A Monocentric, Randomized, Controlled Trial to Test the Efficacy of Interferon-beta in the Treatment of Disseminated Encephalomyelitis (ED)-Associated and Primary Intermediate Uveitis in Comparison to Standard Treatment (TEAM)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change in visual acuity (3 lines ETDRS)at month 1,3,6 and 12
研究概览
简要总结
The purpose of this study is to investigate if interferon beta is superior to the standard treatment with Methotrexate for the treatment of intermediate uveitis and macular edema.
详细描述
Deuter et al were the first to show the anti-edematous effect of interferon alpha on inflammatory macular edema (Deuter C. M. E., Kötter I., Günaydin I., Zierhut M. Treatment of the Cystoid Macular Oedema in Behçet's Disease with Interferon Alfa-2a, Retina, in press). In an interventional, multi-centric pilot-study we could demonstrate a positive effect of interferon beta on ED associated uveitis, especially in reducing the macular edema. Undesired effects of the treatment were not observed.
Thus we want to test the efficacy and safety of interferon beta compared to standard treatment with methotrexate in a prospective, clinically controlled trial on patients who suffer from intermediate uveitis with inflammatory macular edema who either have associated ED or have no systemic disease association, i.e. primary uveitis. .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients age 18 and over
- •Active uni- or bilateral non-infectious intermediate uveitis of at least 1 year duration
- •Visual acuity on the worse eye at least 0.1 (20/200) and maximally 0.6 (20/30) caused by macular edema, defined by foveal thickness ≥ 250 µm
- •Either primary uveitis or diagnosis of Multiple Sclerosis
- •Previous treatment with oral corticosteroids in a dose of 0.5 mg per kg bodyweight of prednisone equivalent without sufficient success
- •Previous treatment with other immunosuppressive drugs is facultative
排除标准
- •Exclusively anterior uveitis
- •Absence of macular edema
- •Optic nerve atrophy after neuritis nervi optici
- •Peri-or intraocular injection of corticosteroids in the previous 3 months
- •Allergies against any interferon
- •Depression diagnosed by a psychiatrist
- •Hepatic disease
- •Infectious Uveitis
- •Other auto-immune diseases but MS
- •Pregnancy, Lactation
- •Lack of reliable contraception
- •Patients with metabolic, psychiatric or neoplastic diseases
- •Active diseases like asthma, psoriasis or inflammatory bowel disease who have to be treated with corticosteroids
- •primary or secondary immune deficiency
- •Tuberculosis or other infectious lung diseases
- •Hepatitis B or C
- •Life vaccination during the trial duration
研究组 & 干预措施
1
Interferon beta 3x weekly
干预措施: Interferon beta (Drug)
2
Methotrexate sc 20 mg weekly
干预措施: Methotrexate (Drug)
结局指标
主要结局
Change in visual acuity (3 lines ETDRS)at month 1,3,6 and 12
时间窗: at month 1,3,6 and 12
次要结局
- Reduction of macular edema (OCT)(at month 1,3,6 and 12)
- Reduction intraocular inflammation (2 step change, SUN classification)(at month 1,3,6 and 12)
- Increase in retinal light sensitivity (fundus controlled perimetry)(at month 1,3 and 12)
研究者
Friederike Mackensen
PD Dr. med.
Heidelberg University