An interventional study of Corticosteroid monotherapy in Uveomeningoencephalitic Syndrome, Inflammation and Choroid Disease, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2025-04-17.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Other
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.
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.
20 studies on the registry are indexed under Choroid Diseases; 7 are open to participants now.
This study's enrollment of 12 is below the median of 63 across 11 interventional studies indexed under Choroid Diseases.
Browse Choroid Diseases studies →University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Choroid Diseases, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Inflammation. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
All patients in the acute phase will be treated with corticosteroid monotherapy, unless presents a contraindication or persistence/ recurrence of inflammation with regressive corticosteroid monotherapy.This is the unique arm of the present study. Treatment protocol includes a three-day course of intravenous methylprednisolone (1000 mg per day) followed by a high dose of oral prednisone (1.0 mg/kg/day) with a slow tapering with dose equal or less than 0.1mg/kg/day after 10 months. The prednisone dose is scheduled to be reduced in a 0.1 mg/kg-step ladder until it reaches 0.3 mg/kg (i.e. for an individual with 60 kg, dose would be 20 mg): from 1 to 0.8 mg/kg every two to three weeks; at 0.7 mg/kg for 4 weeks; at 0.6 mg/kg for two to three weeks; from 0.5 mg/kg every 4 weeks; from 0.3 to 0.15 mg/kg every 6 weeks; and 0.1 mg/kg, 0.075 mg/kg and 0.05 mg/kg for 8 weeks each.
Drug: Corticosteroid monotherapy
Patients will receive corticosteroid monotherapy as a pulsetherapy (1000mg/ day for 3 days) followed by oral corticosteroid.
Also known as: Prednisone arm, Corticosteroid pulsetherapy arm, Methilprednisolone arm
Median Values of ERG Scotopic Parameters at 12-month
Full-field electroretinogram (ERG) scotopic parameters were evaluated at 12 -month (scotopic parameters: amplitude of scotopic a and b wave, amplitude of maximum scotopic a and b wave, oscillatory potential).
Time frame: assessed at 12-month
Median Values of ERG Scotopic Parameters at 24-month
Full-field electroretinogram (ERG) scotopic parameters were evaluated at 24 -month (scotopic parameters: amplitude of scotopic a and b wave, amplitude of maximum scotopic a and b wave, oscillatory potential).
Time frame: assessed at 24-month
Variation (Worsening or Improvement) Between 24 and 12 Months of ERG Scotopic Parameters Comparing 24 and 12-months
Full-field electroretinogram (ERG) scotopic parameters at 12 and 24 months were compared (scotopic parameters: amplitude of scotopic a and b wave, amplitude of maximum scotopic a and b wave, oscillatory potential). The worsening of the ERG parameters was defined as a value reduction of ≥ 30 % in any these scotopic ERG parameters at month 12 and month 24. We report the change between the (value at month 24/ the value at month 12)\*100.
Time frame: 12 and 24-months
Recurrence or Worsening of Cells in Anterior Chamber
Evaluation of anterior chamber (AC) cells was performed at visits 6 months, 12 months, 18 months and 24 months from disease onset, according to the Standardization of Uveitis Nomenclature´s classification of anterior chamber cells. (Am J Ophthalmol, 2005) Any step increase (fluctuation), when comparing sequential dates of follow up (e.g 6 and 12 months) were considered as one episode of clinical worsening in AC cells
Time frame: 6 to 24 months from disease onset.
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) Dark dots Score based on pattern of distribution (Sparse/ Numerous) Minimum: 0 (better outcome) Maximum: 8 (worse outcome)
Time frame: 6 to 24 months from disease onset
Change in Subfoveal Choroidal Thickness on Enhanced Depth Optical Coherence Tomography
Increase of 30% or more in choroidal thickness EDI in consecutive exams on horizontal scan
Time frame: 6 to 24 months from disease onset
Change in Perivascular Leakage on Fluorescein Angiography
Perivascular leakage was observed as an increase in hyperfluorescence around retinal vasculature over time on FA exam at midperiphery.
Time frame: 6 to 24 months after disease onset
Choroidal Neovascularization
Choroidal neovascularization was diagnosed when increasingly localized hyperfluorescence at the posterior pole is detected on FA or a hyperreflective subretinal lesion associated with sub or intraretinal fluid on OCT.
Time frame: 6 to 24 months after disease onset
Cataract
Cataract was defined as any lens opacification greater than nuclear or cortical 2+/4 or subcapsular 1+/4
Time frame: 6 to 24 months after disease onset
Ocular Hypertension
Ocular hypertension was defined as an intraocular pressure (IOP) above 21mmHg
Time frame: 6 to 24 months after disease onset
Date of recruitment: June, 2011 through January, 2017 Location: Ophthalmology service -Hospital das Clínicas da Universidade São Paulo
| Milestone | Corticosteroid Monotherapy |
|---|---|
| Started | 12 |
| Completed | 12 |
| Not completed | 0 |
Full-field electroretinogram (ERG) scotopic parameters were evaluated at 12 -month (scotopic parameters: amplitude of scotopic a and b wave, amplitude of maximum scotopic a and b wave, oscillatory potential).
