NCT02060604已完成4 期
A Randomised Controlled Trial of Ranibizumab With and Without Ketorolac Eyedrops for Exudative Age-related Macular Degeneration
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- mean change in study eye visual acuity as measured by the best-corrected ETDRS letter score
研究概览
简要总结
The addition of an anti-inflammatory agent could be a valid option for controlling choroidal neovascularization, as simply inhibiting VEGF addresses neither the multifactorial pathogenesis of choroidal neovascularization nor the underlying cause of VEGF production.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ability to provide written informed consent and comply with study assessments for the full duration of the study;
- •age >40 years;
- •presence of treatment-naïve neovascular AMD with a visual acuity between 20/25 and 20/200 on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Inclusion criteria for AMD were neovascularisation, fluid, or haemorrhage under the fovea.
排除标准
- •any previous intravitreal treatment;
- •previous laser treatment in the study eye;
- •myopia >7 dioptres in the study eye;
- •concurrent eye disease in the study eye that could compromise visual acuity (eg, diabetic retinopathy, advanced glaucoma);
- •concurrent corneal epithelial disruption or any condition that would affect the ability of the cornea to heal;
- •known sensitivity to any component of the formulations under investigation.
研究组 & 干预措施
Ketorolac + Ranibizumab
Experimental
3 monthly ranibizumab, then as needed plus ketorolac eyedrops TID
干预措施: Ketorolac + Ranibizumab (Drug)
Ranibizumab Alone
Active Comparator
3 monthly ranibizumab, then as needed
干预措施: Ranibizumab (Drug)
结局指标
主要结局
mean change in study eye visual acuity as measured by the best-corrected ETDRS letter score
时间窗: 12 months
次要结局
- mean change in central macular thickness(12 months)
- mean number of intravitreal injections over the 12-month period(12 months)
- adverse ocular events at 12 months(12 months)
研究者
Andrea Russo
MD
Università degli Studi di Brescia
研究点 (1)
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