Multicenter Uveitis Steroid Treatment (MUST) Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 255
- 试验地点
- 23
- 主要终点
- Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis
研究概览
简要总结
The purpose of this study is to compare the effectiveness of standardized systemic therapy versus fluocinolone acetonide implant therapy for the treatment of severe cases of non-infectious intermediate uveitis, posterior uveitis, or panuveitis.
详细描述
The MUST trial is a randomized controlled clinical trial comparing two treatments for patients with vision-threatening non-infectious intermediate uveitis, posterior uveitis, or panuveitis:
- local therapy with fluocinolone acetonide intraocular implant in affected eyes; versus
- standard therapy: systemic corticosteroid therapy supplemented, when indicated, by corticosteroid-sparing potent immuno-modulator therapy.
Study ophthalmologists, clinic coordinators, and patients will not be masked to treatment assignment. Masking will be applied to the determination of visual function at baseline, the six month visit, and thereafter . Patients will be followed until death, participant withdrawal, or a common study closeout. Patients will be seen at baseline, one month after randomization, three months after randomization, and every three months thereafter for data collection. Both ophthalmological and medical data will be collected to evaluate the outcomes of treatment of the uveitis, complications of the uveitis, and complications from therapy itself. Selected laboratory data related to the complications from systemic corticosteroid therapy will be collected.
The planned sample size of 250 patients, 125 per treatment group, is expected to give sufficient power to detect clinically important differences in visual acuity outcomes. Patients meeting the eligibility criteria detailed above will be enrolled at approximately 23 clinical centers in the United States, Australia and UK. Patients will be randomized on a 1:1 basis to one of the two treatment groups.
The MUST Research Group received additional funding at the completion of the MUST Trial to continue following patients enrolled in the study for an additional 7 years in the MUST Trial Follow-up Study (MUST FS). Since uveitis is often a chronic condition requiring long-term treatment, the objectives of the MUST FS are to evaluate outcomes of the two treatments over a longer period time. The outcomes specified for MUST FS are the same as those specified for the MUST Trial: visual acuity, ocular and systemic side effects of treatment, quality of life, and control of ocular inflammation. The primary analyses will be to compare outcomes between the original randomization groups, i.e., intention-to-treat. Secondary analyses will be based on treatment received. Study visits will be conducted every 6 months in MUST FS as opposed to every 3 months in the MUST Trial. Two analyses are planned for public release, one at 4.5 years and one after 7 years of follow-up. The Data Safety Monitoring Board reviewed and approved the analysis plan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 13 years or older
- •Best-corrected visual acuity of hand motions or better in at least one eye with uveitis
- •Intraocular pressure 24 mm Hg or less in all eyes with uveitis
排除标准
- •Inadequately controlled diabetes
- •Uncontrolled glaucoma
- •Advanced glaucomatous optic nerve injury
- •A history of scleritis; presence of an ocular toxoplasmosis scar.
- •HIV infection or other immunodeficiency disease for which corticosteroid therapy would be contraindicated according to best medical judgment
研究组 & 干预措施
1
Immunosuppressant medication implant
干预措施: fluocinolone acetonide intraocular implant (Drug)
2
Systemic corticosteroids with immunosuppressant drugs as needed
干预措施: oral corticosteroid with immunosuppressive agents as needed (Drug)
结局指标
主要结局
Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis
时间窗: 24 months
Best-corrected visual acuity was measured as the number of letters read from standard logarithmic visual acuity charts by study-certified examiners who were masked to treatment. Visual acuity was measured at all study visits. The primary outcome was eye-specific change in visual acuity from baseline to 2-year follow-up. Positive change values indicate improved vision while negative change values indicate vision has gotten worse. A change of 7.5 letters is considered clinically meaningful.
次要结局
- Hypertension Diagnosis Requiring Treatment(24 months)
- Diabetes Mellitus(24 months)
- Mortality(24 months)
- Macular Edema(24 months)
- Intraocular Pressure - Incident IOP Greater Than or Equal to 30 mm Hg(24 months)
- Uveitis Activity(24 months)
- Intraocular Pressure - Incident IOP Greater Than or Equal to 24 mm Hg(24 months)
- Intraocular Pressure - Incident IOP Elevation >= 10 mmHg Above Baseline(24 months)
- Glaucoma - Incident(24 months)
- Intraocular Pressure (IOP) - Incident Use of IOP-lowering Medical Therapy (Percentage of Eyes With Uveitis That Were Not Being Treated With IOP-lowering Medical Therapy at Baseline and Underwent IOP Lowering Therapy During the 24 Month Follow-up.(24 months)
- Intraocular Pressure - IOP-lowering Surgery(24 months)
- Cataract - Incident Cataract(24 months)
- Change in Self-reported Vision-related Function as Measured by the National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ 25) Vision Targeted Composite Score From Baseline to 24 Months(24 months)
- Change in SF-36 Mental Component Score From Baseline to 24 Months(24 months)
- Change in SF-36 Physical Component Score From Baseline to 24 Months(24 months)
- Hyperlipidemia - Incident(24 months)