Trial Outcomes & Findings for Multimodal Analysis and Electroretinogram in VKH From Acute Onset - Part I (NCT NCT03811366)
NCT ID: NCT03811366
Last Updated: 2025-04-17
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
assessed at 12-month
Results posted on
2025-04-17
Participant Flow
Date of recruitment: June, 2011 through January, 2017 Location: Ophthalmology service -Hospital das Clínicas da Universidade São Paulo
Unit of analysis: Eyes
Participant milestones
| Measure |
Corticosteroid Monotherapy
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.
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.
|
|---|---|
|
Overall Study
STARTED
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12 24
|
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Overall Study
COMPLETED
|
12 24
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multimodal Analysis and Electroretinogram in VKH From Acute Onset - Part I
Baseline characteristics by cohort
| Measure |
Corticosteroid Monotherapy
n=12 Participants
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.
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.
prednisolone and prednisone
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
31 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: assessed at 12-monthFull-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).
Outcome measures
| Measure |
Corticosteroid Monotherapy
n=12 Participants
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.
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.
|
ERG Worsening Group
The worsening of the ERG parameters was defined as a value reduction of ≥ 30 % in any scotopic ERG parameter, which was confirmed in two consecutive examinations
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|---|---|---|
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Median Values of ERG Scotopic Parameters at 12-month
Scotopic b amplitude
|
201 microvolts
Interval 104.0 to 352.0
|
—
|
|
Median Values of ERG Scotopic Parameters at 12-month
Maximum scotopic a amplitude
|
210 microvolts
Interval 134.0 to 336.0
|
—
|
|
Median Values of ERG Scotopic Parameters at 12-month
Maximum scotopic b amplitude
|
508 microvolts
Interval 328.0 to 728.0
|
—
|
|
Median Values of ERG Scotopic Parameters at 12-month
Oscillatory potential
|
92 microvolts
Interval 48.0 to 272.0
|
—
|
|
Median Values of ERG Scotopic Parameters at 12-month
Photopic a amplitude
|
42 microvolts
Interval 23.0 to 63.0
|
—
|
|
Median Values of ERG Scotopic Parameters at 12-month
Photopic B amplitude
|
202 microvolts
Interval 87.0 to 312.0
|
—
|
|
Median Values of ERG Scotopic Parameters at 12-month
Flicker
|
52 microvolts
Interval 24.0 to 89.0
|
—
|
PRIMARY outcome
Timeframe: assessed at 24-monthFull-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).
Outcome measures
| Measure |
Corticosteroid Monotherapy
n=24 eyes
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.
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.
|
ERG Worsening Group
The worsening of the ERG parameters was defined as a value reduction of ≥ 30 % in any scotopic ERG parameter, which was confirmed in two consecutive examinations
|
|---|---|---|
|
Median Values of ERG Scotopic Parameters at 24-month
Scotopic b amplitude
|
189 microvolts
Interval 130.0 to 380.0
|
—
|
|
Median Values of ERG Scotopic Parameters at 24-month
Maximum scotopic a amplitude
|
189 microvolts
Interval 120.0 to 317.0
|
—
|
|
Median Values of ERG Scotopic Parameters at 24-month
Maximum scotopic b amplitude
|
484 microvolts
Interval 336.0 to 789.0
|
—
|
|
Median Values of ERG Scotopic Parameters at 24-month
Oscillatory potential
|
114 microvolts
Interval 35.0 to 259.0
|
—
|
|
Median Values of ERG Scotopic Parameters at 24-month
Photopic a amplitude
|
43 microvolts
Interval 23.0 to 66.0
|
—
|
|
Median Values of ERG Scotopic Parameters at 24-month
Photopic B amplitude
|
186 microvolts
Interval 111.0 to 345.0
|
—
|
|
Median Values of ERG Scotopic Parameters at 24-month
Flicker
|
54 microvolts
Interval 29.0 to 85.0
|
—
|
PRIMARY outcome
Timeframe: 12 and 24-monthsPopulation: One patient had an eye classified as ERG stable group and the other eye as ERG worsening group thus the sum of both groups exceed the total 12 participants
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.
