Evaluation of the Effects of Oral QLT091001 in Adults With Impaired Dark Adaptation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- QLT Inc.
- 入组人数
- 43
- 试验地点
- 7
- 主要终点
- Visual Acuity
研究概览
简要总结
This is a Phase IIa proof-of-concept study to evaluate the effects of oral QLT091001 on adults with impaired dark adaptation.
详细描述
This proof-of-concept study is a randomized, parallel design of two different oral doses of QLT091001 compared to placebo to evaluate treatment effects in patients with impaired dark adaptation.
Approximately 40 subjects will be enrolled in this study at approximately 7 centers in the US.
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
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects ≥60 yrs with early age-related macular degeneration (AMD) based on LLLC BCVA criterion or evidence of impaired dark adaptation
- •Subjects with high luminance high contrast best-corrected visual acuity (HLHC BCVA) of 40 letters (20/40 Snellen) or better in the study eye
- •Capable and willing to provide consent
排除标准
- •Women of child bearing potential
- •Subjects with late AMD or any other optic neuropathy in the study eye
- •Subjects with posterior subcapsular cataract or multifocal intra-ocular lens (IOL) in the study eye
- •Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 60 days of Day 0 or who have taken any prescription/investigational oral retinoid medication within 6 months of Day 0
- •Subjects taking age-related eye disease study (AREDS) supplements containing beta-carotene
研究组 & 干预措施
Placebo (for QLT091001)
Placebo is supplied to mimic QLT091001 oral solution.
干预措施: Placebo (Other)
QLT091001 - first oral dose
Subjects will receive an oral dose of 10mg/m2 of QLT091001.
干预措施: QLT091001 (Drug)
QLT091001 - second oral dose
Subjects will receive an oral dose of 40 mg/m2 of QLT091001.
干预措施: QLT091001 (Drug)
结局指标
主要结局
Visual Acuity
时间窗: Through 7 weeks
Low luminance low contrast best-corrected visual acuity (LLLC BCVA) will be measured at multiple time points.
次要结局
- Dark Adaptation Time(Through 7 weeks)