Long-Term Efficacy and Safety of Aflibercept Intravitreal Injections for the Treatment of Diabetic Macular Edema in Subjects Who Completed the Three Year VISTA-DME Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 主要终点
- Proportion of subjects receiving 0 aflibercept injections in 52 weeks
研究概览
简要总结
The Endurance Trial is a Phase IV open label clinical study to assess the need for ongoing intravitreal aflibercept injections after the 3-year VISTA DME (VGFT-OD-1009) endpoint. Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) based on the presence of CR-DME (Clinically Relevant-DME). In addition, subjects who meet re-treatment criteria will be eligible for focal laser treatment every 90 days
详细描述
The Endurance3 Trial is a Phase IV open label study to assess the need for ongoing intravitreal aflibercept injections after the 3 year VISTA DME (VGFT-OD-1009) endpoint. Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) upon the presence of CR-DME (Clinically Relevant DME) as noted by OCT (Optical Coherence Tomography) imaging and examination. In addition, subjects who meet the re-treatment criteria will be eligible for focal laser treatment every 90 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Enrolled and completed VISTA DME (VGFT-OD-1009) clinical trial
- •Willing and able to comply with clinic visits and study-related procedures
- •Provide signed informed consent
- •Enrollment in the trial within 12 weeks of trial activation
排除标准
- •Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline
- •Pregnant or breast-feeding women
- •Sexually active ment or women of childbearing potential who are unwilling to practice adequate contraception during the study
研究组 & 干预措施
Open-Label Arm
2mg Aflibercept, as needed, intravitreal administration.
All subjects will be treated with intravitreal (IVT) aflibercept injections as needed in the presence of clinically relevant diabetic macular edema (CR-DME). If CR-DME is not present the subject will not receive an IVT aflibercept injection and will be observed.
If a subject has recurrent CR-DME they will receive an IVT aflibercept 2.0 mg injection and interval between visits will be reduced to 4 weeks.
At week 12 through end of study, all subjects will be evaluated for focal laser treatment.
干预措施: Assigned Intervention (Procedure)
Open-Label Arm
2mg Aflibercept, as needed, intravitreal administration.
All subjects will be treated with intravitreal (IVT) aflibercept injections as needed in the presence of clinically relevant diabetic macular edema (CR-DME). If CR-DME is not present the subject will not receive an IVT aflibercept injection and will be observed.
If a subject has recurrent CR-DME they will receive an IVT aflibercept 2.0 mg injection and interval between visits will be reduced to 4 weeks.
At week 12 through end of study, all subjects will be evaluated for focal laser treatment.
干预措施: aflibercept 2.0 mg (Drug)
结局指标
主要结局
Proportion of subjects receiving 0 aflibercept injections in 52 weeks
时间窗: 12 months
Safety of ongoing aflibercept intravitreal injections as assessed by the incidence and severity of ocular and systemic adverse events
时间窗: 12 months
Mean number of intravitreal aflibercept injections in 52 weeks
时间窗: 12 months
Longer-term efficacy of aflibercept intravitreal injections as assessed by the mean number of injections in 52 weeks
时间窗: 12 months
次要结局
- Vision Change(12 months)
- Vision loss(12 months)
- Change in central retinal thickness(12 months)
- Evaluation of Diabetic Retinopathy (Proportion of subjects with stable, worsened, or improved diabetic retinopathy as identified by eye examination and imaging)(12 months)
- Ocular and systemic adverse events(12 months)
- Development of clinically relevant diabetic macular edema(12 months)
- Role of focal laser treatment in management of DME (Proportion of subjects that receive focal laser treatment and mean number of intravitreal aflibercept injections before and after receiving focal laser treatment)(12 months)