Efficacy of Repository Corticotropin Injection in Patients With Severe and Recalcitrant Keratoconjunctivitis Sicca
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Conjunctival hyperemia
研究概览
简要总结
The purpose of this pilot study is to assess repository corticotropin injection (RCI) in the form of H.P. Acthar Gel in patients with severe keratoconjunctivitis sicca (KCS, or dry eye disease). This pilot study is a non-randomized, open-label, interventional study to assess the efficacy and timeline of RCI for the treatment of severe KCS recalcitrant to conventional therapy. The purpose is to acquire preliminary data to support and guide the design of a future, double-masked, randomized, controlled clinical trial.
详细描述
This study is a non-randomized, open-label, interventional pilot study with sixteen weeks (112 days) of active treatment, a possible twelve-week treatment extension, and twenty-four weeks of washout follow-up. Intervention is with HP Acthar Gel dosed at 80 U BIW SC indicated for use in anterior segment disease and keratitis. Data will be collected from five subjects. All subjects will be treated with 80 U BIW SC and clinically examined at two, four, six, nine, twelve, and sixteen weeks with a potential extension of up to twenty-eight weeks. Extension will be contingent upon specific outcome criteria defined in this protocol. Four clinical visits will occur at two, four, eight, and twelve weeks after initiating the drug taper to assess for regression of the signs and symptoms of KCS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥ 18 years
- •Severe keratoconjunctivitis sicca (KCS) as defined by meeting at least three of the following in the same or both eye(s): (1) OSDI ≥ 33, (2) sum corneal staining with fluorescein of ≥ 5 in at least one eye, (3) MMP-9 concentration ≥ 40 ng/ml in at least one eye as measured by InflammaDry®, and (4) bulbar hyperemia of ≥ 2.0 in at least one eye as measured by the Oculus Keratograph® 5M
- •Recalcitrant or intolerant to treatment with cyclosporine 0.05% ophthalmic emulsion (Restasis®) or lifitegrast 5% ophthalmic solution (Xiidra®)
排除标准
- •Past or present history of: scleroderma, osteoporosis, systemic bacterial or fungal infection (including but not limited to tuberculosis), psychosis, ocular herpes simplex, peptic ulcer, congestive heart failure, diabetes mellitus, myasthenia gravis, hypothyroidism, liver cirrhosis, primary adrenocortical insufficiency or adrenocortical hyperfunction, central serous chorioretinopathy.
- •Any corticosteroid use within 60 days of study enrollment
- •Topical cyclosporine 0.05% ophthalmic emulsion (Restasis) or lifitegrast 5% ophthalmic solution (Xiidra) use within 60 days of study enrollment
- •Recent surgery within 90 days
- •Current uncontrolled, sustained hypertension
- •Post-prandial blood glucose value of ≥ 140 mg/dl as measured at the baseline visit
- •Sensitivity to proteins of porcine origin
- •Anticipated administration of live or live attenuated vaccines during the course of the study
- •Known sensitivity to steroid or complications from prior steroid use that subject is unwilling to tolerate
- •Pregnancy (as assessed by urine hCG) or nursing
- •Participation in a clinical trial involving a drug or device within the past 30 days
- •Investigator discretion based upon medical history and/or opinion of ability to maintain protocol compliance
研究组 & 干预措施
Treatment
Treated with repository corticotropin injection
干预措施: repository corticotropin injection (Drug)
结局指标
主要结局
Conjunctival hyperemia
时间窗: 16 weeks
Change from baseline in bulbar conjunctival hyperemia as measured by the Oculus Keratograph 5M
Corneal staining
时间窗: 16 weeks
Change from baseline in corneal staining with fluorescein
次要结局
- Tear cytokine concentration(16 weeks)
- Patient symptoms(16 weeks)
研究者
Jason Nichols
Principal Investigator
University of Alabama at Birmingham