High Dose (HD) Aflibercept Switch in Neovascular Age-related Macular Degeneration (nAMD): to Load or Maintain (HEIRLOOM)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Central Retinal Thickness (CRT)
研究概览
简要总结
The purpose of this study is to compare two treatment frequencies using EYLEA® HD (aflibercept 8mg) in patients with wet age-related macular degeneration (wAMD) that are currently treated with EYLEA® (aflibercept 2mg).
EYLEA® HD is approved by Health Canada has been tested in large clinical trials involving thousands of patients around the world and has been shown effective in the treatment of wAMD. The treatment regimen used in these trials involved 3 initial monthly injections of EYLEA® HD followed by an extension of the treatment interval on the 4th visit. This was necessary since all patients in this study did not previously have treatment injections for wAMD.
Currently there is not enough information on the best treatment regimen to use for patients that are switched to EYLEA® HD from EYLEA®.
Health Canada currently recommends that EYLEA® HD is administered every month for the first 3 doses, followed by a treatment every 8 to 16 weeks.
A total of 180 patients >18 years of age will participate in this study, which will be conducted at the Clinique de Retine de l'Est in Montreal, Quebec, Canada.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over the age of 18
- •Patients with neovascular AMD
- •Patients who have received aflibercept 2mg for a minimum of 3 loading injections plus 2 maintenance injections.
- •Can include 1 or 2 eyes per patient if one or both meet study criteria.
排除标准
- •Patients with other maculopathy, including but not limited to:
- •Polypoidal choroidal vasculopathy
- •Macular dystrophies (ie. Pattern dystrophy, central areolar etc.)
- •Toxic/drug induced maculopathies
- •Disciform scar
- •Subfoveal atrophy
- •Previous Photodynamic Therapy (PDT) or focal laser
- •Is currently enrolled in another clinical study or observational study
- •Active use of a different agent in the fellow eye, to avoid cross-over effects of anti Vascular Endothelial Growth Factor (VEGF) administration to the fellow eye
- •If the patient is pregnant
研究组 & 干预措施
Loading interval group
patients who are currently being treated with EYLEA® (aflibercept 2mg) will be switched to EYLEA® HD (aflibercept 8mg) and receive injections every month for the first 3 months followed by an extension (or increase in dosing interval) of therapy based on clinical response. This is the "on label" treatment regimen approved by Health Canada.
Maintenance interval group
patients who are currently being treated with EYLEA® (aflibercept 2mg) will be switched to EYLEA® HD (aflibercept 8mg) and maintain the current treatment interval that they had with EYLEA® (aflibercept 2mg), followed by an extension of therapy (or increase in treatment dosing interval) based on clinical response. This is the "off-label" treatment regimen that we are testing to see if it is as effective and involves less treatment burden.
干预措施: Maintenance (Other)
结局指标
主要结局
Central Retinal Thickness (CRT)
时间窗: 6 and 12 month
The primary endpoint will derived from Optical Coherence Tomography (OCT), in µm and measured at 12 months after switching therapies with interim analysis at 6 months (Detected on 8 line radial scans, through the fovea).
次要结局
- Visual Acuity(6 and 12 month)
- Number of injections(6 and 12 month)
- Adverse events(6 and 12 month)
- Presence of Subretinal Fluid (Yes/No)(6 months and 12 months)
- Presence of Intraretinal Fluid (Yes/No)(6 months and 12 months)
- Pigment Epithelial Detachment (PED) Type(6 months and 12 months)
- Pigment Epithelial Detachment (PED) Height(6 months and 12 months)
研究者
Dr. Andrei Szigiato
Principal Investigator
Clinique de Retine de l'est