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Multimodal Analysis and Electroretinogram in VKH From Acute Onset - Part I

Primary Purpose

Uveomeningoencephalitic Syndrome, Inflammation, Choroid Disease

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Meticorten

About this trial

This is an interventional other trial for Uveomeningoencephalitic Syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

clinical diagnosis of Vogt-Koyanagi-Harada disease
acute onset with no previous treatment

Exclusion Criteria:

non-acute VKHD
media opacities

Sites / Locations

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

Outcomes

Primary Outcome Measures

number of eyes with changes in full-field scotopic electroretinogram results

variation >= 30% in the results between 12 and 24 months will define stable or worsening group

Secondary Outcome Measures

recurrence or worsening of cells in anterior chamber

Standardization Uveitis Nomenclature´s classification of anterior chamber cells, any step increase will be considered (Am J Ophthalmo, 2005)

increase in the score of dark dots on indocyanine green angiography

dark dots scores had a maximum value of 8, any increase of 0.5 after 6 months from disease onset will be considered (Int Ophthalmo 2010)

change in subfoveal choroidal thickness on enhanced depth optical coherence tomography

increase of 30% or more in consecutive exams on horizontal scan after 6months from disease onset

change in optic disk hyperfluorescence on fluorescein angiography

appearance or worsening of optic disk hyperfluorescence in consecutive exams after 6months from disease onset

change in perivascular leakage on fluorescein angiography

perivascular leakage appearance or worsening after 6months from disease onset

Full Information

NCT ID

NCT03811366

First Posted

January 10, 2019

Last Updated

January 17, 2019

Sponsor

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT03811366

Brief Title

Multimodal Analysis and Electroretinogram in VKH From Acute Onset - Part I

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

June 1, 2011 (Actual)

Primary Completion Date

January 31, 2017 (Actual)

Study Completion Date

January 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uveomeningoencephalitic Syndrome, Inflammation, Choroid Disease, Visual Impairment

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

All patients were treated with a standard high-dose corticosteroid

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Meticorten

Intervention Description

All patients were treated with 3-day methylprednisolone pulse therapy followed by 1mg/day oral prednisone with slow tapper over a median 13 months

Primary Outcome Measure Information:

Title

number of eyes with changes in full-field scotopic electroretinogram results

Description

variation >= 30% in the results between 12 and 24 months will define stable or worsening group

Time Frame

at inclusion, 1 month, 6 month, 12 month, 18 month and 24 month

Secondary Outcome Measure Information:

Title

recurrence or worsening of cells in anterior chamber

Description

Standardization Uveitis Nomenclature´s classification of anterior chamber cells, any step increase will be considered (Am J Ophthalmo, 2005)

Time Frame

0, 30 days, 3 months, 6 months, 12 months, 18 months and 24 months from disease onset.

Title

increase in the score of dark dots on indocyanine green angiography

Description

dark dots scores had a maximum value of 8, any increase of 0.5 after 6 months from disease onset will be considered (Int Ophthalmo 2010)

Time Frame

0, 30 days, 3 months, 6 months, 12 months, 18 months and 24 months from disease onset.

Title

change in subfoveal choroidal thickness on enhanced depth optical coherence tomography

Description

increase of 30% or more in consecutive exams on horizontal scan after 6months from disease onset

Time Frame

0, 30 days, 3 months, 6 months, 12 months from disease onset.

Title

change in optic disk hyperfluorescence on fluorescein angiography

Description

appearance or worsening of optic disk hyperfluorescence in consecutive exams after 6months from disease onset

Time Frame

0, 30 days, 3 months, 6 months, 12 months from disease onset.

Title

change in perivascular leakage on fluorescein angiography

Description

perivascular leakage appearance or worsening after 6months from disease onset

Time Frame

0, 30 days, 3 months, 6 months, 12 months from disease onset.

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: clinical diagnosis of Vogt-Koyanagi-Harada disease acute onset with no previous treatment Exclusion Criteria: non-acute VKHD media opacities

Facility Information:

Facility Name

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

City

São Paulo

State/Province

ZIP/Postal Code

05403-000

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

26875727

Citation

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Citation

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Citation

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Multimodal Analysis and Electroretinogram in VKH From Acute Onset - Part I

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