EUCTR2008-007467-17-IT进行中（未招募）不适用
An open-label, multi-center, 24-month extension study to evaluate the safety of ranibizumab as symptomatic treatment for visual impairment due to diabetic macular edema in patients who have completed the RESTORE trial - ND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 320
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
- •Patients must have completed the RESTORE study assessments at month 12 Patients must give written informed consent before any study related activity is performed.
- •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
- •Use of other investigational drugs Current use or likely need of systemic medications known to be toxic to the lens, retina or optic nerve History of hypersensitivity to ranibizumab or any component of the ranibizumab formulation Uncontrolled glaucoma in either eye Evidence of vitreomacular traction in either eye at visit 14 Active proliferative diabetic retinopathy in the study eye at visit 14 Intravitreal corticosteroid treatment in a phakic study eye during the core study Intravitreal corticosteroids in post-cataract surgical study eye (aphakic or pseudophakic without damaged posterior capsule) within 3 months prior to Visit 14 Ocular conditions in the study eye that require chronic concomitant therapy with topical ocular corticosteroids at visit 14 Any type of advanced, severe or unstable disease or its treatment, that could interfere with evaluations or put the patient at special risk History of stroke or transient ischemic attack (TIA) Women of child-bearing potential, UNLESS they are using two birth control methods Pregnant or nursing (lactating) women Inability to comply with study or follow-up procedures.
研究者
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