CTRI/2009/091/000898已完成3 期
A 24-week multicenter, randomized, double-masked, placebo controlled, dose-ranging phase III study of AIN457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression in patients with quiescent, non-infectious intermediate, posterior or panuveitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 7
- 主要终点
- * Recurrence of active intermediate, posterior, or panuveitis defined by either: greater than or equal to 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity of greater than or equal to 10 ETDRS letters
研究概览
简要总结
Target number of patients from India is 48.Planned FPFV is 8th June 2010.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with quiescent chronic, non-infectious intermediate uveitis, posterior uveitis or panuveitis as evidenced by less than 1+ anterior chamber cell grade and less than 1+ vitreous haze in both eyes for at least 6 weeks prior to screening.
- •Requirement for either of the following immunosuppressive therapies at any time within the past 3 months for the treatment or prevention of uveitis which must not have been increased within the 6 weeks prior to screening: Prednisone or equivalent greater than or equal to 10 mg daily.
- •greater than or equal to 1 periocular injection or greater than or equal to 1 intravitreal corticosteroid injection (i.e. triamcinolone) in the study eye within the past 6 months (the last injection must not have been given 6 weeks prior to screening.) Treatment with either cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate as monotherapy or in combination with or without steroids.
- •(Patients treated with chlorambucil or cyclophosphamide within the past 5 years are ineligible for the study.) Patients not meeting the above specified criteria for immunosuppressive therapies are eligible for enrollment if they are intolerant to systemic immunosuppressive therapy as determined by the study investigator.
排除标准
- •Ocular concomitant conditions/disease* Patients with a primary diagnosis of Behcet's disease, anterior uveitis or any intermediate uveitis, posterior uveitis or panuveitis in which the manifestation(s) of the active intraocular inflammatory disease may spontaneously resolve or that are not characterized by the presence of either anterior chamber cells or vitritis (vitreous cell and haze) such as the white dot retino-choroidopathies (i.e. Punctate inner choroidopathy (PIC), acute zonal occult outer retinopathy (AZOOR.) * Patients with active, non-infectious intermediate, posterior or panuveitis in one or both eyes (greater than or equal to 1+ anterior chamber cells and /or greater than or equal to 1+ vitreous haze.) * Patients receiving or that may require corticosteroids (prednisone or equivalent) greater than or equal to 1 mg/kg/day to maintain quiescence of their intraocular inflammation.
- •Ocular treatments* Treatment with intravitreal anti-VEGF agents administered to the study eye within 3 months prior to screening.
- •* Treatment with fluocinolone acetonide implant (Retisert®) in the study eye within the last 3 years, or dexamethasone intravitreal implant and any other investigational corticosteroid implants in the study eye within the last 6 months.
- •* Intraocular surgery or laser photocoagulation in the study eye within the last 6 weeks prior to screening except for a diagnostic vitreous or aqueous tap with a small-gauge needle.
- •Systemic conditions or treatments* Any systemic biologic therapy (e.g. interferon, infliximab, daclizumab, etanercept, or adalimumab) given intravenously or subcutaneously within 3 months prior to screening.
- •No biologic therapy other than the investigational study treatment will be allowed during the course of the clinical trial.
- •* Any prior treatment with systemic alkylating agents (cyclophosphamide, chlorambucil) within the past 5 years prior to screening.
- •* Treatment with any live or live-attenuated vaccine (including vaccine for varicella-zoster or measles) within 2 months prior to screening.
- •No treatment with live or live-attenuated vaccines will be allowed during the course of the clinical trial.
结局指标
主要结局
* Recurrence of active intermediate, posterior, or panuveitis defined by either: greater than or equal to 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity of greater than or equal to 10 ETDRS letters
时间窗: after baseline
次要结局
- * Change in immunosuppressive medication score from baseline to 24 weeks(Baseline to 24 weeks)
- * Mean time to recurrence of active intermediate, posterior, or panuveitis from baseline(Baseline to 24 weeks)
- * Mean change in best corrected visual acuity from baseline(Baseline to 24 weeks)
- * Mean change in vitreous haze grade and anterior chamber cell grade from baseline to 24 weeks(Baseline to 24 weeks)
- * Change from baseline in Quality of Life/Patient reported outcome assessments(Baseline to 24 weeks)
研究者
研究点 (7)
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