Condition or disease | Intervention/treatment | Phase |
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Uveomeningoencephalitic Syndrome Inflammation Choroid Disease Visual Impairment | Drug: Meticorten | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | All patients were treated with a standard high-dose corticosteroid |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Multimodal Analysis and Electroretinogram in VKH From Acute Onset - a Prospective Study |
Actual Study Start Date : | June 1, 2011 |
Actual Primary Completion Date : | January 31, 2017 |
Actual Study Completion Date : | January 31, 2017 |
Tracking Information | |||||||
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First Submitted Date ICMJE | January 10, 2019 | ||||||
First Posted Date ICMJE | January 22, 2019 | ||||||
Last Update Posted Date | January 22, 2019 | ||||||
Actual Study Start Date ICMJE | June 1, 2011 | ||||||
Actual Primary Completion Date | January 31, 2017 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
number of eyes with changes in full-field scotopic electroretinogram results [ Time Frame: at inclusion, 1 month, 6 month, 12 month, 18 month and 24 month ] variation >= 30% in the results between 12 and 24 months will define stable or worsening group
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | No Changes Posted | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Multimodal Analysis and Electroretinogram in VKH From Acute Onset - Part I | ||||||
Official Title ICMJE | Multimodal Analysis and Electroretinogram in VKH From Acute Onset - a Prospective Study | ||||||
Brief Summary | Patients with acute onset Vogt-Koyanagi-Harada disease (VKHD) was 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. | ||||||
Detailed Description | Consecutive patients with acute onset VKHD were included and followed for a minimum 24-month as Part I of an ongoing prospective long-term study on VKHD. The main purpose was to understand the course of clinical and subclinical choroidal inflammation in patients receiving early and high-dose corticosteroid followed by high-dose oral prednisone and a very slow tapper. All patients were followed with clinical and posterior segment imaging (PSI) exams, i.e. fundus picture, fluorescein angiography, indocyanine green angiography and enhanced depth imaging optical coherence tomography, at inclusion, 1st month, and thereof every three months. Full-field electroretinogram was performed at inclusion, 1st month, and thereof every six months. Flare was defined as appearance or increase/worsening of inflammatory signs after the initial six-month from disease onset during the predefined treatment protocol. Inflammatory signs were cells in anterior chamber, macular edema; subclinical inflammatory signs were mainly those observed by PSI exams. Scotopic full-field electroretinogram results between 12 and 24 month were the main outcome. Clinical data was analyzed in the full-field electroretinogram-based groups. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: All patients were treated with a standard high-dose corticosteroid Masking: None (Open Label)Primary Purpose: Other |
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Condition ICMJE |
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Intervention ICMJE | Drug: Meticorten
All patients were treated with 3-day methylprednisolone pulse therapy followed by 1mg/day oral prednisone with slow tapper over a median 13 months
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Study Arms ICMJE | Not Provided | ||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
12 | ||||||
Original Actual Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | January 31, 2017 | ||||||
Actual Primary Completion Date | January 31, 2017 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | Child, Adult, Older Adult | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Brazil | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03811366 | ||||||
Other Study ID Numbers ICMJE | Brazilian VKH Study Group I | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Joyce Hisae Yamamoto, University of Sao Paulo | ||||||
Study Sponsor ICMJE | University of Sao Paulo | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | University of Sao Paulo | ||||||
Verification Date | January 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |