A Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 Delivered By Single or Multi-Dose Intravitreal Injection(s) to Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 732
- 试验地点
- 83
- 主要终点
- Effect of QPI-1007 as assessed by Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
This study will determine the effect of QPI-1007 on visual function in subjects with recent-onset NAION and assess the safety and tolerability of intravitreal injections of QPI-1007 in this population. This study will also evaluate the structural changes in the retina following administration of QPI-1007.
详细描述
This is a double masked, randomized, sham-controlled efficacy and safety study that will enroll approximately 800 subjects with recent-onset NAION. Subjects will be randomized into one of 3 groups in a 1:1:1 ratio, and assigned to receive QPI-1007 and/or a sham procedure. Subjects will have a two in three (66%) chance of receiving active treatment (no sham procedure) and a one in three (33%) chance of receiving sham procedure (no active treatment). Total study time involvement is approximately 12 months.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive diagnosis of first episode of NAION in the study eye with symptom onset within 14 days prior to planned study drug administration/sham procedure
- •Best corrected visual acuity score in the study eye is better than or equal to 15 letter score, measured using the ETDRS visual acuity protocol at Day 1 prior to study drug administration/sham procedure.
- •Clear ocular media and able to undergo adequate pupil dilation to allow a good fundus examination
排除标准
- •Present use or history of any treatment for the current episode of NAION, including systemic steroids, brimonidine, or traditional Chinese herbal medicine
- •Prior episode of NAION in the study eye only
- •Present use of drugs known to cause optic nerve or retinal toxicity at Day 1/Randomization, such as: chloroquine or hydroxychloroquine, ethambutol, Vigabatrin. Subjects who need to be prescribed any of these drugs during the course of the study will be discontinued from the trial.
- •Any medical condition, concomitant therapy, or previous incisional or laser surgery that, in the opinion of the Investigator, would preclude IVT injection in the study eye only
- •Clinical evidence of temporal arteritis
研究组 & 干预措施
single dose or multiple dose
QPI-1007 Injection - 1.5 mg
干预措施: QPI-1007 Injection - 1.5 mg (Drug)
single or multiple dose
QPI-1007 Injection - 3.0 mg
干预措施: QPI-1007 Injection - 3.0 mg (Drug)
Sham
Sham injection procedure
干预措施: Sham Injection Procedure (Other)
结局指标
主要结局
Effect of QPI-1007 as assessed by Best Corrected Visual Acuity (BCVA)
时间窗: Baseline through Month 12
Safety and tolerability of QPI-1007 as assessed by adverse events (AE), laboratory evaluations, ECGs, ophthalmic evaluations, slit lamp anterior/posterior examinations, intraocular pressure measurements, presence/absence of vitreous inflammation
时间窗: Baseline through Month 12
次要结局
- Mean change in BCVA score, as measured by ETDRS visual acuity protocol in the study eye(Day 1 through Month 12)
- Mean change of Visual Fields, as assessed by Humphrey standard automated perimetry(Day 1 through Month 12)