EUCTR2008-001469-28-AT进行中（未招募）不适用
A randomized, double-masked study with intraocular Bevacizumab (Avastin®) compared with intravitreal Ranibizumab (Lucentis®) in patients with persistent diabetic macular edema or persistent active neovascularisation following lasercoagulation
Dep. of Ophthalmology, Medical University of Vienna0 个研究点目标入组 60 人开始时间: 2009年1月9日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •Signed informed consent • Age =18 years • Patients with type 1 or type 2 diabetes mellitus • HbA1C between 6% and 9 %. • Patients with persistent diabetic macular edema with center involvement following completed grid lasercoagulation in the study eye • Last perifoveolar laser treatment 3 months before study entry • Central macular thickness (macular edema) of at least 300 - 550 microns in the central subfield as measured by OCT • Not eligible for any currently approved treatments or experimental protocols • Best corrected visual acuity, using ETDRS charts, of 20/25 to 20/200 (Snellen equivalent) in the study eye • Patients with decrease in vision in the study eye due to foveal thickening from diabetic macular edema and not to other causes, in the opinion of the investigator • Patients without a necessity for panretinal laser photocoagulation for at least 3 months after study inclusion • If both eyes are eligible, the one with the worse visual acuity will be selected for study treatment unless, based on medical reason, the investigator deems the other eye have got more benefit from study treatment.
- •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 condition that would preclude a patient for participation in the study in opinion of investigator, e.g., unstable medical status including glycemic control and blood pressure • History of systemic corticosteroids within 3 months prior to randomization or topical, rectal or inhaled corticosteroids in current use more than 3 times per week Prior/Concomitant Treatment • Panretinal laser photocoagulation within the past 3 months or macular laser photocoagulation within the past 3 months in the study eye • Previous treatment with intravitreal or sub-Tenon triamcinolone within the past 3 months in the study eye • Previous participation in clinical trial involving anti-angiogenic drugs (pegabtanib sodium, ranibizumab, anecortave acetate, protein kinase C inhibitor, etc.) • History of submacular surgery or other surgical intervention for diabetic macular edema except grid lasercoagulation in the study eye • Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals) Diabetic Retinopathy Characteristics • High risk proliferative diabetic retinopathy in the study eye without complete panretinal lasercoagulation and having a risk for intravitreal bleeding Concurrent Ocular Conditions • Active intraocular inflammation (grade trace or above) in either eye • Vitreomacular traction in the study eye evident by OCT • Current vitreous hemorrhage in the study eye (Group A) • Infectious conjunctivitis, keratitis, scleritis, endophthalmitis as well as idiopathic or autoimmuneassociated uveitis in either eye • Structural damage to the center of macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of retinal pigment epithelium, subretinal fibrosis, laser scar within foveal avascular zone (FAZ) or organized hard exudate plaques (Group A) • Ocular disorders in the study eye including retinal vascular occlusion, retinal detachment, macular hole, choroidal neovascularisation • Intraocular surgery (including cataract surgery, YAG laser capsulotomy) in the study eye within 3 months preceding Day 0 • Uncontrolled glaucoma in the study eye (defined as intraocular pressure =25 mmHg despite treatment with anti-glaucoma medication) • History of glaucoma filtration surgery, corneal transplantation in the study eye Concurrent Systemic Conditions • Systemic hypertension (> 150/100 mmHg) • History of myocardial infarction (in anamnesis or signs in ECG) • History of congestive heart failure • History of stroke or transient ischemic attacks • Significant abnormalities on laboratory testing (signs on failure of kidney, liver disease) • Premenopausal women not using adequate contraception and pregnant or nursing women The following are considered effective means of contraception: surgical sterilization; use of oral contraceptives; barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel; an IUD; or contraceptive hormone implant or patch. • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications • Current treatment for active systemic infection Other • History of allergy to f
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