Detection and Management of Sinusitis in a Single-center Prospective Cohort of Patients With Exudative AMD (SINE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Estimate the prevalence of sinusitis in patients with bilateral multi-injected neovascular AMD (≥ 6 intravitreal injections per year in at least one eye)
研究概览
简要总结
An inflammatory component associated with AMD has been highlighted by genetic associations of predisposition to AMD, as well as by the recently demonstrated link between AMD and periodontitis.
Some patients followed at the Fondation Adolphe de Rothschild Hospital for wet AMD seemed to show an improvement of neovascular activity (less need for intravitreal injections of anti-VEGF) after treatment of their sinusitis.
The investigators would therefore like to assess the link between AMD and sinusitis, an infection close to the site of AMD.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patient followed and treated for at least 2 years for bilateral neovascular form of age-related macular degeneration (AMD)
- •At least one eye treated with ≥ 6 intravitreal injections during the year preceding preinclusion
- •Express consent to participate in the study
- •Affiliated with or beneficiary of a social security plan
排除标准
- •Persons referred to in articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of liberty by judicial or administrative decision, minors, and persons under legal protection: guardianship or curatorship).
- •Severe myopia (> 6 diopters)
- •Patient already being treated for acute or chronic sinusitis
- •History of central serous chorioretinopathy or diffuse retinal epitheliopathy
结局指标
主要结局
Estimate the prevalence of sinusitis in patients with bilateral multi-injected neovascular AMD (≥ 6 intravitreal injections per year in at least one eye)
时间窗: Day 0
Percentage of patients with bilateral multiinjected neovascular AMD (≥6 intravitreal injections/year in at least one eye) with sinusitis following ENT consultation screening. Sinusitis is defined by nasofibroscopic abnormalities showing sinus pathology (inflammation, polyp, rhinorrhea) and/or scannographically confirmed sinus filling (some sinusitis is blocked and therefore not externalized).
次要结局
- To compare, between patients screened and managed for sinusitis and those not requiring treatment for sinusitis, the evolution of the number of intravitreal injections(Month 15)