Outcome measures
| Measure |
Corticosteroid Monotherapy
n=17 eyes
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.
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.
|
ERG Worsening Group
n=7 eyes
The worsening of the ERG parameters was defined as a value reduction of ≥ 30 % in any scotopic ERG parameter, which was confirmed in two consecutive examinations
|
|---|---|---|
|
Variation (Worsening or Improvement) Between 24 and 12 Months of ERG Scotopic Parameters Comparing 24 and 12-months
Scotopic b amplitude
|
9.5 percentage of change on ERG parameters
|
-32.9 percentage of change on ERG parameters
|
|
Variation (Worsening or Improvement) Between 24 and 12 Months of ERG Scotopic Parameters Comparing 24 and 12-months
Maximum scotopic a amplitude
|
7 percentage of change on ERG parameters
|
-21.4 percentage of change on ERG parameters
|
|
Variation (Worsening or Improvement) Between 24 and 12 Months of ERG Scotopic Parameters Comparing 24 and 12-months
Maximum scotopic b amplitude
|
2.8 percentage of change on ERG parameters
|
-10.8 percentage of change on ERG parameters
|
|
Variation (Worsening or Improvement) Between 24 and 12 Months of ERG Scotopic Parameters Comparing 24 and 12-months
Oscillatory potential
|
5.9 percentage of change on ERG parameters
|
-47.1 percentage of change on ERG parameters
|
|
Variation (Worsening or Improvement) Between 24 and 12 Months of ERG Scotopic Parameters Comparing 24 and 12-months
Photopic a amplitude
|
0 percentage of change on ERG parameters
|
-5 percentage of change on ERG parameters
|
|
Variation (Worsening or Improvement) Between 24 and 12 Months of ERG Scotopic Parameters Comparing 24 and 12-months
Photopic b amplitude
|
2.4 percentage of change on ERG parameters
|
-13.6 percentage of change on ERG parameters
|
|
Variation (Worsening or Improvement) Between 24 and 12 Months of ERG Scotopic Parameters Comparing 24 and 12-months
Flicker
|
6.2 percentage of change on ERG parameters
|
-6.9 percentage of change on ERG parameters
|
SECONDARY outcome
Timeframe: 6 to 24 months from disease onset.Population: One patient had an eye classified as ERG stable group and the other eye as ERG worsening group thus the sum of both groups exceed the total 12 participants
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
Outcome measures
| Measure |
Corticosteroid Monotherapy
n=17 eyes
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.
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.
|
ERG Worsening Group
n=7 eyes
The worsening of the ERG parameters was defined as a value reduction of ≥ 30 % in any scotopic ERG parameter, which was confirmed in two consecutive examinations
|
|---|---|---|
|
Recurrence or Worsening of Cells in Anterior Chamber
|
8 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: 6 to 24 months from disease onsetPopulation: One patient had an eye classified as ERG stable group and the other eye as ERG worsening group thus the sum of both groups exceed the total 12 participants
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)
Outcome measures
| Measure |
Corticosteroid Monotherapy
n=17 eyes
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.
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.
|
ERG Worsening Group
n=7 eyes
The worsening of the ERG parameters was defined as a value reduction of ≥ 30 % in any scotopic ERG parameter, which was confirmed in two consecutive examinations
|
|---|---|---|
|
Increase in the Score of Dark Dots on Indocyanine Green Angiography
|
17 eyes
|
5 eyes
|
SECONDARY outcome
Timeframe: 6 to 24 months from disease onsetPopulation: One patient had an eye classified as ERG stable group and the other eye as ERG worsening group thus the sum of both groups exceed the total 12 participants
Increase of 30% or more in choroidal thickness EDI in consecutive exams on horizontal scan
Outcome measures
| Measure |
Corticosteroid Monotherapy
n=17 eyes
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.
