NCT03066869Unknown4 期
Open-label, Single-center, Prospective Study on the Efficacy and Safety of Repository Corticotropin Injection (H.P. ACTHAR GEL) in the Treatment of Adults With Non-infectious Retinal Vasculitis
Ocular Immunology and Uveitis Foundation1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年3月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of responders to Acthar at the end of treatment.
研究概览
简要总结
The purpose of this study is to evaluate the short- and long-term efficacy and safety of Acthar for the treatment of adults with non-infectious retinal vasculitis.
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
- •Any adult patient with active retinal vasculitis (involving arteries or veins) as a manifestation of non-infectious ocular inflammatory disease; fundus must be viewable with wide-field FA in the study eye
- •If both eyes are involved, both are eligible for inclusion in the study
- •Patients already on non-steroidal immunosuppressive therapy may continue on this during the study, but the dose must not be increased or decreased within 6 weeks of initiating the trial
- •Willing and able to sign the informed consent form
排除标准
- •Patients under age 18
- •Patients who are pregnant (must be ruled out in women of child-bearing age)
- •Active infectious ocular or systemic disease
- •Patients with active infectious ocular or extraocular disease
- •Patients with history of malignancy, except for dermatologic entities of basal or squamous cell carcinoma which have been completely excised or removed previously
- •Patients with systemic illness involving abnormalities of the hypothalamic-pituitary-adrenal axis; patients with primary adrenocortical insufficiency or adrenocortical hyperfunction
- •Patients with known hypersensitivity to Acthar
- •Patients on other non-steroidal systemic immunomodulatory medications with dose adjusted sooner than 6 weeks prior to study drug administration
- •Patients currently on or recently treated with (within 6 weeks) systemic corticosteroid
- •Patients with periocular or intraocular injections of medications administered to help control inflammation sooner than 6 weeks prior to study drug administration
- •Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator, or contraindicated, including but not limited to, patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, or sensitivity to proteins of porcine origin. Administration of live or live attenuated vaccines is contraindicated in patients during the entire duration of the study and for one month prior
研究组 & 干预措施
H.P. ACTHAR GEL
Experimental
干预措施: H.P. ACTHAR GEL (Drug)
结局指标
主要结局
Percentage of responders to Acthar at the end of treatment.
时间窗: 24 Weeks
A responder will be defined by the binominal presence or absence of active retinal vasculitis as evaluated at Week 24. Active retinal vasculitis is defined as angiographic leakage from retinal arterioles, venules, or capillaries as determined by investigator, seen on wide-field angiography. Complete resolution or absence of active retinal vasculitis at Week 24 is considered success or "remission".
次要结局
- Safety assessments, including drug tolerability and adverse events; other ocular and/or systemic complications.(1 Day to 24 Weeks)
- Percentage of patients requiring rescue therapy.(1 Day to 24 Weeks)
- Presence or absence of active retinal vasculitis at all other time points.(1 Day to 24 Weeks)
研究者
研究点 (1)
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