NCT01358266已完成3 期
A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Santen Inc.
- 入组人数
- 592
- 主要终点
- The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Confirmed diagnosis of active uveitis
- •18 years of age or older
- •Sign informed consent
- •Meet best corrected ETDRS visual acuity
排除标准
- •Uveitis of infectious etiology
- •Suspected/confirmed central nervous system or ocular lymphoma
- •Primary diagnosis of anterior uveitis
- •Uncontrolled glaucoma
- •Use of topical oculary medication
- •Implanted device
- •Significant ocular disease
- •Lens/media opacities or obscured ocular media
- •Intraocular surgery or treatments
- •Capsulotomy
- •Ocular or periocular infection
- •Pupillary dilation
- •History of herpetic infection
- •Toxoplasmosis or toxoplasmosis scar
- •Ocular malignancy
- •Allergy or hypersensitivity to study drug
- •Participation in other uveitis trial within 30 days
- •Monoclonal antibody treatment or biologic therapy
- •Any systemic condition/infection
- •Immunosuppressive therapy or immunocompromised
- •Malignancy remission
- •Females who are pregnant or lactating and females not using adequate contraceptives
研究组 & 干预措施
Ophthalmic solution low dose
Active Comparator
干预措施: DE-109 44 ug (Drug)
Ophthalmic solution medium dose
Active Comparator
干预措施: DE-109 440 ug (Drug)
Ophthalmic solution high dose
Active Comparator
干预措施: DE-109 880 ug (Drug)
结局指标
主要结局
The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5
时间窗: Day1 (Baseline) and Month 5 (Day150)
At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0 = No inflammation
次要结局
- VH 0 or 2-unit Response: Having a Reduction (Improvement) of at Least 2 Units From Baseline in VH Score or a VH Score of 0 at Month 5 (Modified SUN Scale)(Day1/Baseline and Day150/Month 5)
- VH 0 or 0.5+ Response: Having a VH Score of 0 or 0.5+ at Month 5 (Modified SUN Scale)(Day1/Baseline and Day150/Month 5)
研究者
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