NCT00994799Unknown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)
Szeged University3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Mean change in best corrected visual acuity
研究概览
简要总结
This study investigates the hypothesis that ranibizumab injection given into the eye is an efficacious and safe treatment option applied for swelling of the macula (site of sharp vision) in diabetes.
详细描述
This is a randomized, controlled, three-center trial to assess the efficacy and safety of intravitreal ranibizumab injections in diabetic macular edema. Comparator arm consists of patients receiving macular grid-pattern laser therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female type I or II diabetic patients over 18 years of age
- •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
- •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
- •Expectation by the investigator that patient will potentially benefit from laser treatment or ranibizumab treatment
- •Willing and able to comply with all study procedures
排除标准
- •Active intraocular inflammation, any active infection or history of uveitis
- •Uncontrolled glaucoma or neovascularization of the iris in the study eye
- •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
- •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
- •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
- •Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc) or intravitreal corticosteroids in the study eye within 3 months prior to randomization
- •Any intraocular surgery in the study eye within 3 months prior to randomization
- •History of vitrectomy in the study eye
- •Ocular conditions in the study eye that require chronic concomitant therapy with topical ocular or systemically administered corticosteroids
- •Pregnancy and lactation
研究组 & 干预措施
ranibizumab group
patients receiving intravitreal ranibizumab for diabetic macular edema
干预措施: ranibizumab (Drug)
laser
patients receiving macular grid-pattern laser therapy
干预措施: macular grid-pattern laser (Radiation)
结局指标
主要结局
Mean change in best corrected visual acuity
时间窗: 12 months
次要结局
- Mean change in retinal thickness as assessed with OCT(12 months)
- Change in the extension of foveal avascular zone, foveal thickness and macular volume by FA and OCT, respectively.(12 months)
- Change in retinal function (color vision,contrast sensitivity, multifocal ERG)(12 months)
- Rate of adverse events(12 months)
研究者
研究点 (3)
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