Early Immunosuppressive Therapy on the Course of Vogt-Koyanagi-Harada Disease
ConditionVogt Koyanagi Harada Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-70
SponsorUniversity of Sao Paulo
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
non collaborative patient
minimum one-year follow-up
Trial design
Design model
Single group
Treatments tested in this trial
Early high-dose corticosteroid and immunosuppressive therapy
DrugEarly high-dose corticosteroid and immunosuppressive therapy
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Treatment groupOther 1 intervention
Trial outcomes
Primary outcomes
1
scotopic electroretinogram results
scotopic results variation between 12 months and 6 months
Time frame
6 month; 12 monthSecondary outcomes
1
presence of optic disc hyperfluorescence detected on fluorescein angiography
presence of optic disc hyperfluorescence and variation in intensity in consecutive examinations
Time frame
between 6 and 12 months from disease onset.2
presence of perivascular leakage on fluorescein angiography
presence of perivascular leakage and variation in extension and intensity in consecutive examinations
Time frame
between 6 and 12 months from disease onset.3
presence of dark dots on indocyanine green angiography
dark dots score and its fluctuation
Time frame
between 6 and 12 months from disease onset.4
subfoveal choroidal thickness on enhanced depth imaging optical coherence tomography
subfoveal choroidal thickness and its variation
Time frame
between 6 and 12 months from disease onset.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Sao Paulo
Lead sponsor
Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborator
Source ClinicalTrials.gov