Phase I Study of Sequestered Transscleral, Controlled-Release Celecoxib Delivered Via Episcleral Reservoir for Treatment of Macular Edema & Inflammatory Disorders of the Eye Posterior Pole Including Sclera, Choroid, Retina or Vitreous
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- The primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam.
研究概览
简要总结
This phase I trial will assess primarily the safety and secondarily the anti-inflammatory and anti-neovascular effect of Episcleral Celecoxib in patients suffering from macular edema and other inflammatory disorders of the retina, choroid and vitreous.
详细描述
This phase I trial will assess primarily the safety and secondarily anti-inflammatory/neovascular effect of Episcleral Celecoxib in patients suffering from macular edema & inflammatory disorders of the eye posterior pole Including sclera, choroid, retina, or vitreous. Celecoxib is a specific cyclooxygenase-2 inhibitor that possesses anti-angiogenic, anti-inflammatory, and anti-fibrotic properties. Non-clinical studies have documented the activity of Celecoxib in reducing leakage of the blood-retina barrier as well as inhibiting vascular endothelial growth factor (VEGF) and prostaglandin E2 (PGE2) expression in the retina of diabetic rats. The underlying mechanisms for its anti-inflammatory and anti-angiogenic properties have been extensively characterized. The investigators hypothesize that Episcleral Celecoxib is safe, tolerable and that its anti-inflammatory/anti-neovascular activity will reduce macular edema and improve vision in patients with macular edema. Objective: to primarily assess the safety, tolerability and pharmacokinetics of Episcleral Celecoxib in patients with macular edema and other inflammatory disorders of the posterior pole including retina, choroid and vitreous to secondarily assess efficacy in reducing macular edema and improving visual function. Methods: The main outcome of the study is safety assessment. Secondary outcomes are assessment of visual acuity and anatomical changes in the macula as measured via optical coherence tomography (OCT).
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
- •Age >= 18 years;
- •Visual acuity letter score in study eye < 70 and ≥ 25 letters (approximate Snellen equivalent 20/32 to 20/320);
- •Ophthalmoscopic evidence of center-involved macular edema, within the central subfield (CSF); • Inflammatory disorders of the sclera, choroid, retina or vitreous
排除标准
- •Inability to understand informed consent, cooperate with testing or return to follow up visits;
- •Pregnant or lactating women;
- •Co-existent ocular disorder of the cornea, lens or media that will interfere with assessment of safety or efficacy.
研究组 & 干预措施
Phase I open label study
Drug: Episcleral Celecoxib
Other Names:
- Sequestered, Transscleral, Controlled-Release Celecoxib
- Sustained Release Transscleral Celecoxib
干预措施: Episcleral Celecoxib (Drug)
结局指标
主要结局
The primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam.
时间窗: 12 Months
The primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam.
次要结局
- A secondary outcome is assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).(12 Months)
- A secondary outcome is assessment of visual acuity.(12 Months)