An Open-label Phase I Study to Evaluate the Safety, Tolerability and Biodegradation Period of PolyActiva PA5108 Ocular Implant When Administered Intracamerally to the Anterior Chamber of the Eye
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Safety and tolerability as measured by the occurrence of adverse events
研究概览
简要总结
A single centre, open label, study to assess the safety, tolerability and biodegradation of PA5108 ocular implant in adults who have Open Angle Glaucoma (Primary or Secondary).
详细描述
Participants who are currently managing their Open Angle Glaucoma with combination drop therapy will be recruited. Drop therapy will cease in the treatment eye and continue in the contralateral eye. The treated eye will receive via injection, a single PA5108 ocular implant. Participants will be monitored for safety and tolerability of the ocular implant until it completely biodegrades.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Grade 3 or 4 open angle glaucoma (Shaffer-Etienne scale)
- •Visual acuity in non-study eye same or better than study eye
- •Currently taking topical ocular hypotensive medication including a prostaglandin analogue
排除标准
- •Aphakic eyes
- •Only one eye
- •History of, or current uveitis, Cystoid Macular Edema (CME) or cornea edema
- •Intraocular surgery or cornea/refractive surgery in study eye in past 6 months or anticipate need for eye surgery (including laser) in study eye during study period
- •Current retinal detachment
- •Uncontrolled infection in the eye
研究组 & 干预措施
PA5108
PA5108 ocular implant (study eye) and topical prostaglandin analogue therapy (non-study eye)
干预措施: PA5108 (Drug)
结局指标
主要结局
Safety and tolerability as measured by the occurrence of adverse events
时间窗: 4 weeks
次要结局
- Timeframe to complete implant biodegradation based on implant size and location(6 months)