Study of Retinal and Vascular Features by Optical Coherence Tomography and Optical Coherence Tomography Angiography After Intravitreal Injections of Ranibizumab in Radiation Maculopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Study of retinal and vascular features in pazients affected by radiation maculopathy after intravitreal injections of Ranibizumab
研究概览
简要总结
This study evaluates the retinal and vascular features in patients with radiation maculopathy under the effects of Ranibizumab intravitreal injections using optical coherence tomography and optical coherence tomography angiography.
详细描述
The radiation maculopathy is a consequence of radiotherapy for treatment of choroidal melanoma. The radiation maculopathy is characterized by the compromission of the macular microvasculature that can lead to the leakage, lipid exudates, hemorrhages, teleangiectasie, macular edema, non perfusion areas with consequent significant impaiment of visual acuity.
Ranibizumab is a vascular endothelial growth factor antagonist and it represents an efficacy treatment acting on vascular hyperpermeability. The optical coherence tomography and optical coherence tomography angiography represent novel and non-invasive diagnostic techniques that allow a detailed analysis of retinal and vascular features. The study evaluates the changes in optical coherence tomography and optical coherence tomography angiography parameters at baseline and after intravitreal injections of Ranibizumab at the last follow up to one year in patients affected by radiation maculopathy.
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
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age older than 40 years
- •diagnosis of radiation maculopathy
- •treatment-naïve with Ranibizumab
- •absence of other vitreoretinal and vascular retinal diseases
排除标准
- •age younger than 40 years
- •No diagnosis of radiation maculopathy
- •previous treatments with Ranibizumab
- •presence of vitreoretinal and vascular retinal diseases
结局指标
主要结局
Study of retinal and vascular features in pazients affected by radiation maculopathy after intravitreal injections of Ranibizumab
时间窗: one year
The effectiveness of Ranibizumab injections for treating radiation maculopathy using optical coherence tomography (OCT). The parameter analyzed by OCT was: Central Macular Thickness (micron).
Study of retinal and vascular features in patients affected by radiation maculopathy after intravitreal injections of Ranibizumab
时间窗: one year
The effectiveness of Ranibizumab injections for treating radiation maculopathy using optical coherence tomography angiography (OCTA). The parameter analyzed by OCTA was: retinal vessel density (%)
次要结局
未报告次要终点
研究者
Gilda Cennamo
Principal Investigator
Federico II University