Treatment of Uveitic Macular Edema with Intravitreal Methotrexate (11-ei-0107)
Treatment of Uveitic Macular Edema with Intravitreal Methotrexate (11-ei-0107)
批准号:
8938357
负责人:
Hatice Sen
金额:
$2.42万
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:
AccountingAdverse eventCaucasiansCaucasoid RaceChronicClinicalClinical TrialsDiabetic RetinopathyDoseEarly treatmentElectroretinographyEligibility DeterminationEnrollmentEvaluationExtravasationEyeFemaleFluorescein AngiographyFundusGoalsImageImmunosuppressionInflammationInjection of therapeutic agentIntermediate UveitisLeucovorinMethotrexateNot Hispanic or LatinoOutcomeOutcome MeasurePanuveitisParticipantPatientsPatternPharmaceutical PreparationsPhasePopulation StudyPosterior UveitisProtocols documentationRecruitment ActivityRecurrenceReportingRetinalSafetySamplingSecondary toSerious Adverse EventSeveritiesSteroidsTherapeutic immunosuppressionThickToxic effectUveitisVisitVisual AcuityWithdrawaldesignexperienceintravitreal injectionmaculamacular edemameetingsprimary outcomeprospectivesecondary outcomesuccess
中文摘要
点击翻译按钮获取中文摘要
英文摘要
The total enrollment goal for this study is seven participants. Five participants with uveitic macular edema determined on OCT will be initially enrolled and included in the primary analysis. An additional two participants may be enrolled to account for participants who withdraw from the study prior to Week 12. ERG will be performed to assess the afety of multiple intravitreal injections of methotrexate in uveitis patients.
To date, two Caucasian female participants of Non-Hispanic origin have been enrolled. One participant has been enrolled since the last continuing review. Participant 001 has completed the induction phase of the protocol and is currently in the PRN phase of the protocol. Participant 002 was enrolled on November 10, 2011 and is also currently in the PRN phase of the protocol.
Accrual for this study has been satisfactory given that recruitment was temporarily halted due to a temporary shortage of the leucovorin drug supply. We are continuing to screen patients for enrollment in order to recruit the needed number of participants.
No samples are stored for this study.
To date, no serious adverse events have been reported.
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海外基金