EUCTR2012-005417-38-LT进行中（未招募）不适用
A 12-month, randomized, double-masked, sham-controlled, multicenter study to evaluate the efficacy and safety of 0.5mg ranibizumab intravitreal injections in patients with visual impairment due to vascular endothelial growth factor (VEGF)-driven choroidal neovascularization (CNV)
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
- 187
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
- •Diagnosis of active CNV secondary to any causes (for adult patients: except wAMD, PCV or PM), with the CNV or its sequelae affecting the fovea, confirmed by at least one of the three following criteria:
- •a) Presence of posterior pole changes compatible with active CNV seen by fundus ophthalmoscopy and/or biomicroscopy
- •b) Presence of leakage from CNV seen by fluorescein angiography (FA)
- •c) Presence of intra- or subretinal fluid seen by optical coherence tomography (OCT)
- •At least one of the following CNV lesion types present in the study eye:
- •a) Subfoveal (presence of abnormal neovasculature in the avascular central fovea)
- •b) Juxtafoveal (presence of abnormal neovasculature not under the center of the fovea but within 200 µm from the center) with involvement of the central macular area
- •c) Extrafoveal (presence of abnormal neovasculature more than 200 µm from the center of the fovea) with involvement of the central macular area
- •d) Margin of the optic disc (presence of abnormal neovasculature at peripapillary area) with involvement of the central macular area
- •BCVA must be between = 24 and = 83 letters tested at 4 meters starting distance using ETDRS-like visual acuity charts (approximate Snellen chart equivalents of 20/25 and 20/320) in the study eye
- •Visual loss in the study eye should mainly be due to the presence of any eligible types of CNV (for adult patients: non-wAMD and non-PM) based on ocular clinical, as well as FA and/or OCT findings
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 157
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •For both eyes
- •Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation (e.g., anterior chamber cells (ACC) >2+ and/or vitreous haze (VH) >2+). Rescreening is permitted after intra-ocular inflammation is successfully treated with antiinflammatory therapy that does not compromise eligibility
- •Confirmed intraocular pressure (IOP) = 25 mmHg for any reason
- •Neovascularization of the iris or neovascular glaucoma
- •Inability to obtain fundus photographs, fluorescein angiograms or OCT images of sufficient quality to be analyzed
- •For study eye
- •CNV secondary to wAMD, PCV or PM (for adult patients only). RAP lesions are exclusionary in patients 50 years of age or older
- •Ocular disorders that could confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the 12-month study period (including retinal detachment, cataract (if causing significant visual impairment), macular hole and preretinal membrane of the macula)
- •Any type of ocular advanced, severe or unstable disease or its treatment that could interfere with the primary and/or secondary outcome evaluations.
- •CNV- conditions with a high likelihood of spontaneous resolution (e.g., CNV due to choroidal rupture), unless deemed chronic by the Investigator (e.g., lasting for > 2 months or being recurrent). History of laser photocoagulation with involvement of the macular area at any time
- •Verteporfin photodynamic therapy (vPDT) at any time
- •History of intraocular treatment with any anti-angiogenic drugs within 6 months of the Baseline visit (e.g., bevacizumab [Avastin®], aflibercept [Eylea®], pegaptanib [Macugen®], ranibizumab [Lucentis®])
- •History of intravitreal treatment with steroids, e.g., triamcinolone within 6 months of the Baseline visit
- •History of treatment with intravitreal implants (e.g., Illuvien®, Ozurdex®, Retisert®) at any time
- •History of vitreoretinal surgery at any time (cataract surgery is not an exclusion criterion unless a large removal of vitreous or removal of posterior vitreous has occurred)
研究者
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