跳至主要内容
临床试验/NCT04120311
NCT04120311进行中(未招募)1 期

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

Targeted Therapy Technologies, LLC1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2019年9月1日最近更新:
适应症
干预措施

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

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

Experimental

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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