Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-02-25 @ 5:35 PM
Study NCT ID:
NCT03811366
Status:
COMPLETED
Last Update Posted:
2025-04-17
First Post:
2019-01-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multimodal Analysis and Electroretinogram in VKH From Acute Onset - Part I
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014607', 'term': 'Uveomeningoencephalitic Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014786', 'term': 'Vision Disorders'}], 'ancestors': [{'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vmsakata@yahoo.com.br', 'phone': '41988263757', 'title': 'Dra Joyce Hisae Yamamoto', 'organization': 'Hospital das clínicas- Faculdade de Medicina da Universidade São Paulo'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 and 24 months', 'description': '1. Weight gain\n2. Psychosis/ Depression', 'eventGroups': [{'id': 'EG000', 'title': 'Corticosteroid Monotherapy', 'description': '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.\n\nTreatment 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.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Psychosis/ depression', 'notes': 'Psychosis/ depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Median Values of ERG Scotopic Parameters at 12-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Corticosteroid Monotherapy', 'description': '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.\n\nTreatment 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.'}], 'classes': [{'title': 'Scotopic b amplitude', 'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000', 'lowerLimit': '104', 'upperLimit': '352'}]}]}, {'title': 'Maximum scotopic a amplitude', 'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000', 'lowerLimit': '134', 'upperLimit': '336'}]}]}, {'title': 'Maximum scotopic b amplitude', 'categories': [{'measurements': [{'value': '508', 'groupId': 'OG000', 'lowerLimit': '328', 'upperLimit': '728'}]}]}, {'title': 'Oscillatory potential', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000', 'lowerLimit': '48', 'upperLimit': '272'}]}]}, {'title': 'Photopic a amplitude', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '63'}]}]}, {'title': 'Photopic B amplitude', 'categories': [{'measurements': [{'value': '202', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '312'}]}]}, {'title': 'Flicker', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '89'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'significance when p\\<0;05', 'statisticalMethod': 'generalized estimated equation', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'generalized estimated equation with normal distribution and logarithmic link function'}], 'paramType': 'MEDIAN', 'timeFrame': 'assessed at 12-month', 'description': '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).', 'unitOfMeasure': 'microvolts', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'PRIMARY', 'title': 'Median Values of ERG Scotopic Parameters at 24-month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}, {'units': 'eyes', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Corticosteroid Monotherapy', 'description': '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.\n\nTreatment 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.'}], 'classes': [{'title': 'Scotopic b amplitude', 'categories': [{'measurements': [{'value': '189', 'groupId': 'OG000', 'lowerLimit': '130', 'upperLimit': '380'}]}]}, {'title': 'Maximum scotopic a amplitude', 'categories': [{'measurements': [{'value': '189', 'groupId': 'OG000', 'lowerLimit': '120', 'upperLimit': '317'}]}]}, {'title': 'Maximum scotopic b amplitude', 'categories': [{'measurements': [{'value': '484', 'groupId': 'OG000', 'lowerLimit': '336', 'upperLimit': '789'}]}]}, {'title': 'Oscillatory potential', 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '259'}]}]}, {'title': 'Photopic a amplitude', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '66'}]}]}, {'title': 'Photopic B amplitude', 'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000', 'lowerLimit': '111', 'upperLimit': '345'}]}]}, {'title': 'Flicker', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '85'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'assessed at 24-month', 'description': '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).', 'unitOfMeasure': 'microvolts', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}, {'type': 'PRIMARY', 'title': 'Variation (Worsening or Improvement) Between 24 and 12 Months of ERG Scotopic Parameters Comparing 24 and 12-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ERG Stable Group', 'description': 'The stability of the ERG parameters was defined as a value reduction of \\< 30 % in any scotopic ERG parameter, which