Anti-VEGF Therapy for Subfoveal Hemorrhage in Patients With Neovascular Age-Related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Correlation between hemorrhage characteristics and good visual outcome at month 12
研究概览
简要总结
This study will define the limits of subretinal hemorrhage parameters that are consistent with a good visual outcome with aggressive anti-VEGF treatment in patients with neovascular age-related macular degeneration (NVAMD).
详细描述
The purpose of this study is to define the limits of subretinal hemorrhage parameters that are consistent with a good visual outcome with aggressive anti-vascular endothelial growth factor (anti-VEGF) treatment, thereby providing guidance as to when it is reasonable to treat with anti-VEGF and when it is necessary to displace the hemorrhage in addition to treating with anti-VEGF.
This is a prospective study that will enroll 98 patients with subretinal hemorrhage in the fovea [also known as subfoveal hemorrhage (SFH)] secondary to neovascular AMD at the Wilmer Eye Institute, Johns Hopkins Hospital (Downtown campus and all other Eye Care Network clinics). The primary endpoint is at month 12 and the secondary endpoint is at month 24. The duration of the study is 24 months.
Study visits will include a baseline visit, then monthly visits for 12 months, followed by standard care treatment visits in the second year until month 24. The patients will be stratified into two groups based on standard of care management: 1. Patients receiving intravitreal (IVT) anti-VEGF injections; 2. Patients undergoing SFH displacement followed by IVT anti-VEGF injections. Patients will receive monthly anti-VEGF injection for 12 months, followed by anti-VEGF at standard of care treatment interval during months 12-24; or SFH displacement (at investigators' discretion) followed by monthly IVT anti-VEGF injections for 12 months, and standard of care treatment interval during months 12-24.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent and authorization of use and disclosure of protected health information
- •Age 50 years or older
- •Presence of subretinal hemorrhage (SRH) involving the fovea in patients with NVAMD including polypoidal choroidal vasculopathy (PCV)
排除标准
- •SFH in the study eye due to causes other than NVAMD
- •Media opacity due to concurrent vitreous hemorrhage or cataracts that preclude adequate imaging
- •Substantial loss of VA due to condition other than AMD
- •Limited visual potential from substantial atrophy or fibrosis in fovea
- •Poor visual potential with known permanent reduction in visual acuity prior to SFH
研究组 & 干预措施
Anti-VEGF injection only
Patients who will receive monthly intravitreal anti-VEGF injection for 12 months, followed by anti-VEGF at standard of care treatment interval during months 12-24
干预措施: Anti-VEGF (Drug)
Hemorrhage displacement + Anti-VEGF
Hemorrhage displacement (at investigators' discretion) followed by monthly intravitreal anti-VEGF injections for 12 months, and standard of care treatment interval during months 12-24
干预措施: Hemorrhage displacement + Anti-VEGF (Other)
结局指标
主要结局
Correlation between hemorrhage characteristics and good visual outcome at month 12
时间窗: 12 months
Correlation between baseline SFH characteristics measured on Spectralis SD-OCT (size and thickness of SFH, and shortest distance between border of SFH and fovea) and good visual acuity outcome (≥20/50) after controlling for baseline visual acuity in patients receiving monthly IVT anti-VEGF injections using pearson or spearman correlation coefficients based on normality of the data.
次要结局
- Correlation between hemorrhage characteristics and visual acuity at month 12(12 months)
- Correlation between hemorrhage characteristics and visual acuity at month 24(24 months)
- Correlation between hemorrhage characteristics and good visual outcome at month 24(24 months)