NCT01769183已完成2 期
Topical Squalamine in the Treatment of Retinal Neovascularization From Proliferative Diabetic Retinopathy
Elman Retina Group1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Proportion with complete regression of neovascularization on fundus photography at one month
研究概览
简要总结
The purpose of this study is to determine the efficacy in the use of topical Squalamine Lactate Ophthalmic Solution, 0.2% in the treatment of retinal neovascularization resulting from proliferative diabetic retinopathy.
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
- 是
入选标准
- •Age >= 18 years
- •Individuals <18 years old are not being included because PDR is so rare in this age group that the diagnosis of PDR may be questionable.
- •Diagnosis of diabetes mellitus (type 1 or type 2)
- •Any one of the following will be considered to be sufficient evidence that diabetes is present:
- •Current regular use of insulin for the treatment of diabetes
- •Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
- •Documented diabetes by ADA and/or WHO criteria (see Procedures Manual for definitions)
- •At least one eye meets the study eye criteria
- •Able and willing provide informed consent
排除标准
- •Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- •A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
- •Individuals in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled.
- •Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval for the indication being studied.
- •Note: study participants cannot receive another investigational drug while participating in the study.
- •Known allergy to any component of the study drug.
- •Blood pressure > 180/110 (systolic above 180 or diastolic above 110).
- •If blood pressure is brought below 180/110 by anti-hypertensive treatment, individual can become eligible.
- •Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
- •Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization.
- •These drugs should not be used during the study.
- •For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
- •Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed.
- •Individual is expecting to move out of the area of the clinical center during the study.
- •History of allergy to Squalamine
研究组 & 干预措施
Squalamine
Experimental
Study eyes will be assigned to receive Squalamine. The dose will be one drop twice daily. If neovascularization fails to regress at week one or if neovascularization returns within the study, the dose will be increased to four times daily. In that case, a one day and one week visit will be added after increasing the dose. Patients will continue administering study drug until week 20.
干预措施: Squalamine Lactate ophthalmic solution 0.2% (Drug)
结局指标
主要结局
Proportion with complete regression of neovascularization on fundus photography at one month
时间窗: 1 Month
次要结局
- Mean Change in Visual Acuity from Baseline to 5 Months(5 months)
研究者
研究点 (1)
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