Trientine Hydrochloride for the Prevention of Macular Edema After Cataract Surgery in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in retinal thickness measurements by Optical Coherence Tomography (OCT) from screening to Day 28 between subjects undergoing surgery with and without Trientine use.
研究概览
简要总结
The primary purpose of the protocol is to evaluate whether Trientine Hydrochloride, a copper chelator which is an agent that binds with and removes copper, will be effective in minimizing macular edema after cataract surgery in individuals with type 2 diabetes. It is our hypothesis that there will be a reduction in copper-attributed inflammation after surgery resulting a decrease in edema.
详细描述
Individuals with type II Diabetes Mellitus who present to the UBC/VGH Eye Care Centre for cataract surgery will be offered participation in this study. Cataract surgery will be performed according to the surgeons' normal protocols and the present standards of care; however, subjects will be randomized to either a 10-day course of oral Trientine at 1500mg/day administered for 7 days prior to and 3 days after the surgery, or to placebo. Urinary copper levels will be evaluated before and after Trientine administration to determine the efficacy of copper chelation at the time of surgery.
Baseline ocular exams, bloodwork and urine collection will be organized or performed at the two screening visits up to two months before the date of cataract surgery according to the research protocol (flowsheet included at the end). Subjects will also be evaluated at Day1 post-operative, Day 7 (Week #1) post operative, and Day 28-30 (Month 1)post operative with Ocular Coherence Tomography (retinal thickness measurements). Fundus photography and visual acuity testing will be done at Screening and month 1. A final phlebotomy to rule out copper deficiency anemia will be required at month 1 as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
B
Oral Placebo x 1 week before cataract surgery and 3 days post surgery
干预措施: For Arm B there is no therapeutic intervention other than standard of care, which is cataract surgery. (Other)
A
Oral Trientine 1500mg x 1 week before cataract surgery and 3 days post surgery
干预措施: Trientine Hydrochloride (Drug)
结局指标
主要结局
Change in retinal thickness measurements by Optical Coherence Tomography (OCT) from screening to Day 28 between subjects undergoing surgery with and without Trientine use.
时间窗: Screening, Day 28
次要结局
- Secondary analyses will involve evaluations of the change in visual acuity and fundus photography results from screening to Day 28.(Screening, Day 28)
研究者
David Maberley
Principal Investigator
University of British Columbia