Treatment of Exudative Age-Related Macular Degeneration With Aflibercept Combined With Pranoprofen Eye Drops or Nutraceutical Support With Omega-3: A Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Central Retinal Thickness (microns)
研究概览
简要总结
To determine whether a combination of intravitreal aflibercept and pranoprofen eyedrops or nutraceutical support provides additional benefit over IVA monotherapy for the treatment of choroidal neovascularization 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
aflibercept monotherapy
All patients received monthly 0.5 mg aflibercept intravitreal injections for 3 months, after which monthly injections were administered pro re nata
干预措施: Aflibercept Injection [Eylea] (Drug)
aflibercept plus pranoprofen
All patients received monthly 0.5 mg aflibercept intravitreal injections for 3 months, after which monthly injections were administered pro re nata. Moreover, patients also self- administered one drop of pranoprofen (Pranoflog; Sifi SpA, Aci Sant'Antonio, CT, Italy) three times a day for 12 months. All patients were followed up for 12 months.
干预措施: Aflibercept Injection [Eylea] (Drug)
aflibercept plus pranoprofen
All patients received monthly 0.5 mg aflibercept intravitreal injections for 3 months, after which monthly injections were administered pro re nata. Moreover, patients also self- administered one drop of pranoprofen (Pranoflog; Sifi SpA, Aci Sant'Antonio, CT, Italy) three times a day for 12 months. All patients were followed up for 12 months.
干预措施: Pranoprofen Eyedrops (Drug)
aflibercept plus nutraceutical
All patients received monthly 0.5 mg aflibercept intravitreal injections for 3 months, after which monthly injections were administered pro re nata. Moreover, patients were given daily tablets of Omega-3 supplementation (Azyr Mega; Sifi SpA, Aci Sant'Antonio, CT, Italy).
干预措施: Aflibercept Injection [Eylea] (Drug)
aflibercept plus nutraceutical
All patients received monthly 0.5 mg aflibercept intravitreal injections for 3 months, after which monthly injections were administered pro re nata. Moreover, patients were given daily tablets of Omega-3 supplementation (Azyr Mega; Sifi SpA, Aci Sant'Antonio, CT, Italy).
干预措施: Omega-3 Supplementation (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
Andrea Russo; MD, PhD
Università degli Studi di Brescia