Bevacizumabe e Acetato de Triancinolona Intra-vítreo Associados à Laserterapia em Pacientes Com Edema Macular diabético (IBeTA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Central subfield macular thickness
研究概览
简要总结
Purpose: To compare the effects of macular photocoagulation with or without intravitreal bevacizumab (IVB) or triamcinolone (IVTA) for the treatment of diabetic macular edema (DME). Casuistic and Methods: 58 eyes of 44 patients with diffuse DME were randomized to receive either IVB + focal/grid laser (IVB-Laser, n=19), IVTA + focal/grid laser (IVTA-Laser, n=16) or focal/grid laser alone (Laser, n=23). Ophthalmic evaluation, including best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central macular thickness (CMT) were performed at baseline and monthly for 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •clinically significant diabetic macular edema (DME) with diffuse leakage involving the center of the fovea, with DME greater than 275 microns in OCT examination
- •BCVA between 0.3 LogMAR (logarithm of smaller angle of visual resolution) (20/40) and 1.6 LogMAR (20/800)
- •signed of inform Consent.
排除标准
- •HbA1c levels greater than 10%
- •thromboembolic event history (including myocardial infarction and stroke)
- •vitreo-macular traction on OCT
- •coagulation disorders
- •macular ischemia on fluorescein angiography examination
- •proliferative diabetic retinopathy that required treatment
- •eye surgery
- •history of ocular hypertension or glaucoma
- •any ocular pathology which in the opinion of the investigator, could macular edema or change the visual acuity during the study period (for example, retinal vascular occlusion, uveitis or other inflammatory eye disease, neovascular glaucoma)
- •systemic corticosteroid therapy
- •any conditions that could affect the documentation
- •any previous treatment for diabetic macular edema.
研究组 & 干预措施
IVTA-Laser
Intravitreal Triamcinolone combined with focal laser therapy
干预措施: Laser (Device)
IVB-Laser
Intravitreal Bevacizumab combined with focal laser therapy
干预措施: Laser (Device)
IVB-Laser
Intravitreal Bevacizumab combined with focal laser therapy
干预措施: Bevacizumab (Drug)
IVTA-Laser
Intravitreal Triamcinolone combined with focal laser therapy
干预措施: Triamcinolone Acetonide (Drug)
Laser
focal laser therapy
干预措施: Laser (Device)
结局指标
主要结局
Central subfield macular thickness
时间窗: 12 months
retinal thickness measured with optical coherence tomography
Visual acuity
时间窗: 12 months
Best corrected visual acuity
次要结局
未报告次要终点
研究者
Andre Messias
PhD
University of Sao Paulo