EUCTR2008-007232-18-HU进行中（未招募）不适用
Comparison of the effect of intravitreal ranibizumab injections compared to macular grid-pattern laser therapy for the symptomatic treatment of diabetic macular edema (a randomized, controlled, phase III trial)Randomizált, kontrollált, III. fázisú klinikai vizsgálat az intravitreális ranibizumab injekció és a makula „grid pattern” (rács mintázatú) lézerkezelés hatásának összehasonlítására a diabéteszes makula ödéma tüneti kezelésében.
niversity of Szeged, Medical and Pharmaceutical Center, Department of Ophthalmology0 个研究点目标入组 50 人开始时间: 2009年2月16日最近更新:
适应症
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
- 50
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. Male of female type I. or II. diabetic patients over 18 years of age.
- •2. Diagnosis of DME secondary to diabetic retinopathy, and decrease in vision is due to DME and not due to other causes, in the opinion of the investigator.
- •3. Patients who have a BCVA score between 78 and 39 letters in the study eye using ETDRS-like visual acuity charts at a testing distance of 4 meters.
- •4. Expectation by the investigator that patient will potentially benefit from laser treatment or ranibizumab treatment.
- •5. Willing and able to comply with all study procedures.
- •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
- •1. Active intraocular inflammation, any active infection or history of uveitis
- •2. Uncontrolled glaucoma or neovascularization of the iris in study eye
- •3. Structural damage within 0.5 disc diameter of the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques
- •4. Concurrent disease in the study eye that could compromise visual acuity or prevent the improvement of visual acuity (including diabetic proliferative retinopathy) or require medical or surgical intervention during the study period, including cataract, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause.
- •5. Panretinal laser photocoagulation in the study eye within 6 months prior to or during the study or focal/grid laser photocoagulation in the study eye within 3 months prior to study entry
- •6. Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) or intravitreal corticosteroids in study eye within 3 months prior to randomization
- •7. Any intraocular surgery in the study eye within 3 months prior to randomization
- •8. History of vitrectomy in study eye
- •9. Ocular conditions in the study eye that require chronic concomitant therapy with topical ocular or systemically administered corticosteroids
- •10. Pregnancy and lactation
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