was confirmed in two consecutive examinations'}, {'id': 'OG001', 'title': 'ERG Worsening Group', 'description': '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'}], 'classes': [{'title': 'Scotopic b amplitude', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}, {'value': '-32.9', 'groupId': 'OG001'}]}]}, {'title': 'Maximum scotopic a amplitude', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '-21.4', 'groupId': 'OG001'}]}]}, {'title': 'Maximum scotopic b amplitude', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '-10.8', 'groupId': 'OG001'}]}]}, {'title': 'Oscillatory potential', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}, {'value': '-47.1', 'groupId': 'OG001'}]}]}, {'title': 'Photopic a amplitude', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '-5', 'groupId': 'OG001'}]}]}, {'title': 'Photopic b amplitude', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '-13.6', 'groupId': 'OG001'}]}]}, {'title': 'Flicker', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}, {'value': '-6.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 and 24-months', 'description': '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.', 'unitOfMeasure': 'percentage of change on ERG parameters', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': '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'}, {'type': 'SECONDARY', 'title': 'Recurrence or Worsening of Cells in Anterior Chamber', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ERG Stable Group', 'description': 'The stability of the ERG parameters was defined as a value reduction of \\< 30 % in any scotopic ERG parameter, which was confirmed in two consecutive examinations'}, {'id': 'OG001', 'title': 'ERG Worsening Group', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.054', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'significance when p\\<0.05', 'groupDescription': 'Recurrence or worsening of cells in anterior chamber in ERG-stable and ERG worsening group.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '6 to 24 months from disease onset.', 'description': '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', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': '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'}, {'type': 'SECONDARY', 'title': 'Increase in the Score of Dark Dots on Indocyanine Green Angiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ERG Stable Group', 'description': 'The stability of the ERG parameters was defined as a value reduction of \\< 30 % in any scotopic ERG parameter, which was confirmed in two consecutive examinations'}, {'id': 'OG001', 'title': 'ERG Worsening-group', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.478', 'groupIds': ['OG000'], 'pValueComment': '17 eyes presented dark dots fluctuation during follow up in stable ERG group when compared to 5 eyes in worsening ERG group.', 'statisticalMethod': 'generalized estimated equation', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimated equation with Poisson distribution and identity link function supposing an interchangeable correlation matrix between the eyes'}], 'paramType': 'NUMBER', 'timeFrame': '6 to 24 months from disease onset', '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) Dark dots Score based on pattern of distribution (Sparse/ Numerous) Minimum: 0 (better outcome) Maximum: 8 (worse outcome)', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': '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'}, {'type': 'SECONDARY', 'title': 'Change in Subfoveal Choroidal Thickness on Enhanced Depth Optical Coherence Tomography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ERG Stable Group', 'description': 'The stability of the ERG parameters was defined as a value reduction of \\< 30 % in any scotopic ERG parameter, which was confirmed in two consecutive examinations'}, {'id': 'OG001', 'title': 'ERG Worsening-group', 'description': 'he 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'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '6 to 24 months from disease onset', 'description': 'Increase of 30% or more in choroidal thickness EDI in consecutive exams on horizontal scan', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': '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'}, {'type': 'SECONDARY', 'title': 'Change in Perivascular Leakage on Fluorescein Angiography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ERG Stable Group', 'description': 'The stability of the ERG parameters was defined as a value reduction of \\< 30 % in any scotopic ERG parameter, which was confirmed in two consecutive examinations'}, {'id': 'OG001', 'title': 'ERG Worsening Group', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.936', 'groupIds': ['OG000'], 'groupDescription': 'Change in perivascular leakage in ERG-stable and ERG- worsening groups.', 'statisticalMethod': 'Generalized estimated equation', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimated equation with binomial distribution and logit link function, supposing an interchangeable correlation matrix between the eyes;', 'nonInferiorityComment': '9 (52.9%) eyes in ERG stable group x 4 (57.1%)eyes presented change in perivascular leakage during follow up (p=0.936).'