LUMINA: A Phase III, Multicenter, Sham-Controlled, Randomized, Double-Masked Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Santen Inc.
- 入组人数
- 145
- 试验地点
- 65
- 主要终点
- Vitreous Haze (VH) of Zero Response at Month 5
研究概览
简要总结
This is a Phase III study to assess the efficacy and safety of DE-109 440 µg every 2 months in subjects with active, non-infectious uveitis of the posterior segment of the eye (NIU-PS).
There is a 6-month, single-arm, open-label period after completion of the 6-month double- masked, controlled period allows the evaluation of the efficacy and safety of intravitreal injection of DE-109 440 µg every 2 months for longer duration than appropriate for a placebo or sham control.
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
- •Non-Infectious Active Uveitis of the Posterior Segment
排除标准
- •Females who are pregnant, nursing, or planning a pregnancy Confirmed or suspected infectious uveitis
研究组 & 干预措施
Test Arm: DE-109 Injectable Solution
Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4).
干预措施: DE-109 Intravitreal Injections (Drug)
Control Arm: Sham Procedure
Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye.
干预措施: Sham Procedure (Other)
Dummy Arm: DE-109 Injectable Solution
Dummy Arm: Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4).
干预措施: DE-109 Intravitreal Injections (Drug)
Open-label:DE-109 Injectable Solution
Subjects completing the Month 6 pre-dose evaluations (the final evaluations in the double-masked period) began the open-label period of the study, in which all subjects received intravitreal injection of DE-109 440 μg in the study eye(s) every 2 months for an additional 6 months of dosing.
干预措施: DE-109 Intravitreal Injections (Open Label) (Drug)
结局指标
主要结局
Vitreous Haze (VH) of Zero Response at Month 5
时间窗: Month 5
Vitreous Haze (VH) was assessed during slit-lamp biomicroscopy and scored using the modified Standardized Uveitis Nomenclature (SUN) scale as follows: * Score = 0: No inflammation * Score = 0.5+: Trace inflammation (slight blurring if the optic disc margins and/or loss of nerve fiber layer reflex) * Score = 1+: Mild blurring of the retinal vessels and optic nerve * Score = 1.5+: Optic nerve had and posterior retina view obstruction greater than 1+ but less than 2+ * Score = 2+: Moderate blurring of the optic nerve head * Score = 3+: Marked blurring of the optic nerve head * Score = 4+: Optic nerve head not visible VH 0 response (resolution of inflammation) is defined as a VH score of 0 in the study eye at a specified follow up visit based on the modified SUN scale. The response as a percentage is calculated as the proportion of study eyes which achieved a VH score of zero at Month 5
次要结局
- Mean Composite Score at Month 3 and Month 5(Month 3, Month 5)
- Vitreous Haze (VH) of Zero Response at Month 3(Month 3)