A REtrospective Non-interventional Study to Assess the Effectiveness of AfLibercept in Patients With Myopic CNV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in best corrected visual acuity (BCVA) from baseline to 6 months
研究概览
简要总结
Being short sighted means that vision is blurry when looking at things far away. People with a condition called "pathologic myopia" are short sighted due to problems in the back layer of their eyes, also known as the retina. Some people with pathologic myopia can develop a serious condition called myopic choroidal neovascularization (mCNV). In people with mCNV, new blood vessels grow into the retina. These blood vessels can break, leaking blood or fluid into the retina. This can cause blurry vision or a loss of vision.
In this study, researchers will find out more about how well drug aflibercept works and how safe it is in Canadian patients with mCNV.
The researchers in this study will review information from the patients' eye doctor visits. The patients in this study will include Canadian men and women who started receiving aflibercept between May 2017 and August 2019. These patients were at least 18 years old and had not received treatment for their mCNV before.
The researchers will look at the results of vision tests to find out how well the patients could read from a distance after they received aflibercept for 6 months. They will compare the results of these tests to before the patients received treatment. They will also learn more about how safe it is to have aflibercept injection into the eye.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adult (Age ≥ 18 years) female or male patient.
- •Anti-VEGF treatment naïve patients diagnosed with mCNV.
- •Initiation of treatment with aflibercept was made as per investigator's routine treatment practice between 01 MAY 2017 and 31 AUG 2019.
排除标准
- •Any participation in an investigational program with interventions outside of routine clinical practice.
- •Patients who have previously been treated with anti-VEGF intravitreal injections, systemic anti-VEGF or pro-VEGF treatments, as well as other intravitreal steroids or steroid implants for the study eye.
- •Patients with another retinal disease (e.g. wet age-related macular degeneration,-wAMD; diabetic macular edema-DME; retinal vein occlusion-RVO), patients with advanced cataracts or glaucoma, or patients with scarring, fibrosis, or atrophy involving the center of the fovea.
研究组 & 干预措施
mCNV patients
Adult Canadian patients diagnosed with myopic choroidal neovascularization (mCNV) and naïve for anti-VEGF treatment
干预措施: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) (Drug)
结局指标
主要结局
Change in best corrected visual acuity (BCVA) from baseline to 6 months
时间窗: Baseline to 6 months
BCVA is assessed by ETDRS (Early Treatment Diabetic Retinopathy Study) or Snellen chart with conversion to ETDRS.
次要结局
- Change in BCVA from baseline to 12 months(Baseline to 12 months)
- Central retinal thickness (in μm) measured by Optical coherence tomography (OCT)(At baseline, 6 and 12 months)
- Number of treatment-emergent adverse events (TEAS's)(Baseline to 12 months)
- Severity of treatment-emergent adverse events(Baseline to 12 months)
- Time from diagnosis to first treatment(At 12 months)
- Number of aflibercept treatments(At 12 months)
- Number of clinic visits(At 12 months)
- Number of visual acuity tests performed(At 12 months)
- Number of imaging assessments performed(At 12 months)
- Type of imaging assessments performed(At 12 months)