NL-OMON33189尚未招募3 期
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 - CRFB002D2301-E1, RESTORE extensie
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- ovartis
- 入组人数
- 10
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
- 年龄范围
- 18 至 99（—）
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 of this extension protocol is performed.
排除标准
- •- Ocular Conditions:
- •- 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;Ocular treatments:
- •- 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;Systemic conditions or treatments
- •- Current use or likely need of systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol
- •- History of hypersensitivity to ranibizumab or any component of the ranibizumab
- •formulation
- •- Any type of advanced, severe or unstable disease or its treatment, that could interfere with primary and/or secondary outcome evaluations including any medical condition that could be expected to progress, recur, or change to such an extend that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk
- •- History of stroke or transient ischemic attack (TIA);Complience / Administrative:
- •- Use of investigational drugs, other than those priovided in RESTORE study at the time of enrollment,
- •- Women of child-bearing potential, defined as all women physiologically capable of
- •becoming pregnant, UNLESS they are using two birth control methods.
- •- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
- •- Inability to comply with study or follow-up procedures.
研究者
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