ISRCTN12980412已完成不适用
A prospective randomised controlled trial assessing the efficacy of intravitreal bevacizumab in patients with minimally classic and occult choroidal neovascularisation secondary to age-related macular degeneration
Frimley Park Hospital NHS Trust (UK)0 个研究点目标入组 100 人开始时间: 2007年12月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age >50 years
- •2. Fluorescein angiographic evidence of minimally classic or occult choroidal neovascular membrane
- •3. Best Corrected Visual Acuity (BCVA) 20/40 - 20/320
- •4. BCVA in no study eye better than 20/320
- •5. If both eyes are eligible then only the worst eye will be enrolled
- •6. Willing to attend scheduled visits
排除标准
- •1. Medical conditions:
- •1.1. Uncontrolled hypertension
- •1.2. Patients on more than 3 antihypertensive medications
- •1.3. Patients in whom a change in anti-hypertensive drug was initiated within 3 months preceding baseline visit.
- •1.4. Previous thrombembolic phenomenon
- •1.5. On Warfarin or anticoagulants
- •1.6. Recent Myocardial Infarction (MI)
- •1.7. Recent major surgery (within 28 days)
- •2. Ocular conditions:
- •3. Glaucoma (IntraOcular Pressure [IOP] >25, on anti-glaucoma treatment, glaucoma surgery)
- •4. Active intraocular or extraocular inflammation
- •5. Retinal vascular disease
- •6. Other sources of chorodal neovascular membrane
- •7. Previous PhotoDynamic Therapy (PDT)
- •8. Predominantly classic membranes
- •9. Previous cataract surgery (within 6 months)
- •10. Aphakia
- •11. Other retinal conditions that may effect visual outcome
- •3.1. Allergy to Fluorescein
- •3.2. Inability to obtain colour photographs, fluorescein angiogram, Optical Coherence Tomography (OCT) images
- •3.3. Allergy to anti Vascular Endothelial Growth Factor (VEGF) medications
- •3.4. Allergy to humanised monoclonal antibody
- •3.5. Inability to comply with follow-up procedures
研究者
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