CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Corticosteroid monotherapydrug
Likely dose
Corticosteroid monotherapy 1000mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03811366
NCT03811366N/ACompleted

Multimodal Analysis and Electroretinogram in VKH From Acute Onset - a Prospective Study

University of Sao Paulo·interventional·Posted Jan 22, 2019·Updated Apr 17, 2025

In Brief

A clinical study evaluating Corticosteroid monotherapy for Uveomeningoencephalitic Syndrome and 3 related conditions. Completed, enrolled 12 participants across 1 site.

Detailed Summary

Patients with acute onset Vogt-Koyanagi-Harada disease (VKHD) were 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 22, 2019
Enrollment StartJun 1, 2011
Primary CompletionJan 31, 2017
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 7.4 years ago

Interventions

Corticosteroid monotherapydrug

Patients will receive corticosteroid monotherapy as a pulsetherapy (1000mg/ day for 3 days) followed by oral corticosteroid.