NCT01535495已完成1 期
Propranolol for Diabetic Retinopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Area of retinal neovascularization on fundus photography
研究概览
简要总结
This study is investigating if the oral beta antagonist propranolol can induce regression of retinal neovascularization associated with proliferative diabetic retinopathy.
详细描述
Oral propranolol 120mg daily will be given to 10 patients with proliferative diabetic retinopathy over a 12 week period to evaluate the effect on retinal neovascularization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Age >=18 years
- •Eyes with proliferative diabetic retinopathy and neovascularization
- •Eyes with a history of panretinal photocoagulation treatment and persistent neovascularization deemed by the investigator to be a potential threat to visual acuity either by causing a vitreous hemorrhage or tractional retinal detachment. (Group 1 - maximum 5 eyes enrolled with these characteristics)
- •Eyes without a history of panretinal photocoagulation treatment, but that do not have high-risk proliferative diabetic retinopathy characteristics (i.e. these are eyes that have early proliferative diabetic retinopathy that are not yet at a high-risk for vitreous hemorrhage and tractional retinal detachment such that panretinal photocoagulation laser may be deferred). (Group 2 - maximum 5 eyes enrolled with these characteristics)
排除标准
- •Either panretinal photocoagulation laser or focal/grid laser into study eye within 3 months of study enrollment
- •Anti-Vascular endothelial growth factor injection into study eye within 3 months of study enrollment
- •Contraindications to beta-blockers such as: allergy, previous intolerance, abnormally slow heart rates, asthma or chronic obstructive pulmonary disease, use of medications that have an effect on certain drug metabolic pathways that may cause interactions.
- •Known coronary arterial disease or left ventricular dysfunction, or known peripheral vascular disease
- •Resting heart rate <60 or systolic blood pressure <90 and/or diastolic blood pressure <50
- •Pregnancy
- •All patients will either be post-menopausal, have adequate birth control and, if of childbearing age, will have a urinary pregnancy test performed
- •Allergy to fluorescein dye
- •Media opacity obscuring adequate determination of neovascularization including dense cataract or dense vitreous hemorrhage
- •Patient is already taking an oral beta-blocker
- •Vulnerable populations such as prisoners and minors will also be excluded
研究组 & 干预措施
Complete laser
Experimental
Patients who have had complete panretinal photocoagulation laser treatment and active retinal neovascularization
干预措施: Propranolol (Drug)
Laser naive
Experimental
Patients who have not had panretinal photocoagulation laser treatment and active retinal neovascularization without so called "high-risk" characteristics
干预措施: Propranolol (Drug)
结局指标
主要结局
Area of retinal neovascularization on fundus photography
时间窗: 12 weeks
次要结局
- Retinopathy level in contralateral eye(12 weeks)
- Optical coherence tomography macular thickness of treated and fellow eye(12 weeks)
- Amount of fluorescein leakage on angiography(12 weeks)
- Early Treatment Diabetic Retinopathy Study visual acuity in study and fellow eye(12 weeks)
研究者
研究点 (1)
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