| microvolts | Corticosteroid Monotherapy |
|---|---|
| Scotopic b amplitude | 201 (104 to 352) |
| Maximum scotopic a amplitude | 210 (134 to 336) |
| Maximum scotopic b amplitude | 508 (328 to 728) |
| Oscillatory potential | 92 (48 to 272) |
| Photopic a amplitude | 42 (23 to 63) |
| Photopic B amplitude | 202 (87 to 312) |
| Flicker | 52 (24 to 89) |
Full-field electroretinogram (ERG) scotopic parameters were evaluated at 24 -month (scotopic parameters: amplitude of scotopic a and b wave, amplitude of maximum scotopic a and b wave, oscillatory potential).
| microvolts | Corticosteroid Monotherapy |
|---|---|
| Scotopic b amplitude | 189 (130 to 380) |
| Maximum scotopic a amplitude | 189 (120 to 317) |
| Maximum scotopic b amplitude | 484 (336 to 789) |
| Oscillatory potential | 114 (35 to 259) |
| Photopic a amplitude | 43 (23 to 66) |
| Photopic B amplitude | 186 (111 to 345) |
| Flicker | 54 (29 to 85) |
Full-field electroretinogram (ERG) scotopic parameters at 12 and 24 months were compared (scotopic parameters: amplitude of scotopic a and b wave, amplitude of maximum scotopic a and b wave, oscillatory potential). The worsening of the ERG parameters was defined as a value reduction of ≥ 30 % in any these scotopic ERG parameters at month 12 and month 24. We report the change between the (value at month 24/ the value at month 12)\*100.
| percentage of change on ERG parameters | ERG Stable Group | ERG Worsening Group |
|---|---|---|
| Scotopic b amplitude | 9.5 | -32.9 |
| Maximum scotopic a amplitude | 7 | -21.4 |
| Maximum scotopic b amplitude | 2.8 | -10.8 |
| Oscillatory potential | 5.9 | -47.1 |
| Photopic a amplitude | 0 | -5 |
| Photopic b amplitude | 2.4 | -13.6 |
| Flicker | 6.2 | -6.9 |
Evaluation of anterior chamber (AC) cells was performed at visits 6 months, 12 months, 18 months and 24 months from disease onset, according to the Standardization of Uveitis Nomenclature´s classification of anterior chamber cells. (Am J Ophthalmol, 2005) Any step increase (fluctuation), when comparing sequential dates of follow up (e.g 6 and 12 months) were considered as one episode of clinical worsening in AC cells
| eyes | ERG Stable Group | ERG Worsening Group |
|---|---|---|
| Recurrence or Worsening of Cells in Anterior Chamber | 8 | 0 |
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) Dark dots Score based on pattern of distribution (Sparse/ Numerous) Minimum: 0 (better outcome) Maximum: 8 (worse outcome)
| eyes | ERG Stable Group | ERG Worsening-group |
|---|---|---|
| Increase in the Score of Dark Dots on Indocyanine Green Angiography | 17 | 5 |
Increase of 30% or more in choroidal thickness EDI in consecutive exams on horizontal scan
| eyes | ERG Stable Group | ERG Worsening-group |
|---|---|---|
| Change in Subfoveal Choroidal Thickness on Enhanced Depth Optical Coherence Tomography | 8 | 4 |
Perivascular leakage was observed as an increase in hyperfluorescence around retinal vasculature over time on FA exam at midperiphery.
| eyes | ERG Stable Group | ERG Worsening Group |
|---|---|---|
| Change in Perivascular Leakage on Fluorescein Angiography | 9 | 4 |
Choroidal neovascularization was diagnosed when increasingly localized hyperfluorescence at the posterior pole is detected on FA or a hyperreflective subretinal lesion associated with sub or intraretinal fluid on OCT.
| eyes | ERG Stable Group | ERG Worsening Group |
|---|---|---|
| Choroidal Neovascularization | 2 | 1 |
Cataract was defined as any lens opacification greater than nuclear or cortical 2+/4 or subcapsular 1+/4
| eyes | ERG Stable Group | ERG Worsening Group |
|---|---|---|
| Cataract | 5 | 0 |
Ocular hypertension was defined as an intraocular pressure (IOP) above 21mmHg
| eyes | ERG Stable Group | ERG Worsening Group |
|---|---|---|
| Ocular Hypertension | 7 | 5 |
Collected over 12 and 24 months. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Corticosteroid Monotherapy | 0/12 (0%) | 0/12 (0%) | 6/12 (50%) |
| Event | Corticosteroid Monotherapy |
|---|---|
| Weight gainGeneral disorders | 4/12 |
| Psychosis/ depressionPsychiatric disorders | 2/12 |
Study of clinical, subclinical and electroretinographic outcomes of patients with acute Vogt-Koyanagi-Harada disease treated with corticosteroid monotherapy
| Age, Categorical(Participants) | Corticosteroid Monotherapy |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 10 |
| >=65 years | 1 |
| Age, Continuous(years) | Corticosteroid Monotherapy |
|---|---|
| Median | 31 (15 to 67) |
| Sex: Female, Male(Participants) | Corticosteroid Monotherapy |
|---|---|
| Female | 10 |
| Male | 2 |
| Race (NIH/OMB)(Participants) | Corticosteroid Monotherapy |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 11 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Corticosteroid Monotherapy |
|---|---|
| Brazil | 12 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2011 to primary completion in Jan 2017, 67 months.
Results were first posted in Nov 2024, 7 years 9 months after primary completion.
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