EUCTR2008-007467-17-BE进行中（未招募）1 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 - RESTORE EXTENSIO
相关药物
试验速览
- 阶段
- 1 期
- 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
- •1. Patients must have completed the RESTORE study assessments at Month 12
- •2. Patients must give written informed consent before any study related activity of
- •this extension protocol 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
- •a. Use of investigational drugs, other than those provided in RESTORE
- •(RFB002D2301) study at the time of enrollment, or within 30 days or 5 half-lives of
- •enrollment, whichever is longer
- •b. 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
- •c. History of hypersensitivity to ranibizumab or any component of the ranibizumab
- •formulation
- •d. Uncontrolled glaucoma in either eye ( IOP > 24 mmHg on medication or according
- •to investigator’s judgment)
- •e. Evidence of vitreomacular traction in either eye at visit 14
- •f. Active proliferative diabetic retinopathy in the study eye at visit 14
- •g. Intravitreal corticosteroid treatment in a phakic study eye during the core study
- •h. Intravitreal corticosteroids in post-cataract surgical study eye (aphakic or
- •pseudophakic without damaged posterior capsule) within 3 months prior to Visit
- •i. Ocular conditions in the study eye that require chronic concomitant therapy with
- •topical ocular corticosteroids at visit 14
- •j. 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
- •k. History of stroke or transient ischemic attack (TIA)
- •l. Women of child-bearing potential, defined as all women physiologically capable of
- •becoming pregnant, UNLESS they are using two birth control methods. The two
- •methods can be a double barrier method or a barrier method plus a hormonal
- •method. Adequate barrier methods of contraception include: diaphragm, condom
- •(by the partner), intrauterine device (copper or hormonal), sponge or spermicide.
- •Hormonal contraceptives include any marketed contraceptive agent that includes
- •an estrogen and/or a progestational agent.
- •m. 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 (> 5 mIU/mL)
- •n. Inability to comply with study or follow-up procedures.
- •No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.
研究者
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