Intravitreal Combination Therapy Using Triamcinolone and Bevacizumab Improves Vision in Patients With Diabetic Retinopathy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Best Corrected Visual Acuity
研究概览
简要总结
The aim of this pilot study was to investigate the effects of an intravitreal combination therapy using triamcinolone and bevacizumab in patients with macular edema due to diabetic retinopathy.
详细描述
This prospective, monocenter pilot case series was conducted between May 2006 and November 2008. Patients were included because of DME and signs of pre- and early proliferation because of diabetic retinopathy.73 eyes of 56 patients were included, all of which had signed an informed consent to perform a pharmacosurgical procedure consisting of a 23 gauge core Pars Plana Vitrectomy (sutureless single stitch sclerotomy, cutter with 300 cuts/minute) with removement of 1.5ml vitreous and substitution with 1ml BSS, 8mg triamcinolone, and 1.25 mg bevacizumab. At baseline and follow-up, the best corrected visual acuity (BCVA; 6 m Snellen), and intraocular pressure (IOP; Goldmann tonometry), and central macular thickness (optical coherence tomography) were determined. In addition, the need for further treatment and adverse events were monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of diabetic retinopathy
- •macular edema more than 200 micron
- •vitreous bleeding because of angiography documented NVEs NVDs, based on the definitions of ETDRS
排除标准
- •Prior intraocular injection within 4 months
- •Core or complete vitrectomy
- •History of glaucoma or ocular hypertension
- •Presence of iris neovascularization
- •Significant media opacity
- •Monocularity and pregnancy
研究组 & 干预措施
1
group I (n=17) nonproliferative DR and ischemic maculopathy
干预措施: triamcinolone and bevacizumab (Drug)
2
group II (n=38) nonproliferative DR without ischemic maculopathy
干预措施: triamcinolone and bevacizumab (Drug)
3
group III (n=18) proliferative DR with or without ischemic maculopathy
干预措施: triamcinolone and bevacizumab (Drug)
结局指标
主要结局
Best Corrected Visual Acuity
时间窗: Day of exam
次要结局
未报告次要终点
研究者
Michael Koss
PI
Johann Wolfgang Goethe University Hospital