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '6 to 24 months after disease onset', 'description': 'Perivascular leakage was observed as an increase in hyperfluorescence around retinal vasculature over time on FA exam at midperiphery.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': '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'}, {'type': 'SECONDARY', 'title': 'Choroidal Neovascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ERG Stable Group', 'description': 'The stability of the ERG parameters was defined as a value reduction of \\< 30 % in any scotopic ERG parameter, which was confirmed in two consecutive examinations'}, {'id': 'OG001', 'title': 'ERG Worsening Group', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.853', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'significance when p\\<0.05', 'statisticalMethod': 'Generalized estimated equation', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimated equation with binomial distribution and logit link function, supposing an interchangeable correlation matrix between the eyes;'}], 'paramType': 'NUMBER', 'timeFrame': '6 to 24 months after disease onset', 'description': '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.', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': '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'}, {'type': 'SECONDARY', 'title': 'Cataract', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ERG Stable Group', 'description': 'The stability of the ERG parameters was defined as a value reduction of \\< 30 % in any scotopic ERG parameter, which was confirmed in two consecutive examinations'}, {'id': 'OG001', 'title': 'ERG Worsening Group', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.272', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'significance when p\\<0.05', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '6 to 24 months after disease onset', 'description': 'Cataract was defined as any lens opacification greater than nuclear or cortical 2+/4 or subcapsular 1+/4', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': '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'}, {'type': 'SECONDARY', 'title': 'Ocular Hypertension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ERG Stable Group', 'description': 'The stability of the ERG parameters was defined as a value reduction of \\< 30 % in any scotopic ERG parameter, which was confirmed in two consecutive examinations'}, {'id': 'OG001', 'title': 'ERG Worsening Group', 'description': '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'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.983', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'significance when p\\<0.05', 'statisticalMethod': 'Generalized estimated equation with bino', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Generalized estimated equation with binomial distribution and logit link function, supposing an interchangeable correlation matrix between the eyes'}], 'paramType': 'NUMBER', 'timeFrame': '6 to 24 months after disease onset', 'description': 'Ocular hypertension was defined as an intraocular pressure (IOP) above 21mmHg', 'unitOfMeasure': 'eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': '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'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Corticosteroid Monotherapy', 'description': '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.\n\nTreatment 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '24', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '24', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Eyes', 'recruitmentDetails': 'Date of recruitment: June, 2011 through January, 2017 Location: Ophthalmology service -Hospital das Clínicas da Universidade São Paulo'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Corticosteroid Monotherapy', 'description': '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.\n\nTreatment 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.