Phase 2 Study of Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Percentage of patients with regression of retinal neovascularization between baseline and 12th month.
研究概览
简要总结
Proliferative diabetic retinopathy is a serious complication of diabetes mellitus, partly consecutive to upregulation of vascular endothelial growth factor (VEGF) as a consequence of retinal ischemia leads. Aflibercept has been approved by FDA and European medicine agency for treatment of exudative age-related macular degeneration, another retinal disease characterized by choroidal new vessels.
The aim of this pilot study is to evaluate the efficacy and the safety of Aflibercept intravitreal injections compared to panretinal photocoagulation for proliferative diabetic retinopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
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
- •Patients with diabetes mellitus type 1 or type 2 complicated by PDR
- •Male or female over 18 years
- •HbA1c <11.6% at study entry
- •Systolic blood pressure <160 mmHg and diastolic blood pressure <105 mmHg at study entry
- •Backgrounds clear eye, pupil dilation and patient cooperation sufficient to allow examination or fundus photographs of good quality
排除标准
- •Hypersensitivity to aflibercept or to any of the excipients
- •History of retinal laser (macular or panretinal photocoagulation), of intravitreal injections, of vitrectomy in the eye studied
- •PDR associated with tractional retinal detachment in the eye studied
- •PDR associated with fibrovascular proliferation in the eye studied
- •Florid diabetic retinopathy
- •Eye infection or periocular active or suspected
- •Unbalanced glaucoma in the eye studied
- •Other eye disease in the eye studied
- •Patients with significant medical problems that may interfere with the evaluation of the safety or efficacy of the treatment studied
研究组 & 干预措施
Panretinal photocoagulation
干预措施: panretinal photocoagulation (Procedure)
Aflibercept intravitreal injections
干预措施: Aflibercept intravitreal injections (Drug)
结局指标
主要结局
Percentage of patients with regression of retinal neovascularization between baseline and 12th month.
时间窗: 12 months
次要结局
未报告次要终点