Niacin (as a Vasodilator), and a Topical Steroid (for Macular Edema), Non-Ischemic CRVO,HRVO,BRVO
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Number of Participants With An Improvement in Vision, as Measured by an Increase of 15 Letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) Vision Chart.
研究概览
简要总结
The purpose of this study is to determine whether Niacin, a B vitamin, may act as a vasodilator to encourage earlier formation of collateral blood vessels that may serve to bypass the obstructed vein in the eye. The topical steroid eye drops are aimed at reducing swelling in the retina, until the collateral vessels have a chance to develop.
详细描述
The aim of this study is to develop a less risky, yet effective and more sustainable treatment for retinal vein occlusions than the current commonly used approach of repeated intravitreal triamcinolone acetonide (Kenalog) injections. The types of retinal vein occlusion that are being studied include central (CRVO), hemi-retinal (HRVO), and branch (BRVO) retinal vein occlusion. Niacin, (Nicotinic Acid, not Nicotinamide)a B-vitamin, has lipid lowering and vasodilating properties. The combination of Niacin and Prednisolone Acetate steroid eye drops as a non-invasive treatment approach was developed by the Principal Investigator. The Niacin dilates the retinal vessels, hopefully encouraging earlier collateral vessel formation aimed at bypassing the venous obstruction, thus restoring venous outflow. The Prednisolone Acetate steroid eye drops are aimed at reducing vascular leakage and therefore the macular edema in the eye while the Niacin is taking effect.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be able to understand the study procedures, agree to participate, and give written consent.
- •Patient must have central retinal vein occlusion, hemi-retinal vein occlusion or branch retinal vein occlusion.
- •Patients must be able to follow the study medication regimen.
- •Patients must agree to return for the once monthly eye exams.
- •Patients must agree to have liver function tests performed on a regular basis.
- •Patients must agree to have regular appointments with their Internist on an established basis.
排除标准
- •Patients with active Gout, or high levels of Uric
- •Patients may not be pregnant or lactating.
- •The Principal Investigator reserves the right to exclude any patient who he feels will not make a good candidate.
研究组 & 干预措施
Prospective active treatment
Niacin 500mg TID PO for treatment of retinal vein occlusions.
干预措施: Nicotinic acid (Drug)
Prospective active treatment
Niacin 500mg TID PO for treatment of retinal vein occlusions.
干预措施: Prednisolone acetate (Drug)
结局指标
主要结局
Number of Participants With An Improvement in Vision, as Measured by an Increase of 15 Letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) Vision Chart.
时间窗: one year
improvement with combination of niacin and topical prednisolone acetate
次要结局
- A Decrease in the Thickness of the Retina(one year)