings (observed in the acute phase: optic disc hyperemia, exudative retinal detachment, macular edema, vasculitis, vitreous haze); on angiographic evaluation, fluorescein angiogram (FA) and ICGA will be included; on tomographic evaluation, evaluation of retina and choroid will be included (EDI-OCT); and, on the functional tests, it will be included: the full-field electroretinography (ERGct) and multifocal electroretinography (ERGmf); as well as autofluorescence (AF) with blue light (Bl-AF) and near-infrared light (NIR-AF); automated perimetry (30-2) and contrast sensitivity test. Quality of life questionnaires and visual function evaluation will be included in pre-defined intervals.
Expected results: 1. To reaffirm the importance of an integrated analysis of the clinical and ancillary tests for better patient monitoring and to improve disease prognosis; 2. To increase the understanding of the disease natural course; 3. To increase the understanding of the disease pathogenesis; and, 4. To set parameters (outcomes) that can guide therapy.
- Conditions
- Vogt Koyanagi Harada Disease
- Being tested
- Early high-dose corticosteroid and immunosuppressive therapy
- Keywords
- Vogt-Koyanagi-Harada disease, Immunosuppressive therapy, Indocyanine green angiography, Enhanced depth imaging optical coherence tomography, Electroretinogram
- Medical subject headings
- Uveomeningoencephalitic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early high-dose corticosteroid and immunosuppressive therapyDrug
Also called Treatment group
Early high-dose corticosteroid and immunosuppressive therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Other | Early high-dose corticosteroid and immunosuppressive therapy Receives: Drug: Early high-dose corticosteroid and immunosuppressive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
scotopic electroretinogram results
scotopic results variation between 12 months and 6 months
Measured: 6 month; 12 month
Secondary outcomes (7)
presence of optic disc hyperfluorescence detected on fluorescein angiography
presence of optic disc hyperfluorescence and variation in intensity in consecutive examinations
Measured: between 6 and 12 months from disease onset.
presence of perivascular leakage on fluorescein angiography
presence of perivascular leakage and variation in extension and intensity in consecutive examinations
Measured: between 6 and 12 months from disease onset.
presence of dark dots on indocyanine green angiography
dark dots score and its fluctuation
Measured: between 6 and 12 months from disease onset.
subfoveal choroidal thickness on enhanced depth imaging optical coherence tomography
subfoveal choroidal thickness and its variation
Measured: between 6 and 12 months from disease onset.
presence of cells in anterior chamber graduated according to SUN criteria
presence of cells in anterior chamber and its variation
Measured: between 6 and 12 months from disease onset.
presence of choroidal neovascular membrane on OCT and/or FA
choroidal neovascular membrane
Measured: between 6 and 12 months from disease onset.
presence of macular edema on OCT and/or FA
macular edema detected clinically, angiographically and/or by optical coherence tomography
Measured: between 6 and 12 months from disease onset.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start23 Mar 2015
- Primary completion18 May 2023
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Vogt Koyanagi Harada DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Early systemic high-dose corticosteroid and immunosuppressive therapy
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Joyce Hisae Yamamoto, University of Sao Paulo
- Investigators
- Joyce H Yamamoto, MD, Principal investigator, University of Sao Paulo School of Medicine Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399175
- Sponsor's protocol ID
- VKH Brazilian Study Group
- Status last verified
- May 2026
- First submitted
- 26 Nov 2017
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27008848Sakata 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.
PubMed 24440284Damico 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.
PubMed 19668980da 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.
PubMed 18992868da 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.
PubMed 19781687da 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.
PubMed 22889440da 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.
PubMed 23099292Sakata 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.
PubMed 24548697Sakata 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.
PubMed 25592477Morita 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.
PubMed 27368955Herbort 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.
PubMed 27844182
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influência de imunomodulação Precoce Influence of Early Immunosuppressive Therapy on the Course of Vogt-Koyanagi-Harada Disease: a Prospective Study
- ClinicalTrials.gov ID
- NCT03399175
- Acronym / sponsor ID
- VKH Brazilian Study Group
- Conditions
- Vogt Koyanagi Harada Disease
- Keywords
- Vogt-Koyanagi-Harada disease, Immunosuppressive therapy, Indocyanine green angiography, Enhanced depth imaging optical coherence tomography, Electroretinogram
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 23 Mar 2015 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Vogt-Koyanagi-Harada disease (DVKH) is an autoimmune disorder, which is mainly a T CD4+ Th1 lymphocyte mediated aggression to melanocytes, in individuals with a genetic predisposition, in particular, the presence of HLA-DRB1*0405 allele. It is an important cause of non-infectious uveitis at tertiary services in Brazil and a major cause of uveitis in general, in some regions of the world, such as in Japan and Asia. Its clinical course is classically defined in four phases: prodromal, with general symptoms possibly related to a viral trigger; uveitic, with sudden decrease in visual acuity in both eyes with a diffuse choroiditis associated or not to iridocyclitis; convalescent, wherein the depigmentation of the integument and choroid is more evident, with an apparently quiescent disease from a clinical point of view; and chronic or recurrent, in which the predominant inflammatory signs of anterior segment are clinically detected and complications are more evident, such as choroidal neovascularization, cataract and glaucoma.
