FUSION Regimen: A Disease Activity Guided Treatment Algorithm With Ranibizumab in naïve Subjects With Exudative Age-related Macular Degeneration
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- mean VA change
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of a combined fixed-interval and a pro re nata (PRN) regimens of ranibizumab (FUSION regimen) for the treatment of exudative age-related macular degeneration (AMD) in patients with good visual acuity (VA) at baseline. To establish whether similar efficacy to monthly regimens can be achieved with fewer injections, even in patients with good VA.
详细描述
This is a prospective, open-label, consecutive interventional case series in treatment-naïve patients with exudative AMD. A loading phase of 2-3 injections is followed by a fixed-interval regimen of injections combined with a pro re nata regimen for 12 months. Endpoints include VA, presence of fluid at spectral domain optical coherent tomography (SD-OCT), adverse events and number of injections administered.
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
- •subfoveal or juxtafoveal CNV owing to AMD, defined by fluorescein angiography (FA)
- •presence on SD-OCT of subretinal or intraretinal fluid associated or not with macular edema
- •Best corrected visual acuity (BCVA) in the study eye between 20/20 and 20/125, inclusive
- •total area of the lesion (including blood, neovascularization and scar/atrophy) of ≤8 disc areas, of which at least 50% must be active choroidal neovascularization (CNV) (defined as the neovascular component of the lesion as defined by FA
- •all angiographic subtypes [predominantly classic, minimally classic and occult] were eligible)
- •clear ocular media and adequate pupillary dilatation to allow collection of fundus photographs and FA of a sufficient quality to be analyzed
- •intraocular pressure of 21 mmHg or less
- •and no previous treatment for AMD
排除标准
- •presence of scarring or atrophy >75% of the total lesion size (patients with subfoveal scar or atrophy were excluded)
- •subretinal haemorrhage >75% of the total lesion size; presence of serous retinal pigment epithelial detachments >5 disc areas
- •presence of intraocular inflammation (≥ trace cell or flare), epiretinal membrane, macular hole or vitreous haemorrhage
- •history of idiopathic or autoimmune-associated uveitis in either eye
- •significant media opacities, including cataract, which might interfere with VA, assessment of toxicity or fundus photography in the study eye
- •presence of other causes of CNV, including pathological myopia (spherical equivalent of -3 diopters or more, or axial length of 25 mm or more, or fundus findings suggestive of pathologic myopia), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis
- •any retinal treatment (aside from antioxidants), including (but not limited to) intravitreal injections, photodynamic therapy with verteporfin, laser photocoagulation or surgery
- •history of rhegmatogenous retinal detachment, pars plana vitrectomy or corneal transplant
- •and previous radiation in the region of the study eye.
研究组 & 干预措施
ranibizumab
干预措施: Ranibizumab (Drug)
结局指标
主要结局
mean VA change
时间窗: 12 months
change in ETDRS (early treatment diabetic retinopathy study) letters from baseline to 12 month-visit
次要结局
- The percentage of patients losing <5, <15 and <30 ETDRS letters(12 months)
- The mean VA(6 and 12 months)
- The mean number of injections(12 months)
- Percentage of patients with gain of ≥5, >10 and ≥15 letters ETDRS(12 months)
- The median VA(12 months)
研究者
Jordi Mones
Director
Institut de la Macula y la Retina