Effect of Topical Prophylaxis With Brinzolamide-brimonidine Fixed Combination on Intraocular Pressure Elevation After Intravitreal Injections of Anti-vascular Endothelial Growth Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- IOP at 1 minute post-injection
研究概览
简要总结
This study aims to evaluate the effect of topical prophylaxis with brinzolamide-brimonidine fixed combination on short-term intraocular pressure (IOP) elevation after intravitreal injections of anti-vascular endothelial growth factors (anti-VEGF).
Patients scheduled for treatment with intravitreal injections of anti-VEGF will be randomly divided into two groups. In control group no prophylactic medication will be used, whereas in case group one drop of brinzolamide-brimonidine fixed combination will be instilled two hours before the injection. IOP will be measured before the injection, 1 minute after the injection, 10 minutes and 30 minutes post-injection in all eyes. In case group, the pre-injection IOP will be measured prior to the administration of the fixed combination of brinzolamide-brimonidine. The iCare (IC200) tonometer will be used for IOP measurements at all time points.
详细描述
The intravitreal anti-VEGF (ranibizumab, bevacizumab, pegaptanib and aflibercept) are commonly used in the treatment of diabetic macular edema, neovascular age-related macular degeneration and other pathologies characterized by retinal or choroidal neovascularization. Intravitreal injections οf anti-VEGF agents result in an immediate and transient increase in IOP, which returns to normal within a short period of time, typically within thirty minutes. Repeated intravitreal injections and prolonged treatments seem to be associated with sustained elevation of IOP, leading to the initiation of ocular hypotensive medication and glaucoma filtration surgery. A fixed-dose combination of brinzolamide 1%, a carbonic anhydrase inhibitor, and brimonidine 0,2%, an alpha 2 adrenergic receptor agonist, represents a safe and effective drug in glaucoma treatment and its ocular hypotensive effect has been demonstrated similar to or better than the unfixed combinations of its component drugs.
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
- Single (Investigator)
盲法说明
The investigator who will measure the IOP will be masked to group assignment.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for treatment with intravitreal injections of anti-vascular endothelial growth factors
排除标准
- •history of glaucoma or ocular hypertension
- •use of topical medications (e.g. IOP-lowering medication, corticosteroids)
- •pseudoexfoliation
- •pigment dispersion syndrome
- •corneal diseases
- •active intraocular inflammation
- •any intraocular surgery in the last 6 months
研究组 & 干预措施
Brinzolamide-brimonidine fixed combination
One drop of the brinzolamide-brimonidine fixed combination is instilled in the eyes of patients two hours before the intravitreal injection
干预措施: Brinzolamide-brimonidine Fixed Combination (Drug)
结局指标
主要结局
IOP at 1 minute post-injection
时间窗: 1 minute post-injection
IOP will be measured by the same portable tonometer used before the injection (iCare-IC200 tonometer)
次要结局
- IOP at 10 minutes post-injection(10 minutes post-injection)
- IOP at 30 minutes post-injection(30 minutes post-injection)
研究者
Maria Dettoraki
Locum Specialist, Department of Ophthalmology
General Hospital of Athens Elpis