Who is sponsoring NCT03811366?

NCT03811366 is sponsored by University of Sao Paulo.

What drugs are being tested in NCT03811366?

Interventions in NCT03811366: Corticosteroid monotherapy.

What condition does NCT03811366 study?

NCT03811366 studies Uveomeningoencephalitic Syndrome, Inflammation, Choroid Disease, Visual Impairment.

Is NCT03811366 still recruiting?

NCT03811366 is currently completed. Last updated 17 April 2025.

Are results published for NCT03811366?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-04-17 · How we verify

NCT03811366

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Results posted Last updated 17 April 2025

What this trial tests

NA trial testing Corticosteroid monotherapy in Uveomeningoencephalitic Syndrome in 12 participants. Completed in 31 January 2017.

Timeline

1 June 2011

Primary endpoint
31 January 2017

31 January 2017

Quick facts

Lead sponsor	University of Sao Paulo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	12
Start date	1 June 2011
Primary completion	31 January 2017
Estimated completion	31 January 2017
Sites	1 location across Brazil

Drugs / interventions tested

Corticosteroid monotherapy — full drug profile →

Conditions studied

Uveomeningoencephalitic Syndrome — all drugs for Uveomeningoencephalitic Syndrome →
Inflammation — all drugs for Inflammation →
Choroid Disease — all drugs for Choroid Disease →
Visual Impairment — all drugs for Visual Impairment →

Sponsor

University of Sao Paulo

Who can join

Eligibility, any sex, with Uveomeningoencephalitic Syndrome or Inflammation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Median Values of ERG Scotopic Parameters at 12-month Primary · assessed 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).

Scotopic b amplitude

Group	Value	95% CI
Corticosteroid Monotherapy	201	104 – 352

Maximum scotopic a amplitude

Group	Value	95% CI
Corticosteroid Monotherapy	210	134 – 336

Maximum scotopic b amplitude

Group	Value	95% CI
Corticosteroid Monotherapy	508	328 – 728

Oscillatory potential

Group	Value	95% CI
Corticosteroid Monotherapy	92	48 – 272

Photopic a amplitude

Group	Value	95% CI
Corticosteroid Monotherapy	42	23 – 63

Photopic B amplitude

Group	Value	95% CI
Corticosteroid Monotherapy	202	87 – 312

Flicker

Group	Value	95% CI
Corticosteroid Monotherapy	52	24 – 89

Median Values of ERG Scotopic Parameters at 24-month Primary · assessed 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).

Scotopic b amplitude

Group	Value	95% CI
Corticosteroid Monotherapy	189	130 – 380

Maximum scotopic a amplitude

Group	Value	95% CI
Corticosteroid Monotherapy	189	120 – 317

Maximum scotopic b amplitude

Group	Value	95% CI
Corticosteroid Monotherapy	484	336 – 789

Oscillatory potential

Group	Value	95% CI
Corticosteroid Monotherapy	114	35 – 259

Photopic a amplitude

Group	Value	95% CI
Corticosteroid Monotherapy	43	23 – 66

Photopic B amplitude

Group	Value	95% CI
Corticosteroid Monotherapy	186	111 – 345

Flicker

Group	Value	95% CI
Corticosteroid Monotherapy	54	29 – 85

Variation (Worsening or Improvement) Between 24 and 12 Months of ERG Scotopic Parameters Comparing 24 and 12-months Primary · 12 and 24-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.

Scotopic b amplitude

Group	Value	95% CI
ERG Stable Group	9.5
ERG Worsening Group	-32.9

Maximum scotopic a amplitude

Group	Value	95% CI
ERG Stable Group	7
ERG Worsening Group	-21.4

Maximum scotopic b amplitude

Group	Value	95% CI
ERG Stable Group	2.8
ERG Worsening Group	-10.8

Oscillatory potential

Group	Value	95% CI
ERG Stable Group	5.9
ERG Worsening Group	-47.1

Photopic a amplitude

Group	Value	95% CI
ERG Stable Group	0
ERG Worsening Group	-5

Photopic b amplitude

Group	Value	95% CI
ERG Stable Group	2.4
ERG Worsening Group	-13.6

Flicker

Group	Value	95% CI
ERG Stable Group	6.2
ERG Worsening Group	-6.9

Recurrence or Worsening of Cells in Anterior Chamber Secondary · 6 to 24 months from disease onset.

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

Group	Value	95% CI
ERG Stable Group	8
ERG Worsening Group	0

Increase in the Score of Dark Dots on Indocyanine Green Angiography Secondary · 6 to 24 months from disease onset

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)

Group	Value	95% CI
ERG Stable Group	17
ERG Worsening-group	5

Change in Subfoveal Choroidal Thickness on Enhanced Depth Optical Coherence Tomography Secondary · 6 to 24 months from disease onset

Increase of 30% or more in choroidal thickness EDI in consecutive exams on horizontal scan

Group	Value	95% CI
ERG Stable Group	8
ERG Worsening-group	4

Change in Perivascular Leakage on Fluorescein Angiography Secondary · 6 to 24 months after disease onset

Perivascular leakage was observed as an increase in hyperfluorescence around retinal vasculature over time on FA exam at midperiphery.

Group	Value	95% CI
ERG Stable Group	9
ERG Worsening Group	4

Choroidal Neovascularization Secondary · 6 to 24 months after disease onset

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.

Group	Value	95% CI
ERG Stable Group	2
ERG Worsening Group	1

Cataract Secondary · 6 to 24 months after disease onset

Cataract was defined as any lens opacification greater than nuclear or cortical 2+/4 or subcapsular 1+/4

Group	Value	95% CI
ERG Stable Group	5
ERG Worsening Group	0

Ocular Hypertension Secondary · 6 to 24 months after disease onset

Ocular hypertension was defined as an intraocular pressure (IOP) above 21mmHg

Group	Value	95% CI
ERG Stable Group	7
ERG Worsening Group	5

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 and 24 months. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Corticosteroid Monotherapy

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (2 terms — click to expand)

Reaction	System	Corticosteroid Monotherapy
Weight gain	General disorders	—
Psychosis/ depression	Psychiatric disorders	—

Data from ClinicalTrials.gov NCT03811366 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Full-field electroretinogram (ffERG) over 48 months correlates with baseline retinal dysfunction in Vogt-Koyanagi-Harada disease: a longitudinal study.
Souto FMS, Missaka RFBG, Lavezzo MM, Sakata VM, et al · · 2026 · PMID 41612097 · DOI 10.1007/s10633-025-10080-9

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03811366 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Sao Paulo
Last refreshed: 17 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03811366.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03811366

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other University of Sao Paulo trials

Verify against primary sources