NCT03783832Unknown不适用
Follow up of Diabetic Macular Edema Treated by Aflibercept (Eylea®) With OCT-Angiography
Aquitania Opthalmologica6 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2018年6月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 48
- 试验地点
- 6
- 主要终点
- Quantitative data from OCT angiography
研究概览
简要总结
This is a non-interventional, longitudinal, retrospective and prospective, non-controlled, single arm study in naive or non-naive patients with diabetic macular edema for which aflibercept (EYLEA®) therapy is indicated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Man or woman aged 18 years and more under reliable method of contraception for woman with childbearing potential (hormonal or any intrauterine devices).
- •Patients with type I or II diabetes (as defined by criteria of American diabetes association ADA or world health organization WHO) with an glycosylated hemoglobin rate (HbA1c) < 10.0%, at initial visit (First EYLEA® injection).
- •Patients with diabetes treatment unchanged within the last 3 months prior to initial visit (First EYLEA® injection).
- •Patients showing a visual lost due to a diabetic macular edema (DME) in the central region and not for another reason, assessed by the investigateur. The visual acuity of the fellow eye is not an exclusion criteria.
- •Patient to whom a treatment by aflibercept is indicated and OCT-angiography is performed at each injection visit.
- •Patients affiliated to social security system.
- •Patient who has been given appropriate information about the study objectives and instructions who has given his/her non-opposition prior to conduct any study-related procedures and examination.
- •Non iclusion Criteria:
- •Treatment with an anti VEGF (EYLEA®, LUCENTIS® or AVASTIN®) administrated by intravitreal injection within 3 months prior to initial visit in the study eye
- •Treatment with Ozurdex® administrated by intravitreal injection within 6 months prior to initial visit (First EYLEA® injection) in the study eye
- •History of or active ocular /intraocular inflammation (Uveitis) at initial visit (First EYLEA® injection), in either eye
- •Intra-ocular pressure ≥ 25 mmHg
- •Patient with neocascular glaucoma history
- •Patient with foveolar exsudat that interfere with images analysis.
- •History or current evidence of hypersentivity to mydriatic eye drops
- •Vitreomacular traction in the study eye
- •Panretinal coagulation within 3 months prior to initial visit (First EYLEA® injection), in the study eye.
- •Cataract surgery in the study eye within the 6 months prior to initial visit (First EYLEA® injection)
- •History of vitretectomy in the study eye
- •Treatment with systemic anti VEGF medications for cancer
- •History of cerebrovascular accident within 3 months prior to initial visit (First EYLEA® injection), renal failure, uncontrolled arterial hypertension (PAS>160 mm Hg and/ or PAD>100 mm Hg)
- •Patient who does not meet the local indication criteria for Eylea® treatment. Contraindications listed in the SmPCs must be taken into account
- •Participation in any investigational study with exclusion period in progress at the initial visit (First EYLEA® injection)
- •Patients under guardianship
- •Pregnant or breastfeeding woman.
排除标准
- 未提供
结局指标
主要结局
Quantitative data from OCT angiography
时间窗: 1 Year
The vascular density assessment (%) measured by OCT angiography
次要结局
未报告次要终点
研究者
研究点 (6)
Loading locations...
相似试验
已完成
4 期
Treatment of Diabetic Macular Edema With Aflibercept in Subjects Previously Treated With Ranibizumab or BevacizumabMacular EdemaDiabetic RetinopathyNCT02559180Rishi Singh20
尚未招募
不适用
Pilot study: Image-based, Diabetic macular Edema, Adjustment of Laser treatment - trial.diabetic retina changes10015917NL-OMON30395Academisch Medisch Centrum20
已完成
不适用
Describing Patient With DME, Their Patient Journey and Disease ProgressionDiabetic Macular EdemaNCT05966753Boehringer Ingelheim221,004
已完成
不适用
Aflibercept for Diabetic Macular Edema In Real-life Practice in GREeceDiabetic Macular EdemaNCT05683912University of Athens100
Unknown
4 期
Treat-and-extend Regimen of Aflibercept in Diabetic Macular Edema (VIBIM Study)Macular Edema, DiabeticNCT02788877Pusan National University Hospital48