EUCTR2010-022128-63-GB进行中（未招募）1 期
A Multi-center, Double-Masked, Parallel Group, Placebo-Controlled Study to Assess the Efficacy and Safety of Voclosporin as Therapy in Subjects with Active Non-Infectious Intermediate, Posterior or Pan-uveitis - A MC study to assess Efficacy and Safety of Voclosporin in Panuveitis
ux Biosciences, Inc.0 个研究点目标入组 180 人开始时间: 2010年12月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •I.1.Active noninfectious uveitis involving the intermediate and/or posterior segment (anterior + intermediate-, intermediate-, posterior- or pan-uveitis) in at least one eye as evidenced by a vitreous haze grade of at least 2+ at Baseline visit (Visit 1).
- •I.2.Uveitis therapy
- •Current therapy must conform to one of the following:
- •-Prednisone monotherapy at a dose of = 10 mg/day and = 40 mg/day (or equivalent) for at least 2 weeks prior to baseline visit (Visit 1)
- •-Prednisone, at any dose, in addition to one immunomodulatory agent from among cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate for at least 2 weeks prior to baseline visit (Visit 1)
- •-N.B.: All immunosuppressive therapy (excluding systemic corticosteroids) must be discontinued by the evening prior to the baseline visit (Visit 1).
- •I.3.Considered by the Investigator to require systemic immunosuppressive therapy
- •I.4.A minimum ability to count fingers at a distance of 30 cm (1 foot) in both eyes
- •I.5.At least 18 years of age
- •I.6.Subjects, whether male or female, with reproductive potential and who are sexually active must agree to use double-barrier contraception methods throughout the course of the study (minimum of 24 weeks)
- •I.7.Women of childbearing potential must have a negative urine pregnancy test (UPT) within 48 hours prior to starting study drug. All female subjects (including those with tubal ligations) will be considered to be of childbearing potential unless one or more of the following criteria are met:
- •-Over the age of 60 years
- •-Amenorrheic for at least 2 years if age 45-60 years
- •-Have had a hysterectomy and/or bilateral oophorectomy
- •I.8.Subjects must be:
- •-Capable of understanding the purpose and risks of the study
- •-Able to give written informed consent
- •-Able to comply with all study requirements
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •E1.1.Uveitis limited to only the anterior segment in the study eye
- •E1.2.Confirmed or suspected infectious uveitis in either eye, including but not limited to infectious uveitis due to tuberculosis, cytomegalovirus, Lyme disease, toxoplasmosis, Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipples disease, herpes zoster virus (HZV) and herpes simplex virus (HSV) or history of other ocular herpetic infection
- •E1.3.Presence of an ocular toxoplasmosis scar or suspected active infection in either eye
- •E1.4.Active infection (i.e. bacterial, viral, parasitic or fungal) in either eye
- •E1.5.Serpiginous choroidopathy in either eye
- •E1.6.Active inflammatory lesions or vasculitis involving the central macula in either eye
- •E1.7.History of central serous chorioretinopathy in either eye
- •E1.8.Proliferative or severe non-proliferative diabetic retinopathy in either eye
- •E1.9.Neovascular/wet age-related macular degeneration in either eye
- •E1.10.Abnormality of vitreoretinal interface (i.e., vitreomacular traction, epiretinal membranes, etc.) thought by the Investigator to interfere with measurement of macular thickness or with the potential for macular structural damage independent of the inflammatory process in the study eye
- •E1.11.Clinically suspected or confirmed ocular or central nervous system lymphoma
- •E1.12.Lens opacities or obscured ocular media in the study eye (refer to section 8.1 for definition of the study eye) at baseline (Visit 1) such that reliable evaluations and grading of either the intermediate or posterior segment cannot be performed
- •E1.13.Any other ocular disease in the study eye that can interfere with the diagnosis or assessment of disease progression
- •E1.14.Monocular [anophthalmic fellow eye]
- •E1.15.Intraocular pressure of >21 mmHg in either eye
- •E1.16.Chronic hypotony (intraocular pressure less than 6 mmHg or clinical signs such as choroidals, choroidal or corneal folds) or pre-phthisical state (e.g., sclera thickening on ultrasonography, decreasing globe size) in either eye
- •E1.17.Contraindication to pupil dilation in either eye
- •E1.18.Unwillingness to defer elective ocular surgery (e.g., cataract extraction) until after completion of study participation in the study eye.
- •E2. Specific Prior and Current Treatments (for details please refer to protocol)
- •E3. Specific Extra-ocular Conditions (for details please refer to protocol)
- •E4. Specific Laboratory, Blood Pressure and ECG Evaluations (for details please refer to protocol)
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