EUCTR2011-001078-25-GB进行中（未招募）1 期
ong-term Follow-up of Patients Who Participated in the Multicenter Uveitis Steroid Treatment Trial (MUST Trial Follow-up Study). - MUST FS
ational Institute of Health, National Eye Institute0 个研究点目标入组 250 人开始时间: 2011年11月21日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Only patients that are currently enrolled in the Multicentre Uveitis Steroid Treatment (MUST) Trial (EudraCT number: 2007-003612-53, REC reference: 07/H0311/200) will be invited to participate in this trial. Therefore the inclusion criteria have not been stipulated for the this trial i.e. no naive patients will be enrolled. All the participants in the MUST trial are at least 18 years old.
- •The main inclusion criteria for the MUST trial are as follows:
- •1) Age 13 years or older ( we did not recruit patients less than 18 years old)
- •2) Diagnosis of non-infectious intermediate uveitis, posterior uveitis, or panuveitis by a MUST-certified ophthalmologist
- •3) Active uveitis of a degree for which systemic corticosteroid therapy is indicated in the judgment of a MUST-certified ophthalmologist or such uveitis active within the last 60 days as determined either by examination by a MUST-certified ophthalmologist or by review of ophthalmic medical records by a MUST-certified ophthalmologist
- •4)Uveitis with or without an associated systemic disease is acceptable; however, the
- •systemic disease must not be sufficiently active that it dictates therapy with oral
- •corticosteroids or immunosuppressive agents at the time of study entry;
- •5) Best-corrected visual acuity (BCVA) of hand motions or better in at least one eye with uveitis
- •6) Baseline intraocular pressure 24 mm Hg or less in all eyes with uveitis
- •7) Collection of required baseline data within 10 days prior to randomization
- •8) Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •Only patients that are currently enrolled in the Multicentre Uveitis Steroid Treatment (MUST) Trial (EudraCT number: 2007-003612-53, REC reference: 07/H0311/200) will be invited to participate in this trial. Therefore the exlusion criteria have not been stipulated for the this trial.
- •The main exclusion criteria for the MUST trial are as follows:
- •1) Diabetes mellitus that is inadequately controlled, according to best medical judgment
- •2) A known allergy to a required study medication
- •3) Uncontrolled glaucoma
- •4) Advanced glaucomatous optic nerve injury meeting the following criteria:
- •For patients able to perform a Humphrey Visual Field:
- •A) Depression of two or more points within 10 degrees of fixation by at least 10 dB
- •B) Mean deviation worse than -15 dB
- •For patients unable to perform a Humphrey Visual Field
- •A) Vertical C/D = 0.9
- •5) A history of scleritis (because of concerns regarding the potential for scleral melting
- •with local corticosteroid therapy)
- •6) Presence of an ocular toxoplasmosis scar
- •7) Pregnancy
- •8) Breastfeeding
- •9) Known human immunodeficiency virus infection or other immunodeficiency disease
- •for which corticosteroid therapy would be contraintraindicated according to best
- •medical judgment;
- •10) Patients for whom participation in the trial would constitute a risk exceeding the
- •potential benefits of study participation, in the judgment of the treating physician;
- •11) Medical problems or drug or alcohol dependence
研究者
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