Functional, Morphological And Safety Results After Intravitreal Bevacizumab Treatment Of Neovascular Age-related Macular Degeneration - 3 Years Of Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 主要终点
- Vision
研究概览
简要总结
200 eyes with each subtype of neovascular age-related macular degeneration will be included in this study and 3 years after the initial intravitreal bevacizumab, best-corrected visual acuity (BCVA) will be measured using Snellen charts at 6m. Central retinal thickness (CRT) will be measured using Stratus OCT and Cirrus SD-OCT (Zeiss). Data of treatment-naive eyes (group 1) were compared to the data of eyes that had undergone prior treatment with photodynamic therapy with verteporfin and intravitreal triamcinolone acetonide (group 2).
详细描述
In this interventional clinical study, 181 eyes of 160 consecutive patients with active neovascular related macular degeneration meeting recommended criteria for inclusion and protocol criteria for anti-vascular endothelial growth factor therapy undergoing intravitreal bevacizumab monotherapy were evaluated. Data of treatment-naive eyes (Group 1, n = 114) were analyzed separately from eyes that had undergone previous photodynamic therapy plus intravitreal triamcinolone (Group 2, n = 67). Re-treatment criteria were based on clinical outcome following the official European label regimen. After 1 year of continuous service at an academic referral center, follow-up was performed in private practices in collaboration with the referral center. Main outcome parameters were best-corrected visual acuity and central retinal thickness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •any subtype of neovascular age-related macular degeneration
- •age of 50 years or older
- •initial treatment with intravitreal bevacizumab between August 2005 and June 2006
排除标准
- •previous vitrectomy
- •presence of cystoid macular edema without choroidal neovascularization
- •Uncontrolled systemic disease
研究组 & 干预措施
group 1
bevacizumab intravitreal injection
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Vision
时间窗: 3 years after first intravitreal bevacizumab treatment
Best-corrected visual acuity converted to logMAR (MAR=minimum angle of resolution) for statistical analysis
CRT (Central Retinal Thickness)
时间窗: 3 years after initial intravitreal bevacizumab treatment
Central retinal thickness measured in µm
次要结局
- Systemic Complications After Treatment(3 years after initial bevacizumab treatment)
研究者
Stefan Sacu
Assoc. Prof. Dr.
Medical University of Vienna