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.
|
ERG Worsening Group
n=7 eyes
The worsening of the ERG parameters was defined as a value reduction of ≥ 30 % in any scotopic ERG parameter, which was confirmed in two consecutive examinations
|
|---|---|---|
|
Change in Subfoveal Choroidal Thickness on Enhanced Depth Optical Coherence Tomography
|
8 eyes
|
4 eyes
|
SECONDARY outcome
Timeframe: 6 to 24 months after disease onsetPopulation: One patient had an eye classified as ERG stable group and the other eye as ERG worsening group thus the sum of both groups exceed the total 12 participants
Perivascular leakage was observed as an increase in hyperfluorescence around retinal vasculature over time on FA exam at midperiphery.
Outcome measures
| Measure |
Corticosteroid Monotherapy
n=17 eyes
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.
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.
|
ERG Worsening Group
n=7 eyes
The worsening of the ERG parameters was defined as a value reduction of ≥ 30 % in any scotopic ERG parameter, which was confirmed in two consecutive examinations
|
|---|---|---|
|
Change in Perivascular Leakage on Fluorescein Angiography
|
9 eyes
|
4 eyes
|
SECONDARY outcome
Timeframe: 6 to 24 months after disease onsetPopulation: One patient had an eye classified as ERG stable group and the other eye as ERG worsening group thus the sum of both groups exceed the total 12 participants
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.
Outcome measures
| Measure |
Corticosteroid Monotherapy
n=17 eyes
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.
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.
|
ERG Worsening Group
n=7 eyes
The worsening of the ERG parameters was defined as a value reduction of ≥ 30 % in any scotopic ERG parameter, which was confirmed in two consecutive examinations
|
|---|---|---|
|
Choroidal Neovascularization
|
2 eyes
|
1 eyes
|
SECONDARY outcome
Timeframe: 6 to 24 months after disease onsetPopulation: One patient had an eye classified as ERG stable group and the other eye as ERG worsening group thus the sum of both groups exceed the total 12 participants
Cataract was defined as any lens opacification greater than nuclear or cortical 2+/4 or subcapsular 1+/4
Outcome measures
| Measure |
Corticosteroid Monotherapy
n=17 eyes
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.
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.
|
ERG Worsening Group
n=7 eyes
The worsening of the ERG parameters was defined as a value reduction of ≥ 30 % in any scotopic ERG parameter, which was confirmed in two consecutive examinations
|
|---|---|---|
|
Cataract
|
5 eyes
|
0 eyes
|
SECONDARY outcome
Timeframe: 6 to 24 months after disease onsetPopulation: One patient had an eye classified as ERG stable group and the other eye as ERG worsening group thus the sum of both groups exceed the total 12 participants
Ocular hypertension was defined as an intraocular pressure (IOP) above 21mmHg
Outcome measures
| Measure |
Corticosteroid Monotherapy
n=17 eyes
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.
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.
|
ERG Worsening Group
n=7 eyes
The worsening of the ERG parameters was defined as a value reduction of ≥ 30 % in any scotopic ERG parameter, which was confirmed in two consecutive examinations
|
|---|---|---|
|
Ocular Hypertension
|
7 eyes
|
5 eyes
|
Adverse Events
Corticosteroid Monotherapy
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Corticosteroid Monotherapy
n=12 participants at risk
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.
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.
|
|---|---|
|
Psychiatric disorders
Psychosis/ depression
|
16.7%
2/12 • Number of events 2 • 12 and 24 months
1. Weight gain 2. Psychosis/ Depression
|
|
General disorders
Weight gain
|
33.3%
4/12 • Number of events 4 • 12 and 24 months
1. Weight gain 2. Psychosis/ Depression
|
Additional Information
Dra Joyce Hisae Yamamoto
Hospital das clínicas- Faculdade de Medicina da Universidade São Paulo
Phone: 41988263757
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place