Recent studies have shown subclinical inflammation of the choroid, detected by indocyanine green angiography (ICGA) and also by enhanced-depth imaging spectral-domain optical coherence tomography (EDI-OCT). Several authors have been taking these findings into account for inflammation monitoring and treatment follow-up. However, the wider knowledge of these subclinical signs of inflammation and the understanding of the disease's course from a global perspective are still scarce. The study developed by Sakata et al. (2012-2015) established an early and aggressive treatment with pulsetherapy of methylprednisolone, followed by high doses of oral prednisone (1 mg / kg / day) with slow and gradual tapering over a 15-month period. Such study has showed that, despite an "adequate" treatment: a) 94% of patients had worsening of visual acuity or disease relapse during a 12-month follow-up; b) subclinical signs fluctuated without changing the initial treatment ; c) particular cases, in which there was an increase of treatment, showed better retinal function at final follow-up.
Thus, this study aims to continue the evaluation of subclinical signs and their clinical and functional relevance, as well as, with an early immunomodulatory treatment, to observe the clinical course of DVKH and its behavior in functional terms and development of complications. Study design: prospective and longitudinal, with a minimum 12-month follow-up, with integrated clinical, angiographic, tomographic and functional assessments. On clinical examination, anterior segment inflammatory signs will be evaluated (cells in anterior chamber), as well as posterior findings (observed in the acute phase: optic disc hyperemia, exudative retinal detachment, macular edema, vasculitis, vitreous haze); on angiographic evaluation, fluorescein angiogram (FA) and ICGA will be included; on tomographic evaluation, evaluation of retina and choroid will be included (EDI-OCT); and, on the functional tests, it will be included: the full-field electroretinography (ERGct) and multifocal electroretinography (ERGmf); as well as autofluorescence (AF) with blue light (Bl-AF) and near-infrared light (NIR-AF); automated perimetry (30-2) and contrast sensitivity test. Quality of life questionnaires and visual function evaluation will be included in pre-defined intervals.
Expected results: 1. To reaffirm the importance of an integrated analysis of the clinical and ancillary tests for better patient monitoring and to improve disease prognosis; 2. To increase the understanding of the disease natural course; 3. To increase the understanding of the disease pathogenesis; and, 4. To set parameters (outcomes) that can guide therapy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Early systemic high-dose corticosteroid and immunosuppressive therapy
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Other | Drug: Early high-dose corticosteroid and immunosuppressive therapyEarly high-dose corticosteroid and immunosuppressive therapy |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- acute Vogt-Koyanagi-Harada disease
Key exclusion criteria (2 listed)
- non collaborative patient
- minimum one-year follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early high-dose corticosteroid and immunosuppressive therapyAlso: Treatment groupEarly high-dose corticosteroid and immunosuppressive therapy | Drug | Treatment group |
Primary outcome
scotopic electroretinogram results
Time frame: 6 month; 12 month
scotopic results variation between 12 months and 6 months
7 secondary outcomes
presence of optic disc hyperfluorescence detected on fluorescein angiography
Time frame: between 6 and 12 months from disease onset.
presence of perivascular leakage on fluorescein angiography
Time frame: between 6 and 12 months from disease onset.
presence of dark dots on indocyanine green angiography
Time frame: between 6 and 12 months from disease onset.
subfoveal choroidal thickness on enhanced depth imaging optical coherence tomography
Time frame: between 6 and 12 months from disease onset.
presence of cells in anterior chamber graduated according to SUN criteria
Time frame: between 6 and 12 months from disease onset.
presence of choroidal neovascular membrane on OCT and/or FA
Time frame: between 6 and 12 months from disease onset.
presence of macular edema on OCT and/or FA
Time frame: between 6 and 12 months from disease onset.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Results publication: PubMed 27008848Lavezzo 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.
- Results publication: PubMed 24440284Sakata 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.
- Results publication: PubMed 19668980Damico 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.
- Results publication: PubMed 18992868da 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.
- Results publication: PubMed 19781687da 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.
- Results publication: PubMed 22889440da 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.
- Results publication: PubMed 23099292da 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.
- Results publication: PubMed 24548697Sakata 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.
- Results publication: PubMed 25592477Sakata 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.
- Results publication: PubMed 27368955Morita 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.
- Results publication: PubMed 27844182Herbort 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joyce H Yamamoto, MD principal investigator
University of Sao Paulo School of Medicine Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early high-dose corticosteroid and immunosuppressive therapy in people with Vogt Koyanagi Harada Disease, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joyce H Yamamoto, MD (55-11-99266-6474, joycehy@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scotopic electroretinogram results (time frame: 6 month; 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03399175, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.