Study Comparing Early Extension of Aflibercept and Brolucizumab in Wet AMD (SPARROW)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of injections given until week 52
研究概览
简要总结
The currently widely established and preferred protocol for the treatment of wet age-related macular degeneration includes a loading phase of three monthly injections without interim adaptation or treatment according to disease activity, thereafter following a T&E strategy with treatment adaptation in increments of 2-4 weeks according to disease activity. Based on pharmacological considerations regarding the vitreal half-life of the drugs, the aim of this prospective explorative study is to test whether an early extension of treatment intervals without a loading phase is an option without compromising functional outcomes. Based on a superiority of Afl compared to Ran with regard to achieving a dry retina after one year and based on studies, but in the absence of real-life experience with Bro, it seems of interest to test how far Afl and Bro are comparable in terms of their potential to extend the treatment intervals over 12 months, the time to dryness of the retina, and number of injections. Also, it is of high clinical relevance to demonstrate efficacy with longer initial treatment intervals compared to the current possibly over-treating loading-phase with three four-weekly injections.
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
- Double (Participant, Investigator)
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
- •Active MNV secondary to nAMD, going along with clinically significant vision loss
- •Patients aged 50 years or older of all sexes
- •Presence of IRF and/or SRF and/or subretinal hyperreflective material affecting the central subfield of the study eye on OCT
- •signed informed consent for this study prior to the screening visit
- •If possible: availability of a smartphone and willingness to perform self-testing with the Alleye app (soft criteria)
排除标准
- •Any other cause of macular oedema
- •Structural damage to the macula precluding a visual potential
- •Optical media opacities not allowing an accurate performance of the protocol examinations
- •Any intraocular surgery within three months prior to inclusion and history of any vitreoretinal surgery
- •Advanced diabetic retinopathy potentially requiring any treatment within six months following inclusion or history of vitreal haemorrhage
- •Presence of vitreoretinal traction or tractive epiretinal membrane affecting the fovea
- •History of IVT with anti-VEGF or corticosteroids at any time in the study eye
- •Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc.
- •Significantly worse functional prognosis in the other eye or only eye
- •Women of childbearing potential not willing to use an effective method of contraception during treatment and until at least 3 months after the last treatment
- •Pregnant or lactating women
- •Any systemic auto-inflammatory and auto-immune disease requiring treatment
- •Treatment with high-dose corticosteroids (Prednisone equivalent >5mg/day), immunosuppressive or immunomodulatory or anti-proliferative agents for any reason
- •Inability or contraindications to undergo the investigated intervention
研究组 & 干预措施
Aflibercept ® rapid treatment extension (T&E)
Early treat and extend (T&E) with Aflibercept ®. First IVT followed by control after 3 weeks and 2nd IVT after 6 weeks (= shortest treatment interval). Treatment will be adjusted according to morphologic response by adaptation of treatment intervals in +/- two-week increments.
干预措施: Aflibercept (Drug)
Aflibercept ® rapid treatment extension (T&E)
Early treat and extend (T&E) with Aflibercept ®. First IVT followed by control after 3 weeks and 2nd IVT after 6 weeks (= shortest treatment interval). Treatment will be adjusted according to morphologic response by adaptation of treatment intervals in +/- two-week increments.
干预措施: early treat and extend (T&E) (Procedure)
Brolucizumab ® rapid treatment extension (T&E)
Early treat and extend (T&E) with Brolucizumab ®. First IVT followed by control after 3 weeks and 2nd IVT after 6 weeks (= shortest treatment interval). Treatment will be adjusted according to morphologic response by adaptation of treatment intervals in +/- two-week increments.
干预措施: Brolucizumab (Drug)
Brolucizumab ® rapid treatment extension (T&E)
Early treat and extend (T&E) with Brolucizumab ®. First IVT followed by control after 3 weeks and 2nd IVT after 6 weeks (= shortest treatment interval). Treatment will be adjusted according to morphologic response by adaptation of treatment intervals in +/- two-week increments.
干预措施: early treat and extend (T&E) (Procedure)
结局指标
主要结局
Number of injections given until week 52
时间窗: 52 weeks
number injections received by patient
次要结局
- Number of treatment failures(104 weeks)
- Injections until week 104(104 weeks)
- Change in central subfield thickness (CST)(104 weeks)
- Time until drying of retina(104 weeks)
- portion of eyes without disease activity(104 weeks)
- Change in visual acuity(104 weeks)
- eyes under treatment intervals of ≥12 weeks(104 weeks)
- Portion of eyes gaining and loosing ≥5, ≥10, and ≥15 letters(104 weeks)
- Maximal treatment interval extension(104 weeks)