NCT03797547Unknown不适用
Real Life Study in Myopic Neovascularization
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- visual acuity measurement
研究概览
简要总结
This is a multi centre, single arm, prospective observational phase 4 study in naive or pretreated patients with myopic neovascularization. The patients will be treated with intravitreal injections of Aflibercept following a real life protocol.
This sudy aims to evaluate the visual acuity during a 36 months period of time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman aged 18 years and more under reliable method of contraception for woman with childbearing potenteial (hormonal or any intrauterine devices).
- •High myopy defined by refractive error ≤ -6 D or History of high myopia among pseudophakic patient or patient treated with refractive surgery
- •Patient with active CNVm
- •• Patients naïve or Patients pretreated with previous history of laser photocoagulation or PDT or by other anti-VEGF treatments who did not receive injection since the last 3 month
- •with OCT or angiography examination
排除标准
- •Treatment with an anti VEGF administrated by intravitreal injection within 1 months prior to baseline in the study eye.
- •Treatment with PDT or laser administrated within 6 months prior to baseline in the study eye.
- •History of vitrectomy in the study eye
- •History of any other retinal disease
- •VA less than 20/250
结局指标
主要结局
visual acuity measurement
时间窗: 6, 12, 24 and 36 months
Efficacy measurement will be performed by mean change of "ETDRS" for Best Corrected Visual Acuity evaluation (ETDRS score at 4 meters) from baseline to 6, 12, 24 and 36 month after initation of treatment by aflibercept
次要结局
- Anatomics parameters by color photographs(6, 12, 24 and 36 months)
- pourcentage of patients who gain more than or equal of 15 letters(6,12,24 and 36 months)
- visual acuity measurement in naive patient(12, 24 and 36 months)
- visual acuity measurement after other treatment such as laser, pdt visudyneor other IVT treatment(6, 12, 24 and 36 months)
- Anatomics parameters by oct(6, 12, 24 and 36 months)
- Anatomic parameters by fluoresceine angiography or angiography oct(6, 12, 24 and 36 months)
研究者
研究点 (1)
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