EUCTR2013-003333-15-IT进行中（未招募）1 期
A 12 months, prospective, multicenter, open-label, single arm interventional study assessing the safety and tolerability of 0.5 mg ranibizumab in mono/bilateral wet AMD patients in eyes with BCVA below 2/10 and/or second affected eye.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •- Male or female patients aged 50 years or above
- •- Willing and capable to provide informed written consent
- •- Eye(s) eligible for ranibizumab treatment, with a BCVA below 2/10 due to wet AMD
- •- Second eye eligible for ranibizumab treatment, with first eye treated (currently or previously) with ranibizumab, whichever BCVA. In bilateral wAMD patients, the second eye can be included only if the first eye has been treated at least 14 days before with ranibizumab
- •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 1000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2500
排除标准
- •- Active intraocular inflammation (grade trace or above) in either eye
- •- Any ocular or periocular active infection (current or suspected), e.g. conjunctivitis, keratitis, scleritis, uveitis, endophtalmitis, in either eye
- •- Risk factors for retinal pigment epithelial tear (including pigment epithelial retinal detachment)
- •- Ocular disorders that may confound interpretation of results compromise visual acuity or require medical or surgical intervention during the study period including cataract, retinal vascular occlusion, retinal detachment or macular hole
- •- Uncontrolled glaucoma in either eye (IOP = 30 mmHg on medication or according to investigator’s judgment)
- •- History of vitrectomy in the study eye
- •- History of stroke or transient ischemic attack
- •- Systemic treatment with any VEGF inhibitor in the 90 days prior to study enrollment
- •- Ocular treatment of the study eye with any anti-angiogenic drugs within 1 month prior to study enrollment
- •- Any intraocular surgery in the study eye within 28 days prior to enrollment
- •- Women of childbearing potential UNLESS using effective contraception during treatment
- •- Pregnant or lactating women
- •- Simultaneous participation in a study that includes administration of any investigational drug
- •- Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation
- •- Inability to comply with study procedures.
研究者
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