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临床试验/NCT02051946
NCT02051946已完成1 期

Novel Drug Delivery Technique for Glaucoma Patients

Molly Walsh1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
9
试验地点
1
主要终点
Change in Intraocular pressures (IOP) lowering effect

研究概览

简要总结

The purpose of this study is to identify whether or not injection of a study drug (ethacrynic acid) using the investigational Retroject device is able to lower eye pressures in patients with advanced glaucoma. 20 patients with advanced glaucoma with visual acuity less than 20/200 and intraocular pressures (IOP) >20mmHg on maximum medical therapy will be asked to participate in the study. The first five patients will have the Retroject device placed over their eye for 30 seconds and then removed. Assuming no issues, then it will be placed on the eye for one minute. The second group of patients (3 total) will have the Retroject device placed on the eye and then an injection of ethacrynic acid into the episcleral vein. The third group of patients (12 total) will have the Retroject device placed on the eye and then will be randomized in a 2:1 ratio to receive either an ethacrynic acid injection or a balanced salt solution injection. All 20 patients will then return for intraocular pressure measurements on days 1, 2, 3, and 7 as well as 6 weeks after injection. In addition, the patients will undergo pre and post intervention corneal endothelial assessments (endothelial cell count, shape analysis, and pachymetry). Potential safety issues are unlikely and include bleeding, infection, pain, ototoxicity, or temporary or permanent loss of vision.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 55 years or older of both sexes
  • IOP >20 mmHg on maximal treatment
  • <20/200 visual acuity
  • willing to sign informed consent forms

排除标准

  • monocular patients with bleeding disorders
  • patients on anticoagulant or antiplatelet medications
  • patients who had prior laser surgeries (SLT or ALT)

研究组 & 干预措施

Retroject device only

Active Comparator

The first 5 patients enrolled will serve as controls and will have the device alone placed on the eye (without an injection of ethacrynic acid).

干预措施: Retroject Device (Device)

Retroject injection with ethacrynic acid injection

Experimental

The next 3 patients, after the first 5 controls, will have the device placed on the eye with a subsequent injection of ethacrynic acid into the episcleral vein.

干预措施: Retroject Device (Device)

Retroject injection with ethacrynic acid injection

Experimental

The next 3 patients, after the first 5 controls, will have the device placed on the eye with a subsequent injection of ethacrynic acid into the episcleral vein.

干预措施: ethacrynic acid injection (Drug)

randomization to ethacrynic acid or balanced salt solution

Experimental

The last 12 patients will all have the device placed on their eye. They will then be randomized in a 2:1 ratio to receive either an injection of ethacrynic acid or balanced salt solution.

干预措施: Retroject Device (Device)

randomization to ethacrynic acid or balanced salt solution

Experimental

The last 12 patients will all have the device placed on their eye. They will then be randomized in a 2:1 ratio to receive either an injection of ethacrynic acid or balanced salt solution.

干预措施: ethacrynic acid injection (Drug)

randomization to ethacrynic acid or balanced salt solution

Experimental

The last 12 patients will all have the device placed on their eye. They will then be randomized in a 2:1 ratio to receive either an injection of ethacrynic acid or balanced salt solution.

干预措施: balanced salt solution (Drug)

结局指标

主要结局

Change in Intraocular pressures (IOP) lowering effect

时间窗: Days 1, 2, 3, and 7, and 6 weeks after injection

The patients will then return for intraocular pressure measurements on days 1, 2, 3, and 7 as well as 6 weeks after injection. Differences in baseline IOP versus post-injection IOP will be calculated for each patient.

次要结局

未报告次要终点

研究者

发起方
Molly Walsh
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Molly Walsh

Assistant Professor

Duke University

研究点 (1)

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