Investigation of the Maximal Treatment Interval and Long-term Remission and the Associated Factors of Neovascular AMD Treated With Anti-VEGF Using Treat and Extend Strategy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The percentage of patients whose maximum treatment interval is extended to 24 months
研究概览
简要总结
To evaluate the duration of effectiveness of anti-VEGF (Aflibercept) by analyzing the percentage of patients whose maximum treatment interval is extended to 16 weeks and beyond in 24 months and their long-term remission.
详细描述
This is an Observational, prospective, single arm study. The distribution of maximum treatment interval extended within 2 year among nAMD patients with Aflibercept Treat-and-Extend(T&E) regimen will be analyzed. And Clinical indicators for fast extension of treatment interval and emering disease activity will be captured.
To maximize Vision acuity (VA) outcome and reduce treatment burden of neovascular age-related macular degeneration (nAMD) patients, the T&E regimen has become popular in recent years. Sufficient drug durability is the key element to support T&E regimen. Clinical trials with aflibercept suggest a longer duration of VEGF suppression than with bevacizumab or ranibizumab, which is also supported by pharmacokinetic models, and mean duration of vitreous VEGF suppression by aflibercept injection was demonstrated as > 71 ± 18 days. With these attributes, while managed by intravitreal injection aflibercept (IVI-ALF) T&E regimen, it has been shown in ALTAIR study that around 40% and 60% of patients had treatment interval extended to 12 week and 16 weeks at week 96 respectively.
Nevertheless, it was observed that the distribution of treatment interval is polarized, a group of patients would eventually reach a stable disease status with only few treatments needed per year, while another group of patients may still need more intensive treatment even shorter than 8 week interval. To maximize benefit of patients with practical and personalized IVT-AFL T&E regimens, it is important to provided further evidence to support maximizing treatment interval as well as clinical indicators to take precise action to active disease. Therefore, this study is designed to understand the potential durability of Aflibercept by analyzing maximum treatment interval with IVT-AFL in 2 years, and explore clinical indicators to guide optimal T&E regimen for each patient.
Patients are treated with Aflibercept 2.0 mg following the T&E criteria in Taiwan local consensus (listed as below). Once the treatment interval is extended to 16 weeks, and the patient has two consecutive 16-week treatment interval, treatment strategy will be changed to pro re nata (PRN) with monthly follow-up. IVI-AFL will immediately be applied once there is any disease activity detected.
During the study, patients will be monitored with BCVA, fundus photograph, structural OCT, OCT Angiography.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •-Treatment-naïve patients with subfoveal CNV secondary to wet AMD and PCV, with visual impairment being exclusively due to an symptomatic neovascular AMD.
- •- -Clinical status meet the national reimbursement criteria
排除标准
- •- Any contraindications as listed in the local intravitreal aflibercept package insert
- •- Any active periocular or ocular infection or inflammation at baseline
- •- Uncontrolled glaucoma (intraocular pressure [IOP] ≥30 mm Hg on medication) at baseline
- •- Neovascularisation of the iris or neovascular glaucoma at baseline
- •- Visually significant cataract, severe vitreous haemorrhage, rhegmatogenous retinal detachment, proliferative diabetic retinopathy or CNV of any cause other than wet AMD at baseline
- •- Structural damage to the center of the macula in either eye that is likely to preclude improvement in VA following the resolution of macular edema or any other condition expected to permanently limit VA outcomes over the course of the study
结局指标
主要结局
The percentage of patients whose maximum treatment interval is extended to 24 months
时间窗: 2 years
次要结局
- The percentage of patients whose maximum treatment interval is extended to 16 weeks and beyond in 24 months in PCV and wAMD subgroup(2 years)
- Find the prediction factors associated with extension to 16 weeks and beyond by univariate and multivariate analysis(2 years)
- Find the prediction factors associated with occurrence of disease activity by univariate and multivariate analysis(2 years)
- Mean change in BCVA from baseline to month 24(2 years)
- Mean change in central subfield thickness from baseline to month 24(2 years)
- Proportion of patients who gain ≧15 ETDRS letters from baseline to month 24(2 years)
- Mean number of injections in each group from baseline to month 24(2 years)
- Mean treatment interval from baseline to month 24(2 years)