NCT04101877进行中（未招募）2 期
The Sahlgrenska Anti-VEGF (SAHLVE) Study - a Prospective Randomized Double-blind Comparison of Bevacizumab and Aflibercept in Patients With Neovascular Age-related Macular Degeneration
Vastra Gotaland Region1 个研究点 分布在 1 个国家目标入组 402 人开始时间: 2020年9月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 402
- 试验地点
- 1
- 主要终点
- Number of injections
研究概览
简要总结
The study investigates whether patients treated for neovascular (wet) age-related macular degeneration (AMD), with intravitreal injection with bevacizumab (Avastin) after two years need more injections with retained therapy response compared to patients being treated with intravitreal injection with aflibercept (Eylea).
The study also aims to evaluate if there is a difference in best-corrected visual acuity, macular thickness, recurrence interval, durability, cost efficiency, as well as vision-related quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
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
- •Signed informed consent.
- •≥50 years, regardless of gender.
- •Diagnosed with the neovascular (wet) form of age-related macular degeneration through diagnosed neovascular vascular membranes with OCT-A and, if necessary, also FA / ICG, according to clinical routine.
- •Distance visual acuity ≥34 (ETDRS) on the current study eye.
排除标准
- •Other eye disease in the current study eye that affects visual acuity or the possibility of examining fundus, according to the investigator's assessment.
- •Previously received treatment for the neovascular (wet) form of age-related macular degeneration.
- •Diagnosed with diabetes (all types).
- •Degenerative state of the macula that prevents vision improvement such as central areolar atrophy or other pronounced dry AMD or fibrosis, in the current study eye.
- •Other choroidal neovascularization (CNV) of the type PCV or due to grave myopia i.e. ≥ 6.0 diopters (D) or secondary to other retinal disease, in the current study eye.
- •Unregulated intraocular pressure (IOP) > 30 mmHg despite pharmacological treatment in the current study eye.
- •Have had a stroke or heart attack ≤6 months ago.
- •Inability to access information (e.g. due to dementia) or inability to conduct examinations (e.g. ETDRS examination), according to the investigator's assessment.
- •Inability to receive oral and written information in Swedish (in need of an interpreter).
- •Included in another intervention study.
- •Fertile woman i.e. a woman who has had menstruation for the past 12 months or has not undergone permanent sterilization (hysterectomy, bilateral salpingectomy or bilateral oophorectomy).
研究组 & 干预措施
Avastin
Experimental
bevacizumab 25 mg/ml, intravitreal administration, 0.05 ml (1.25 mg)
干预措施: Bevacizumab Injection (Drug)
Eylea
Active Comparator
aflibercept 40 mg/ml, intravitreal administration, 0.05 ml (2 mg)
干预措施: Aflibercept Injection (Drug)
结局指标
主要结局
Number of injections
时间窗: Two years
Number of intravitreal injections
次要结局
- Macular thickness (Central Retinal Thickness; CRT)(Two years)
- Intraocular pressure (IOP)(Two years)
- Best-corrected visual acuity (BCVA), distance(Two years)
- Best-corrected visual acuity (BCVA), near(Two years)
- Cost-benefit(Two years)
- Recurrence interval(Two years)
- Durability(Two years)
- Cost efficiency(Two years)
- Vision-related quality of life(Two years)
研究者
研究点 (1)
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