EUCTR2013-001421-55-FR进行中（未招募）1 期
An open-label Extended Clinical Protocol of ranibizumab to evaluate Safety and Efficacy in rare VEGF driven ocular diseases. - ECLIPSE
ovartis Pharma S.A.S0 个研究点目标入组 500 人开始时间: 2015年9月22日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
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 and female patients (= 18 years old)
- •Patient with diagnosis of:
- •Active choroidal neovascularization (CNV) secondary to any causes (except wAMD, PM and PXE), involving the center of the fovea, confirmed by complete ocular examination of the study eye
- •Active macular edema (ME) confirmed by complete ocular examination of the study eye, secondary to any causes:
- •oExcluding DME and RVO.
- •oIncluding non infectious uveitis, non responder or with contraindication to dexamethasone (Ozurdex®) according to investigator’s judgment
- •Rubeosis iridis/neovascular glaucoma.
- •Proliferative diabetic retinopathy requiring vitrectomy.
- •Visual loss should only be due to the presence of any eligible type of CNV or to any eligible ME or to RI/NVG or to PDR/V based on ocular clinical, as well as FA and OCT and/or ICGA findings.
- •Diagnosis of disease activity is based on investigator judgment:
- •CNV: presence of posterior pole changes compatible with active CNV (e.g. sub- or intraretinal fluid, hemorrhage), seen by fundus ophthalmoscopy, biomicroscopy and fundus photography; presence of active leakage from CNV seen by fluorescein angiography (FA) and/or ICGA; presence of intra- or subretinal fluid/hemorrhage seen by optical coherence tomography (OCT)
- •ME: presence of posterior pole changes compatible with active ME (e.g. sub-retinal fluid), seen by fundus ophthalmoscopy, biomicroscopy and fundus photography; presence of active leakage from ME seen by fluorescein angiography (FA); presence of intra-retinal fluid/cysts seen by optical coherence tomography (OCT).
- •Rubeosis iridis, NVG: surface neovascularization extension = stade 1 of Teich and Walsh grading system” seen by slit lamp examination
- •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
- •< 18 years of age
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
- •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 ß HCG laboratory test
- •History of hypersensitivity to ranibizumab
- •Use of other investigational drugs within 30 days or 5 half-lives from Baseline, whichever is longer.
- •Use of any systemic anti-angiogenic drugs 3 months before inclusion
- •CNV secondary to PM, wAMD or PXE
- •ME secondary to DME or RVO
- •Posterior segment inflammation secondary to non infectious uveitis that might benefit from dexamethasone (Ozurdex®) according to investigator judgment
- •History of intraocular treatment with any anti-angiogenic drugs (including any anti-VEGF agents) or corticosteroids within 2 months before inclusion
- •Active or suspected ocular infection
研究者
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