Cytokeratin 8 Level in Aqueous Humor, as a Prognostic Factor for Visual and Anatomical Outcomes After Ranibizumab (Lucentis) in Neovascular Age-related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- The changes in the Logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity
研究概览
简要总结
The investigators will evaluate the concentrations of cytokeratin 8 in aqueous humor in eyes with exudative age-related macular degeneration (AMD) before therapy with intravitreal Ranibizumab, and identify associations with visual and anatomical outcome after treatment.
详细描述
In this non-randomized, and open-label study, the investigators will prospectively evaluate 58 patients with treatment naive exudative age-related macular degeneration (AMD) who receive intravitreal ranibizumab injection. A mean volume of 0.1 ml of aqueous humor samples will be taken each time an intravitreal injection is indicated and performed. Cytokeratin 8 level in aqueous humor will be evaluated, and associations of baseline cytokeratin 8 level and visual (the best corrected visual acuity change) and anatomical (optical coherence tomography parameters) after Ranibizumab injection will be investigated.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment-naive neovascular AMD patients requiring intravitreal injection of Ranibizumab
- •A recent onset of disease confirmed by history and clinical findings.
- •Patient is required to be least 50 years of age
排除标准
- •Myopia with a refractive error >-3.0 diopters or evidence of pathologic myopia (pre-operative refractive data were used to assess pseudophakic eyes)
- •Any history of vitrectomy, anti-VEGF therapy, or photodynamic therapy (PDT)
- •History of cataract surgery within 3 months prior to presentation
- •Evidence of end-stage AMD such as subfoveal fibrosis or atrophy
- •Evidence of other retinal diseases including central serous chorioretinopathy and other neovascularmaculopathies; glaucoma; poor imaging data caused by media opacity; or unstable fixation
- •Patients with uncontrolled systemic diseases, use of immunosuppressive drugs, or malignant tumors of any location
研究组 & 干预措施
Ranibizumab
Intravitreal Ranibizumab
干预措施: Ranibizumab (Drug)
结局指标
主要结局
The changes in the Logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity
时间窗: From baseline to one month after three monthly consecutive ranibizumab injection
The changes in the Logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity
次要结局
- The presence of intra/subretinal fluid on Spectral domain (SD)- Optical Coherence Tomography (OCT)(From baseline to one month after three monthly consecutive ranibizumab injection)
研究者
Suk Ho Byeon
Professor
Gangnam Severance Hospital