Intravitreal Ranibizumab or Aflibercept After Bevacizumab in Diabetic Macular Edema
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
- Anatomical change
研究概览
简要总结
PURPOSE: To evaluate the efficacy of switching from bevacizumab to ranibizumab (Lucentis; Genentech, South San Francisco, CA) or aflibercept (Eylea; Regeneron, Tarrytown, NY) in eyes with diabetic macular edema (DME) nonresponders to bevacizumab (Avastin; Genentech, South San Francisco, CA).
METHODS: Single-center retrospective comparative study of patients with DME unresponsive to intravitreal bevacizumab that were switched to ranibizumab or aflibercept. Best-corrected visual acuity and central foveal thickness will be analysed prior to and 3 months after the switch. OCT biomarkers will also analyzed.
A p value of 0.05 or less will be considered to be statistically significant. HYPOTHESIS: Patients will improve anatomically and functionally after switch.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 1 or type 2 diabetes mellitus patients
- •older than 18 years
- •with center-involved DME, defined as central subfield thickness (CST) of more than 300 µm on spectral-domain OCT (SD-OCT).
- •nonresponsive to bevacizumab, defined as having persistent intraretinal and/or subretinal fluid on optical coherence tomography (OCT), i.e CSF>300µm after a minimum of 3 monthly injections, 4 months before switch, regardless of visual acuity (VA).
排除标准
- •additional ocular diseases that could significantly affect the visual acuity such as:
- •significant vitreoretinal interface abnormality on SD-OCT that may contribute to macular edema
- •age-related macular degeneration
- •retinal vascular occlusion
- •central corneal opacity
- •amblyopia
- •advanced glaucoma
- •optic neuropathy
- •history of ocular trauma or surgery other than uncomplicated cataract extraction
- •cataract surgery within 3 months before or after bevacizumab switch
- •unable to provide written informed consent.
研究组 & 干预措施
ranibizumab
Patients nonresponsive to bevacizumab that were switched to ranibizumab
干预措施: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS] (Drug)
aflibercept
Patients nonresponsive to bevacizumab that were switched to aflibercept
干预措施: Aflibercept 40 MG/ML Intraocular Solution [EYLEA] (Drug)
结局指标
主要结局
Anatomical change
时间窗: Immediately before switch (one month after last bevacizumab intravitreal injection); 4 months after switch. Minimum of three intravitreal injections before and after switch.
The central foveal thickness (CFT), measured by Optical Coherence Tomography, was automatically measured by the software in the central 1 mm. A CFT \<250 µm or \>300 µm is considered pathological. A CFT between 200 and 300 µm is considered physiological. CFT has no defined minimum or maximum values. Since patients with diabetic macular edema usually have CFT \>300 µm the goal of treatment is to lower the CFT to values between 200 and 300 µm. A clinical significant anatomical improvement was considered for a change in CFT≥10%.
Functional change
时间窗: Immediately before switch (one month after last bevacizumab intravitreal injection); 4 months after switch. Minimum of three intravitreal injections before and after switch.
Functional change was measure by the Early Treatment Diabetic Retinopathy Scale (ETDRS) which measures the best-corrected visual acuity with an ETDRS-like chart at 4 meters in number letters or at 1 meter when patients are unable to read any letters on the ETDRS chart at 4 meters. The ETDRS scale varies from 1 to 85 letters (85 letters correspond to a 20/20 in the Snellen scale). The higher the value the better the outcome. A clinical significant functional improvement was considered for a gain of ≥5 EDTRS letters.
次要结局
未报告次要终点
研究者
Bernardete Pessoa MD
Ophthalmologist
Centro Hospitalar do Porto