\n\nprednisolone and prednisone'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000', 'lowerLimit': '15', 'upperLimit': '67'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Study of clinical, subclinical and electroretinographic outcomes of patients with acute Vogt-Koyanagi-Harada disease treated with corticosteroid monotherapy'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-03-26', 'size': 1049404, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-26T20:49', 'hasProtocol': True}, {'date': '2025-03-26', 'size': 268882, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-03-26T20:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All patients were treated with a standard high-dose corticosteroid'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2019-01-10', 'resultsFirstSubmitDate': '2020-02-03', 'studyFirstSubmitQcDate': '2019-01-17', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-29', 'studyFirstPostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median Values of ERG Scotopic Parameters at 12-month', 'timeFrame': 'assessed at 12-month', 'description': '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).'}, {'measure': 'Median Values of ERG Scotopic Parameters at 24-month', 'timeFrame': 'assessed at 24-month', 'description': '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).'}, {'measure': 'Variation (Worsening or Improvement) Between 24 and 12 Months of ERG Scotopic Parameters Comparing 24 and 12-months', 'timeFrame': '12 and 24-months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Recurrence or Worsening of Cells in Anterior Chamber', 'timeFrame': '6 to 24 months from disease onset.', 'description': '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'}, {'measure': 'Increase in the Score of Dark Dots on Indocyanine Green Angiography', 'timeFrame': '6 to 24 months from disease onset', '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) Dark dots Score based on pattern of distribution (Sparse/ Numerous) Minimum: 0 (better outcome) Maximum: 8 (worse outcome)'}, {'measure': 'Change in Subfoveal Choroidal Thickness on Enhanced Depth Optical Coherence Tomography', 'timeFrame': '6 to 24 months from disease onset', 'description': 'Increase of 30% or more in choroidal thickness EDI in consecutive exams on horizontal scan'}, {'measure': 'Change in Perivascular Leakage on Fluorescein Angiography', 'timeFrame': '6 to 24 months after disease onset', 'description': 'Perivascular leakage was observed as an increase in hyperfluorescence around retinal vasculature over time on FA exam at midperiphery.'}, {'measure': 'Choroidal Neovascularization', 'timeFrame': '6 to 24 months after disease onset', 'description': '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.'}, {'measure': 'Cataract', 'timeFrame': '6 to 24 months after disease onset', 'description': 'Cataract was defined as any lens opacification greater than nuclear or cortical 2+/4 or subcapsular 1+/4'}, {'measure': 'Ocular Hypertension', 'timeFrame': '6 to 24 months after disease onset', 'description': 'Ocular hypertension was defined as an intraocular pressure (IOP) above 21mmHg'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Uveomeningoencephalitic Syndrome', 'Inflammation', 'Choroid Disease', 'Visual Impairment']}, 'referencesModule': {'references': [{'pmid': '26875727', 'type': 'BACKGROUND', 'citation': 'Du L, Kijlstra A, Yang P. Vogt-Koyanagi-Harada disease: Novel insights into pathophysiology, diagnosis and treatment. Prog Retin Eye Res. 2016 May;52:84-111. doi: 10.1016/j.preteyeres.2016.02.002. Epub 2016 Feb 11.'}, {'pmid': '27008848', 'type': 'BACKGROUND', 'citation': 'Lavezzo MM, Sakata VM, Morita C, Rodriguez EE, Abdallah SF, da Silva FT, Hirata CE, Yamamoto JH. Vogt-Koyanagi-Harada disease: review of a rare autoimmune disease targeting antigens of melanocytes. Orphanet J Rare Dis. 2016 Mar 24;11:29. doi: 10.1186/s13023-016-0412-4.'}, {'pmid': '17435969', 'type': 'BACKGROUND', 'citation': 'Rao NA. Pathology of Vogt-Koyanagi-Harada disease. Int Ophthalmol. 2007 Apr-Jun;27(2-3):81-5. doi: 10.1007/s10792-006-9029-2. Epub 2007 Apr 14.'}, {'pmid': '2025171', 'type': 'BACKGROUND', 'citation': 'Rubsamen PE, Gass JD. Vogt-Koyanagi-Harada syndrome. Clinical course, therapy, and long-term visual outcome. Arch Ophthalmol. 1991 May;109(5):682-7. doi: 10.1001/archopht.1991.01080050096037.'}, {'pmid': '29948499', 'type': 'BACKGROUND', 'citation': 'Herbort CP Jr, Abu El Asrar AM, Takeuchi M, Pavesio CE, Couto C, Hedayatfar A, Maruyama K, Rao X, Silpa-Archa S, Somkijrungroj T. Catching the therapeutic window of opportunity in early initial-onset Vogt-Koyanagi-Harada uveitis can cure the disease. Int Ophthalmol. 2019 Jun;39(6):1419-1425. doi: 10.1007/s10792-018-0949-4. Epub 2018 Jun 11.'}, {'pmid': '18672226', 'type': 'BACKGROUND', 'citation': 'Yang P, Fang W, Wang L, Wen F, Wu W, Kijlstra A. Study of macular function by multifocal electroretinography in patients with Vogt-Koyanagi-Harada syndrome. Am J Ophthalmol. 