Prospective Randomized Controlled Trial of Combination Ranibizumab and Indomethacin for Exudative Age-Related Macular Degeneration
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 58
- 主要终点
- Central Retinal Thickness (microns)
研究概览
简要总结
To evaluate whether indomethacin eyedrops plus intravitreal ranibizumab (IVR) provides additional benefit over IVR monotherapy for treatment of choroidal neovascularization (CNV) in age-related macular degeneration.
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
- •provision of written informed consent and compliance with study assessments for the full duration of the study
- •age > 40 years
- •presence of treatment-naïve neovascular AMD.
排除标准
- •any previous intravitreal treatment
- •previous laser treatment in the study eye
- •myopia > 7 diopters in the study eye
- •concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy and 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 being investigated.
研究组 & 干预措施
Ranibizumab Monotherapy
All patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata
干预措施: Ranibizumab Injection (Drug)
Ranibizumab + Indomethacin
All patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata. Moreover, patients also self- administered one drop of indomethacin three times a day for 12 months. All patients were followed up for 12 months.
干预措施: Ranibizumab Injection (Drug)
Ranibizumab + Indomethacin
All patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata. Moreover, patients also self- administered one drop of indomethacin three times a day for 12 months. All patients were followed up for 12 months.
干预措施: Indomethacin (Drug)
结局指标
主要结局
Central Retinal Thickness (microns)
时间窗: 12-month
Optical Coherence Tomography will be used to assess central retinal thickness.
Visual Acuity (LogMAR)
时间窗: 12-month
ETDRS charts will be used to assess best corrected visual acuity
次要结局
未报告次要终点
研究者
Andrea Russo
Principal Investigator
Università degli Studi di Brescia