Topical Interferon Gamma for Uveitic macular edema (JAKSTAT2: 11-EI-0167)
Topical Interferon Gamma for Uveitic macular edema (JAKSTAT2: 11-EI-0167)
批准号:
8556880
负责人:
Hatice Sen
金额:
$0.24万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
未结题
起止时间:
至
关键词:
Adverse eventBlindnessCorneaCystoid Macular EdemaDiabetic RetinopathyDropsEarly treatmentEyeFluoresceinInflammationInterferon Type IIInterferon gamma 1bLettersMeasuresOptical Coherence TomographyOutcomeParticipantPathway interactionsPhase I/II TrialPhysiologic Intraocular PressureProtocols documentationReadingReportingSafetySecondary toSeveritiesStaining methodStainsTherapeutic InterventionThickTimeTopical applicationToxic effectUveitisVisual Acuityconjunctivairritationmaculamacular edemameetingsocular surfaceopen labelprimary outcomeprospectiveresponsesuccess
中文摘要
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英文摘要
In this open label phase I/II trial two out of five participants (40%) met the criteria for treatment success as defined by the study protocol (with at least a 25% decrease in central thickness as measured on OCT at Week 1).Participants presented with overall mean decreases in excess central thickness of 13% (ranging from a 102% decrease to a 54% increase) and 10% (ranging from 106% decrease to a 108% increase) in their study eyes at Weeks 1 and 2, respectively.No adverse events have been reported under this IND during the reporting period.Changes in study eye visual acuity (Early Treatment Diabetic Retinopathy Study ETDRS total letters read) ranged from a decrease of 7 letters to an increase of 6 letters read from baseline at Week 1 (mean increase of 0.20 letters read) and ranged from a decrease of 10 letters to an increase in 13 letters read from baseline at Week 2 (mean increase of 4 letters read). Changes in fellow eye visual acuity ranged from a decrease of 1 letter to an increase of 10 letters read at Week 1 (mean increase of 1.60 letters read) and ranged from a decrease of 2 letters to an increase of 15 letters read at Week 2 (mean of 3.2 letters read). Changes in study eye IOP ranged from -2 mmHg to 3 mmHg (mean change of 0.40 mmHg) at Week 1 and ranged from -1 mmHg to 2 mmHg (mean change of 0.40 mmHg) at Week 2. Changes in fellow eye IOP ranged from -14 mmHg to 3 mmHg (mean change of -1.60 mmHg) at Week 1 and ranged from -15 mmHg to 4 mmHg (mean change of -2.20 mmHg) at Week 2.
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会议论文
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批准号:8556865
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项目类别:
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资助金额:$4.87万
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财政年份:--
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负责人:Hatice Sen
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依托单位:
Uveitis and Ocular Immunology Fellowship
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批准号:8339826
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资助金额:$30.48万
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批准号:8938357
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资助金额:$2.92万
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资助金额:$6.56万
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批准号:10020079
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资助金额:$38.56万
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资助金额:$6.24万
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资助金额:$14.43万
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依托单位:
LI/NEI Repository Protocol
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批准号:9362409
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资助金额:$0.52万
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资助金额:$17.26万
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依托单位:
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依托单位:
海外基金