2008 Nov;146(5):767-71. doi: 10.1016/j.ajo.2008.05.044. Epub 2008 Jul 30.'}, {'pmid': '17103022', 'type': 'BACKGROUND', 'citation': 'Chee SP, Jap A, Bacsal K. Spectrum of Vogt-Koyanagi-Harada disease in Singapore. Int Ophthalmol. 2007 Apr-Jun;27(2-3):137-42. doi: 10.1007/s10792-006-9009-6. Epub 2006 Nov 11.'}, {'pmid': '29702075', 'type': 'BACKGROUND', 'citation': 'Yuan W, Zhou C, Cao Q, Du Z, Hu R, Wang Y, Kijlstra A, Yang P. Longitudinal Study of Visual Function in Vogt-Koyanagi-Harada Disease Using Full-Field Electroretinography. Am J Ophthalmol. 2018 Jul;191:92-99. doi: 10.1016/j.ajo.2018.04.013. Epub 2018 Apr 25.'}, {'pmid': '15761760', 'type': 'BACKGROUND', 'citation': 'Chee SP, Luu CD, Cheng CL, Lim WK, Jap A. Visual function in Vogt-Koyanagi-Harada patients. Graefes Arch Clin Exp Ophthalmol. 2005 Aug;243(8):785-90. doi: 10.1007/s00417-005-1156-3. Epub 2005 Mar 11.'}, {'pmid': '19781687', 'type': 'BACKGROUND', 'citation': 'da Silva FT, Hirata CE, Olivalves E, Oyamada MK, Yamamoto JH. Fundus-based and electroretinographic strategies for stratification of late-stage Vogt-Koyanagi-Harada disease patients. Am J Ophthalmol. 2009 Dec;148(6):939-45.e3. doi: 10.1016/j.ajo.2009.06.029. Epub 2009 Sep 24.'}, {'pmid': '18795232', 'type': 'BACKGROUND', 'citation': 'Tugal-Tutkun I, Herbort CP, Khairallah M; Angiography Scoring for Uveitis Working Group (ASUWOG). Scoring of dual fluorescein and ICG inflammatory angiographic signs for the grading of posterior segment inflammation (dual fluorescein and ICG angiographic scoring system for uveitis). Int Ophthalmol. 2010 Oct;30(5):539-52. doi: 10.1007/s10792-008-9263-x. Epub 2008 Sep 16.'}, {'pmid': '29666121', 'type': 'BACKGROUND', 'citation': 'Nakayama M, Keino H, Watanabe T, Okada AA. Clinical features and visual outcomes of 111 patients with new-onset acute Vogt-Koyanagi-Harada disease treated with pulse intravenous corticosteroids. Br J Ophthalmol. 2019 Feb;103(2):274-278. doi: 10.1136/bjophthalmol-2017-311691. Epub 2018 Apr 17.'}, {'pmid': '19151926', 'type': 'BACKGROUND', 'citation': 'Kawaguchi T, Horie S, Bouchenaki N, Ohno-Matsui K, Mochizuki M, Herbort CP. Suboptimal therapy controls clinically apparent disease but not subclinical progression of Vogt-Koyanagi-Harada disease. Int Ophthalmol. 2010 Feb;30(1):41-50. doi: 10.1007/s10792-008-9288-1. Epub 2009 Jan 17.'}, {'pmid': '27844182', 'type': 'BACKGROUND', 'citation': 'Herbort CP Jr, Abu El Asrar AM, Yamamoto JH, Pavesio CE, Gupta V, Khairallah M, Tugal-Tutkun I, Soheilian M, Takeuchi M, Papadia M. Reappraisal of the management of Vogt-Koyanagi-Harada disease: sunset glow fundus is no more a fatality. Int Ophthalmol. 2017 Dec;37(6):1383-1395. doi: 10.1007/s10792-016-0395-0. Epub 2016 Nov 14.'}, {'pmid': '27535102', 'type': 'BACKGROUND', 'citation': "Abu El-Asrar AM, Dosari M, Hemachandran S, Gikandi PW, Al-Muammar A. Mycophenolate mofetil combined with systemic corticosteroids prevents progression to chronic recurrent inflammation and development of 'sunset glow fundus' in initial-onset acute uveitis associated with Vogt-Koyanagi-Harada disease. Acta Ophthalmol. 2017 Feb;95(1):85-90. doi: 10.1111/aos.13189. Epub 2016 Aug 18."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of Vogt-Koyanagi-Harada disease\n* acute onset with no previous treatment\n\nExclusion Criteria:\n\n* non-acute VKHD\n* media opacities'}, 'identificationModule': {'nctId': 'NCT03811366', 'briefTitle': 'Multimodal Analysis and Electroretinogram in VKH From Acute Onset - Part I', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Multimodal Analysis and Electroretinogram in VKH From Acute Onset - a Prospective Study', 'orgStudyIdInfo': {'id': 'Brazilian VKH Study Group I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Corticosteroid monotherapy', 'description': '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.\n\nTreatment 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.', 'interventionNames': ['Drug: Corticosteroid monotherapy']}], 'interventions': [{'name': 'Corticosteroid monotherapy', 'type': 'DRUG', 'otherNames': ['Prednisone arm', 'Corticosteroid pulsetherapy arm', 'Methilprednisolone arm'], 'description': 'Patients will receive corticosteroid monotherapy as a pulsetherapy (1000mg/ day for 3 days) followed by oral corticosteroid.', 'armGroupLabels': ['Corticosteroid monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clinicas HCFMUSP, Faculdade de Medicina Universidade de Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Joyce H Yamamoto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor, person-in-charge of Uveitis Service', 'investigatorFullName': 'Joyce Hisae Yamamoto', 'investigatorAffiliation': 'University of Sao Paulo'}}}}