Adrenocorticotrophic Hormone (ACTH) for the Treatment of Sarcoid Uveitis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Degree of aqueous and vitreous inflammatory cells-change is being assessed
研究概览
简要总结
Sarcoidosis is a multisystem granulomatous disease that can affect nearly any organ in the body. While most commonly affecting the lungs, vision threatening eye involvement occurs in approximately 25% of patients with sarcoid. Eye involvement may lead to a chronic, sight-threatening uveitis which may result in cataract, glaucoma, and macular edema. The treatment of sarcoid uveitis involves the use of topical and systemic corticosteroids or potent immunosuppressive agents (medications that suppress the body's immune system) both of which can cause severe long-term side effects. The adverse effects of steroids may be avoided by treatment with the use as H.P. Acthar® Gel. The effectiveness of H.P. Acthar® Gel in the treatment of sarcoid uveitis and patient quality of live have not been previously examined. These issues, will be explored in this research.
详细描述
The Investigator seeks to determine the efficacy of H.P. Acthar® Gel (40 units twice weekly injection) of on disease activity and severity in patients with sarcoid uveitis. The retrospective study will evaluate a series of quantitative outcome measures:
The degree of aqueous and vitreous inflammatory cells as graded by the criteria established by the Standardization of Uveitis Nomenclature (SUN) criteria at intervals of 0 weeks, 3 weeks, 6 weeks, 12 weeks and 24 weeks.
The degree of aqueous flare as graded by the criteria established by the Standardization of Uveitis Nomenclature (SUN) criteria at intervals of 0 weeks, 4 weeks,12 weeks and 24 weeks.
Best Corrected Visual Acuity at intervals of 0 weeks, 4 weeks, 12 weeks and 24 weeks.
Central Macular Thickness at intervals of 0 weeks, 4 weeks, 12 weeks and 24 weeks as measured by Optical Coherence Tomography (OCT).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of Sarcoid Uveitis as determined by
- •clinical exam
- •fluorescence angiography
- •optical coherence tomography
排除标准
- •Presence of long acting intraocular depots
- •Women of childbearing age not using contraceptives
研究组 & 干预措施
Treatment
The study intervention is the observation of study subjects who have received H.P. Acthar® Gel (adrenocorticotrophic hormone), 40 units twice weekly injections in patients who have sarcoid uveitis and to assess it's effectiveness by measuring changes the degree of aqueous and vitreous inflammatory cells present, the degree of aqueous flare, and changes in visual acuity, macular thickness, intraocular pressure and quality of life measures assessed by using the National Eye Institute Visual Function Questionnaires (VFQ-25)
干预措施: H.P. Acthar gel (Drug)
结局指标
主要结局
Degree of aqueous and vitreous inflammatory cells-change is being assessed
时间窗: 0 weeks, 4 weeks, 12 weeks and 24 weeks.
Degree of aqueous and vitreous inflammatory cells as graded by the criteria established by the Standardization of Uveitis Nomenclature (SUN)
次要结局
- Degree of aqueous flare- change is being assessed(0 weeks, 4 weeks 12 weeks and 24 weeks)
- Central macular thickness- change is being assessed(0 weeks, 4 weeks, 12 weeks and 24 weeks)
- Quality of life assessment- change is being assessed(0 weeks, 4 weeks, 12 weeks and 24 weeks)
- Intraocular pressure(0 weeks, 4 weeks, 12 weeks and 24 weeks)
- Visual acuity- change is being assessed(0 weeks, 4 weeks, 12 weeks and 24 weeks)
研究者
John Huang, MD
MD ophthalmologist
New England Retina Associates