N/A
N=12
Multimodal Analysis and Electroretinogram in VKH From Acute Onset - Part I
Uveomeningoencephalitic Syndrome · Inflammation · Choroid Disease · Visual Impairment
Bottom Line
View on ClinicalTrials.gov: NCT03811366 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Median Values of ERG Scotopic Parameters at 12-month — 201; 210; 508; 92 microvolts — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Corticosteroid monotherapy (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of Sao Paulo
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Values of ERG Scotopic Parameters at 12-month |
201; 210; 508; 92; 42; 202 | <0.001 sig |
| PRIMARY Median Values of ERG Scotopic Parameters at 24-month |
189; 189; 484; 114; 43; 186 | — |
| PRIMARY Variation (Worsening or Improvement) Between 24 and 12 Months of ERG Scotopic Parameters Comparing 24 and 12-months |
9.5; -32.9; 7; -21.4; 2.8; -10.8 | — |
| SECONDARY Recurrence or Worsening of Cells in Anterior Chamber |
8; 0 | 0.054 |
| SECONDARY Increase in the Score of Dark Dots on Indocyanine Green Angiography |
17; 5 | 0.478 |
| SECONDARY Change in Subfoveal Choroidal Thickness on Enhanced Depth Optical Coherence Tomography |
8; 4 | — |
| SECONDARY Change in Perivascular Leakage on Fluorescein Angiography |
9; 4 | 0.936 |
| SECONDARY Choroidal Neovascularization |
2; 1 | 0.853 |
| SECONDARY Cataract |
5; 0 | 0.272 |
| SECONDARY Ocular Hypertension |
7; 5 | 0.983 |
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.
Eligibility Criteria
Inclusion Criteria
- clinical diagnosis of Vogt-Koyanagi-Harada disease
- acute onset with no previous treatment
Exclusion Criteria
- non-acute VKHD
- media opacities
Data sourced from ClinicalTrials.gov (NCT03811366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.