EUCTR2008-007175-24-HU进行中（未招募）不适用
A randomized, controlled, two-center phase II. study assessing the efficacy and safety of intravitreal Lucentis injections in patients with clinically significant macular edema secondary to central retinal vein occlusion.Randomizált, kontrollált, két központban végzett, II. fázisú klinikai vizsgálat a vena centralis retinae elzáródása következtében kialakult, klinikailag jelentos makula ödéma kezelésére használt intravitrealis Lucentis injekció hatékonyságának és biztonságosságának értékelésére - BRAVO
niversity of Pécs, Medical School, Department of Ophthalmology0 个研究点开始时间: 2009年1月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Macular edema persisting for more than 3 months period despite conventional medication listed above.
- •Central retinal vein occlusion is confirmed by slit-lamp biomicroscopy and fluorescein angiography (FLAG).
- •Patients randomized into ranibizumab-treated group do not receive macular laser treatment.
- •Macular edema is defined by OCT: the thickness of central foveal area calculated by macular map analysis is above 280 µm and/or retinal thickness is above 330 µm at any region of the macula calculated by retinal thickness analysis.
- •Baseline visual acuity is less than 78 ETDRS letters (or 20/32 Snellen equivalent).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Diabetes mellitus
- •Additional vitreoretinal diseases
- •History of pars plana vitrectomy
- •Previous macular grid laser treatment
- •Intravitreal triamcinolone acetonid treatment
- •Complicated cataract surgery
- •Advanced glaucomatous damage of optic nerve head
- •Cataract (except mild, defined as grade 1 nuclear sclerosis and/or grade 1 posterior subcapsular cataract)
- •Age-related macular degeneration
- •Pregnancy and lactation
- •Women in childbearing potential who are not using double safe contraception
研究者
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