Pharmacokinetics of the Brimonidine Tartrate Posterior Segment Delivery System in Patients Undergoing Pars Plana Vitrectomy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 24
- 主要终点
- Highest Vitreous Humor Level of Brimonidine in the Study Eye
研究概览
简要总结
This study will evaluate the pharmacokinetics of brimonidine following a single intravitreal administration of the 200 ug or 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery System in patients 2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Plan on having a pars plana vitrectomy for repair of a posterior segment condition (eg, epiretinal membrane, macular hole, vitreomacular traction)
- •Visual acuity in the non-study eye better than 20/200
排除标准
- •History of pars plana vitrectomy or retinal detachment surgery in the study eye
- •Surgery or laser treatment in the study eye within 3 months
- •Use of brimonidine, apraclonidine or other topical alpha-2-agonist in either eye within 2 weeks
- •Intraocular infection or inflammation
研究组 & 干预措施
400 µg Brimonidine Tartrate Implant
400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
干预措施: 400 µg Brimonidine Tartrate Implant (Drug)
200 µg Brimonidine Tartrate Implant
200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
干预措施: 200 µg Brimonidine Tartrate Implant (Drug)
结局指标
主要结局
Highest Vitreous Humor Level of Brimonidine in the Study Eye
时间窗: 60 Days
The highest level of brimonidine measured in the vitreous humor of the study eye in any patient is reported for each treatment arm. The vitreous humor is the clear gel that fills the space between the lens and the retina of the eye.
次要结局
- Highest Aqueous Humor Level of Brimonidine in the Study Eye(60 Days)
- Percentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ)(60 Days)