Phase IIA Double-Masked Randomized Sham-Controlled Trial of QPI-1007 Delivered by a Single Intravitreal Injection to Subjects With Acute Primary Angle-Closure Glaucoma (APACG)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 8
- 主要终点
- Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluation intraocular pressure (IOP)
研究概览
简要总结
This study will assess any side effects that may occur when QPI-1007 is injected into the eye in subjects with acute primary angle-closure glaucoma, as well as how long it takes for the body to clear the drug. This study will also test whether QPI-1007, injected into the eye, helps prevent both structural damage of the nerve tissue in the eye and the loss of visual function in subjects with acute primary angle-closure glaucoma.
详细描述
This is a Phase IIa double-masked, single dose, randomized, sham-controlled study evaluating the safety and tolerability, and pharmacokinetics of QPI-1007 versus Control (sham procedure) in subjects with an acute attack of primary angle-closure glaucoma.
Subjects will be randomized at a ratio of 1:1 into one of two study arms: 1.5 QPI-1007 arm or Control arm (sham procedure). The study will enroll approximately 30 subjects into each arm. Randomization will be stratified by time from symptom onset to the study drug administration or sham procedure (≤72 hours and >72 hours).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged at least 40 years or older.
- •Onset of symptoms of an acute attack of primary angle-closure in the study eye within the 120 hours prior to the planned study drug administration.
- •Best-corrected visual acuity (BCVA) 20/40 or better in the study eye after resolution of the acute attack.
- •Received successful treatment for the acute attack of angle-closure, and have undergone laser iridotomy with intraocular pressure in the study eye <25mm Hg.
- •Sufficiently clear ocular media and adequate pupil dilation to allow the optic nerve and fovea to be visualized and assessed in the study eye.
- •Female subjects must be: (1) post menopausal, (2) surgically sterile, or (3) using an effective means of contraception.
排除标准
- •Previously diagnosed with glaucoma in either eye.
- •The time planned for study drug administration is more than 120 hours from the onset of the symptoms.
- •History of chronic angle-closure in either eye.
- •Secondary angle-closure/secondary angle-closure glaucoma in the study eye.
- •Monocular subjects.
- •Prior incisional intraocular surgery.
- •Inability to perform a reliable visual field test on Day 0 in the study eye.
- •History of panretinal photocoagulation or macular laser photocoagulation in the study eye.
- •History of active malignancy within the last 5 years (however, non facial, basal cell carcinoma is allowed).
- •History of myocardial infarction within the last 6 months.
- •Received any drugs known to cause optic nerve or retinal toxicity within 14 days prior to dosing.
- •Women who are pregnant or lactating.
- •Participating in a concurrent interventional study with the last intervention occurring within 30 days prior to planned dosing with QPI-1007.
研究组 & 干预措施
QPI-1007 Injection
single intravitreal (IVT) injection of QPI-1007
干预措施: QPI-1007 Injection (Drug)
Control
Placebo (Sham injection procedure)
干预措施: (including placebo) (Drug)
结局指标
主要结局
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluation intraocular pressure (IOP)
时间窗: Screening, Days 0 (before injection, both eyes; after injection study eye only), 1 and 7, and Month 1 to 6
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by vital signs and weight
时间窗: Weight: Screening and Month 4; Vital signs: Screening, Days 0 (before injection), 1 and 7, and Month 4 to 6
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluations, Visual Field (VF) and Spectral Domain Optical Coherence Tomography (SD-OCT)
时间窗: Days 0 and 7, and Month 1 to 6
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluations optic nerve head stereo photographs and contrast sensitivity
时间窗: Days 0 and 7, and Month 4 and 6
Safety and tolerability of a single intravitreal (IVT) dose of QPI-1007 as assessed by adverse events (AE)
时间窗: Day 0 (after injection) through Month 4. Systemic serious AEs (SAEs) assessed as related to study drug and all ocular SAEs Month 4 to Month 6 after injection
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluations, Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (EDTRS) chart and slit lamp exams (anterior & posterior segment)
时间窗: Screening, Days 0, 1 and 7, and Month 1 to 6
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluation, Fundus Photographs (FP)
时间窗: Days 0 and 7, and Month 4
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by laboratory evaluations
时间窗: Screening, Day 1, and Month 4 after injection
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by use of concomitant treatments
时间窗: Days 0, 1 and 7, and Month 1 to 6
次要结局
- Difference between QPI-1007 and control group (sham) as assessed by change in the mean BCVA using the EDTRS chart compared to baseline(4 months after injection)
- Difference between QPI-1007 and control group (sham) as assessed by progression of the visual fields compared to baseline(4 months after injection)
- QPI-1007 pharmacokinetics (PK) parameters as assessed by the peak plasma concentration (Cmax)(Pre-injection, 1, 4 and 24 hours after injection, and 7 days after injection)
- Difference between QPI-1007 and control group (sham) as assessed by SD-OCT parameters(4 months after injection)
- Difference between QPI-1007 and control group (sham) as assessed by the prevalence of the abnormal visual fields(4 months after injection)
- Difference between QPI-1007 and control group (sham) as assessed by change in the mean contrast sensitivity compared to baseline(4 months after injection)
- QPI-1007 pharmacokinetics (PK) parameters as assessed by the time to peak plasma concentration (Tmax)(Pre-injection, 1, 4 and 24 hours after injection, and 7 days after injection)
- Difference between QPI-1007 and control group (sham) as assessed by change in the mean deviation compared to baseline(4 months after injection)