NCT02142296已完成4 期
A 12-month, Exploratory Open-label Study of Eylea (Aflibercept) in Subjects With Retinal Pigment Epithelial Detachment Secondary to Neovascular Age-related Macular Degeneration
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- efficacy of Eylea in patients with RPED
研究概览
简要总结
Primary Objectives:
To assess the efficacy of intravitreal administered Eylea in preventing visual loss in subjects with a retinal pigment epithelial detachment (PED) subtype of neovascular age-related macular degeneration (AMD) measured by mean change in BCVA at Month 12 compared to Baseline.
Secondary Objectives:
- To assess the safety and tolerability of repeated intravitreal administration of Eylea in subjects with the PED subtype of neovascular AMD for a period of 1 year
- To assess the effect of repeated intravitreal administration of Eylea on Central Subfield Thickness (CSFT), Central Subfield Volume (CSFV), and PED height and volume.
- To assess the effect of repeated intravitreal administration of Eylea on vision related quality of life in subjects with PED study type of neovascular AMD assessed using the NEI/VFQ-25 questionnaire
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
- 是
入选标准
- •Signed, informed consent.
- •Men and women greater than or equal to 55 years of age.
- •Recent development of RPED secondary to AMD.
- •ETDRS best corrected visual acuities of 20/40 to 20/320 (letter score of 73 to 25) in the study eye.
- •Willing and committed and able to return for all clinic visits and complete all study related procedures.
排除标准
- •Any prior treatment for neovascular AMD except dietary supplements or vitamins. (for patients in the treatment naïve group only)
- •Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.
- •Total lesion size greater than 12 disc areas.
- •Subretinal hemorrhage that is either 50% or more of the total lesion area or if the blood is under the fovea and is 1 or more disc areas in size in the study eye.
- •Scar or fibrosis making up greater than 50% of the total lesion in the study eye.
- •Scar, fibrosis or atrophy involving the center of the fovea.
- •Presence of a retinal pigment epithelial tear.
- •History of a vitreous hemorrhage within 4 weeks prior to initiation of the study.
- •Presence of other causes of choroidal neovascular membrane other than AMD.
- •History of clinical evidence of diabetic retinopathy, especially diabetic maculopathy or macular edema from other causes, including retinal vein occlusion or diabetes
- •Prior vitrectomy surgery in the study eye.
- •History of retinal detachment treatment in the study eye.
- •History of macular hole in the study eye.
- •Any intraocular/periocular surgery within 3 months of the initiation of the study.
- •Prior trabeculectomy or filtering surgery in the study eye.
- •Uncontrolled glaucoma, defined as a pressure greater than 25 mmHg despite treatment.
- •Active intraocular inflammation.
- •Active ocular/periocular infection.
- •Any history of uveitis.
- •Active scleritis or episcleritis.
- •Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of YAG posterior capsulotomy) in the study eye.
- •Previous radiation therapy in the region of the study eye.
- •History of corneal transplant or corneal dystrophy in the study eye.
- •Significant medial opacities including cataract that may interfere with visual acuity or fundus photography.
- •Any disease or ocular condition which, in the opinion of the investigator could either increase in the risk to the subject beyond what is expected from a standard procedure of intraocular injections or which may be considered contraindicated for the use of the investigational drug (VEGF Trap).
- •The use of long acting steroids systemically or intraocularly.
- •Any history of allergy to Proviodine or fluorescein sodium.
研究组 & 干预措施
Eylea
Other
The intravitreal dose of Eylea will be 2mg (50ul) per injection. The medication will be supplied in single use vials. Given monthly for 3 months and then every 8 weeks until week 52. This is an open-label study.
干预措施: Eylea (Drug)
结局指标
主要结局
efficacy of Eylea in patients with RPED
时间窗: baseline to month 12
visual acuity mean change from baseline compared to month 12
次要结局
- safety and tolerability of repeated Eylea injection(period of 1 year)
- effect of repeated Eylea injections of Central Subfield Thickness , Central Subfield Volume and PED height and volume(baseline to month 12)
- effect of repeated Eyle injections on vision related quality of life(baseline to month 12)
研究者
John Gonder
Principal Investigator
Lawson Health Research Institute
研究点 (1)
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