The State of the Blood-Aqeous Barrier During Anti-Angiogenic Therapy in Patients With Exudative Age-Related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- laser flare photometry values in the aqueous humor
研究概览
简要总结
To evaluate the status of the blood-aqueous barrier by objectively measuring protein concentration in the aqueous humor using laser flare photometry (LFP) in patients with exudative age-related macular degeneration (AMD) undergoing anti-angiogenic therapy.
详细描述
All patients were assigned to two groups. The first group was administered intravitreal injections of 2 mg (0.05 mL) aflibercept, while the second group received 6 mg (0.05 mL) brolucizumab. The regimen of treatment in both groups was treat-and-extend
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 47 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •only primary, untreated patients with exudative AMD who were eligible for anti-VEGF therapy were included in the study. -
排除标准
- •patients with hyperlipidemia, cardiac or renal insufficiency, ocular neoplasms, glaucoma, as well as those with corneal opacity within the optical zone or any inflammation of the studied eye that could lead to increased light-scattering intensity of protein molecules in the anterior chamber fluid, as measured by laser flare photometry, were excluded from the study.
研究组 & 干预措施
Group of aflibercept
The first group (15 patients (17 eyes)) was administered intravitreal injections of 2 mg (0.05 mL) aflibercept.
干预措施: laser flare photometry before intravitreal injection (Diagnostic Test)
Group of brolucizumab
The second group (15 patients (16 eyes)) received 6 mg (0.05 mL) brolucizumab.
干预措施: laser flare photometry before intravitreal injection (Diagnostic Test)
结局指标
主要结局
laser flare photometry values in the aqueous humor
时间窗: 6-month
Detection of protein concentration in the aqueous humor using laser flare photometry
次要结局
- best-corrected visual acuity(6-month)
- central retinal thickness(6-month)
研究者
Andrii Korol, MD, PhD
Official Title: MD, PhD, DMedSc,Prof
The Filatov Institute of Eye Diseases and Tissue Therapy