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
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Visual Acuity (LogMAR)
研究概览
简要总结
Although evidence have clearly proved that intravitreal injection of vascular endothelial growth factor antagonists prevents vision loss and may even improve visual acuity in patients with neovascular AMD, a significant percentage of patients continue to lose visual acuity. Moreover, monthly intravitreal injections represent a burden for society as well as the caregiver.
Combination therapy with either topical 0.1% pranoprofen or nutraceutical support with AREDS2 formula plus omega-3 might act synergistically with intravitreal injection, offering valuable therapeutic support to aflibercept injections in patients requiring long-term treatment.
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
AM group
Intravitreal aflibercept monotherapy
干预措施: Aflibercept (Drug)
AP group
Intravitreal aflibercept along with 0.1% pranoprofen
干预措施: Aflibercept (Drug)
AP group
Intravitreal aflibercept along with 0.1% pranoprofen
干预措施: Pranoprofen (Drug)
AN group
Intravitreal aflibercept plus daily supplementation of nutraceutical tablets
干预措施: Aflibercept (Drug)
AN group
Intravitreal aflibercept plus daily supplementation of nutraceutical tablets
干预措施: Carotenoids (Dietary Supplement)
结局指标
主要结局
Visual Acuity (LogMAR)
时间窗: 12-month
ETDRS charts will be used to assess best corrected visual acuity
Central Retinal Thickness (microns)
时间窗: 12-month
Optical Coherence Tomography will be used to assess central retinal thickness.
次要结局
未报告次要终点
研究者
Francesco Semeraro
Dr. Francesco Semeraro
Università degli Studi di Brescia