Efalizumab to Treat Uveitis
关键词
抽象
描述
Background: Uveitis refers to intraocular inflammatory diseases that are an important cause of visual loss. Standard systemic immunosuppressive medications for uveitis can cause significant adverse effects. Consequently, an effective treatment with a safer side effect profile is highly desirable.
Aims: This protocol evaluated the safety and potential efficacy of subcutaneous (SC) efalizumab (anti-CD11a) treatments for uveitis while reducing or eliminating standard medications commensurate with the standard of care. If the therapeutic benefit was sustained using the SC formulation, then maintenance therapy was continued as clinically indicated.
Methods: This was an open-label, non-randomized, clinical pilot study.
日期
最后验证: | 12/31/2010 |
首次提交: | 01/20/2006 |
提交的预估入学人数: | 01/19/2006 |
首次发布: | 01/22/2006 |
上次提交的更新: | 01/27/2011 |
最近更新发布: | 02/01/2011 |
首次提交结果的日期: | 07/14/2010 |
首次提交质量检查结果的日期: | 01/04/2011 |
首次发布结果的日期: | 01/26/2011 |
实际学习开始日期: | 12/31/2005 |
预计主要完成日期: | 01/31/2009 |
预计完成日期: | 01/31/2009 |
状况或疾病
干预/治疗
Drug: Efalizumab
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: Efalizumab | Drug: Efalizumab Participants who qualified for the study received weekly subcutaneous treatments of efalizumab, with the first dose being a test dose of 0.7 mg/kg and subsequent doses of 1 mg/kg (not to exceed 200 mg per dose), for a total treatment duration of 16 weeks. |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - Participant is 18 years of age or older; - Participant has a diagnosis of sight-threatening, intermediate or posterior uveitis of at least three months duration prior to original enrollment that is causing persistent cystoid macular edema in one or both eyes. Their disease requires treatment to control their intraocular inflammatory disease with at least 20 mg/day of prednisone (or equivalent) or any combination of two or more anti-inflammatory treatments for uveitis, including for example prednisone, cyclophosphamide, cyclosporine, azathioprine, mycophenolate mofetil, methotrexate, etc. - Participant exhibits intolerance to the indicated systemic medications required for their uveitis or, though their uveitis may be under control, wish to be taken off their present medications due to potential or actual unacceptable side effects. - Participant has visual acuity in at least one eye of 20/200 or better. - Participant has normal renal or liver function or no worse than mild abnormalities as defined by the Common Toxicity Criteria. - Participant is not currently pregnant or lactating. - Both men and women with reproductive potential and who are sexually active agree to use acceptable birth control methods throughout the course of the study and for six weeks following the last administration of the study medication. - Participant must have the ability to understand and sign an informed consent form. Exclusion Criteria: - Participants who had received previous treatment with an intercellular adhesion molecule (ICAM) or lymphocyte function-associated antigen-1 (LFA-1) directed monoclonal antibody or any other investigational agent that would interfere with the ability to evaluate the safety, efficacy or pharmacokinetics of efalizumab. - Participant has a significant active infection. - Participant has a history of cancer (other than a non-melanoma skin cancer) diagnosed within the past 5 years. |
结果
主要结果指标
1. Number of Participants With Systemic Toxicities, Adverse Events, or Infections [16 weeks]
次要成果指标
1. Cystoid Macular Edema in the Worse Eye as Assessed by Optical Coherence Tomography (OCT). [Baseline and 16 weeks]
2. Cystoid Macular Edema in the Better Eye as Assessed by Optical Coherence Tomography (OCT). [Baseline and 16 weeks]
3. Change in Visual Acuity in the Worse Eye From Baseline to 16 Weeks [Baseline and 16 weeks]
4. Change in Visual Acuity in the Better Eye From Baseline to 16 Weeks [Baseline and 16 weeks]