NCT02634970撤回4 期
CANadian Study in Patients With Wet AMD, Evaluating the Efficacy and Safety of Switching From Intravitreal Aflibercept to RanIbizumab
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Mean change in Central Subfield Retinal Thickness (CSRT)
研究概览
简要总结
There are limited prospective data regarding the potential benefit and risks associated with switching between anti-VEGF therapies in patients with nAMD who have initially achieved a favorable response to the first anti-VEGF therapy used but subsequently have evidence of increasing disease activity despite continuation of therapy. This study will fill this knowledge gap by prospectively evaluating the effectiveness and safety of switching from aflibercept to ranibizumab in nAMD patients that have non - sustained response to initial treatment with aflibercept.
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
- •BCVA ≥23 ETDRS letters in study eye at both the Screening and Baseline visits.
- •Evidence, at Screening, of active, angiographically confirmed Choroidal Neovascularization (CNV) secondary to AMD, directly or indirectly affecting the center of the fovea in study eye.
- •No prior anti-VEGF treatment other than aflibercept.
排除标准
- •History of cerebrovascular accident, transient ischemic attack or myocardial infarction within 3 months of the Screening visit.
- •Any type of systemic disease or its treatment, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk.
- •Exclusion criteria for ocular medical history and conditions for either eye:
- •Any active periocular or ocular infection, or active intraocular inflammation at the time of Screening or Baseline (as per contraindications in the Lucentis® Product Monograph).
- •Uncontrolled glaucoma (intraocular pressure [IOP] ≥30 mm Hg on medication or according to Investigator's judgment) at the time of Screening or Baseline
- •Evidence of bilateral active CNV during the Screening Period or at Baseline requiring bilateral anti-VEGF injections.
- •Prior intravitreal injection of ranibizumab or bevacizumab into the study eye and/or prior intravitreal injection of bevacizumab into the fellow eye.
- •Study eye exclusion criteria:
- •At Baseline, intraocular surgery was performed within the previous 28 days or intraocular surgery is planned at any time during the 6 month study period
- •Cataract (if causing significant visual impairment), aphakia, severe vitreous hemorrhage, rhegmatogenous retinal detachment, proliferative retinopathy or choroidal neovascularization of any other cause than wet AMD (e.g. ocular histoplasmosis, pathologic myopia (≥-8 dioptres)) at the time of Screening and Baseline.
- •Irreversible structural damage involving the center of the fovea (e.g. advanced fibrosis or geographic atrophy) which in the opinion of the Investigator is sufficient to irreversibly impair visual acuity.
- •Polypoidal choroidal vasculopathy (PCV), RPE tear, central serous retinopathy (CSR), or significant vitreomacular traction identified during Screening period or within 4 months of Baseline visit. Note that small vitreomacular adhesions that do not result in deformity of the retina are permitted.
研究组 & 干预措施
Ranibizumab at 0.5 mg
Experimental
Single arm, intravitreal injection
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Mean change in Central Subfield Retinal Thickness (CSRT)
时间窗: at Day 90 (Month 3) and Day 180 (Month 6)
Change (in absolute and percentage terms) in central subfield retinal thickness (CSRT) measured by spectral domain/ high definition optical coherence tomography (SD/HD-OCT).
次要结局
- Mean change in Subretinal Fluid (SF)(Monthly, from baseline to Month 6)
- Mean change in Intra-Retinal Cystoid changes (IRCs) volume(Monthly, from baseline to Month 6)
- Mean change in Pigment Epithelial Detachments (PEDs)(Monthly, from baseline to Month 6)
- Mean change of Best-Corrected Visual Acuity (BCVA)(Monthly, from baseline to Month 6)
- Rate of change in Subfoveal Retinal Thickness (SRT)(Monthly, from baseline to Month 6)
- Rate of change in Central Subfield Retinal Thickness (CSRT)(Monthly, from baseline to Month 6)
- Rate of change in Intra-Retinal Cystoid (IRCs)(Monthly, from baseline to Month 6)
- Rate of change in Pigment Epithelial Detachments (PEDs)(Monthly, from baseline to Month 6)
- Mean change in Central Subfield Retinal Thickness (CSRT)(Monthly, from baseline to Month 6)
- Rate of Dry Retina(Monthly, from baseline to Month 6)
- Mean change in Subfoveal Retinal Thickness (SRT)(Monthly, from baseline to Month 6)
- Change in Central Subfield Retinal Volume (CSRV)(Monthly, from baseline to Month 6)
研究者
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