Phase I Study of Sequestered Transscleral, Controlled-Release Dexamethasone 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
- 2
- 试验地点
- 1
- 主要终点
- A 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 anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from macular edema and other disorders of the retina, choroid and vitreous.
详细描述
This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from macular edema and other disorders of the retina, choroid and vitreous. Numerous studies have documented the anti-inflammatory activity of Dexamethasone in macular edema associated with diabetes, branch retinal vein occlusion, and non-infectious posterior uveitis. The investigators hypothesize that Episcleral Dexamethasone is safe, tolerable and that its anti-inflammatory activity will interface with the pro-inflammatory cascade associated with macular edema due to diabetes, surgery, trauma, vein occlusions, uveitis and retinal degeneration to improve visual structure and function. The investigators hypothesize that Episcleral Dexamethasone is safe, tolerable and that its anti-inflammatory activity will reduce macular edema and improve vision. The investigator's objective is to primarily assess the safety, tolerability and pharmacokinetics of Episcleral Dexamethasone in patients with macular edema; to secondarily assess efficacy in reducing macular edema and improving visual structure and function. 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) and fluorescein angiogram.
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 Dexamethasone Sequestered Transscleral, Controlled-Release Dexamethasone
Other Names:
• Sustained Release Transscleral Dexamethasone
干预措施: Episcleral Dexamethasone (Drug)
结局指标
主要结局
A primary outcome measure of the study is ocular safety assessment as measured by comprehensive ophthalmic exam.
时间窗: 12 Months
Assessment of ocular safety as measured by comprehensive ophthalmic exam.
次要结局
- A secondary outcome is assessment of visual acuity.(12 Months)
- A secondary outcome is assessment of anatomical changes in the macula as measured via optical coherence tomography (OCT).(12 Months)
