ACTRN12618000428268已完成4 期
A Prospective, unmasked, study to assess the effectiveness of a treat and extend regimen of aflibercept, for the treatment of diabetic macular oedema, in a clinical setting
itin Verma0 个研究点目标入组 26 人开始时间: 2018年3月26日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Written informed consent must be obtained prior to any study measures being performed
- •Male or female participants aged 18 years and over, with type 1 or type 2 diabetes mellitus
- •Female patients of childbearing potential should be counselled on potential risks and should use effective contraceptive measures during treatment and for up to three months after treatment ceases.
- •Diagnosis of diabetic macular oedema (DME) with central macular involvement in study eye diagnosed by fluorescein angiography.
- •Decrease in vision in the study eye as a consequence of DME
- •Best corrected baseline visual acuity (BCVA) between 24 and 78 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 3 meters.
- •Study eye Central retinal thickness (CRT) at least 300µm on OCT ( Heidelberg Spectralis OCT)
排除标准
- •Pregnant or lactating women and women of reproductive age not using effective contraception.
- •Systemic disease or a condition (controlled or uncontrolled) that, in the opinion of the investigator, might regress, recur or change and consequently have a potential impact (bias) on the assessment of study outcomes.
- •Stroke or myocardial infarction less than 3 months prior to screening for eligibility.
- •Uncontrolled blood pressure (defined as a systolic of >160mmHg or diastolic >100mmHg) at screening
- •Uncontrolled diabetes, defined by HBA1c>12%
- •Patients with known sensitivity to Aflibercept preparations
- •Patients taking or planning to take any systemic medications known to be toxic to the lens or retina or optic nerve.
- •Any active ocular or peri-ocular infection or inflammation
- •Active proliferative diabetic retinopathy in study eye.
- •Visually significant cataract
- •Any other macular pathology in the study eye that may influence the outcomes of the study (e.g. laser burns or scars, wet Age-related macular degeneration, macular holes.)
- •Uncontrolled glaucoma
- •Any previous treatment with anti-angiogenic drugs in the study eye within 120 days of commencing the study.
- •Any previous treatment with anti-angiogenic drugs in the fellow eye within 90 days of commencing the study.
- •More than two previous macular laser photocoagulation treatments in the study eye in the past 6 months.
- •Pan-retinal or macular laser photocoagulation in study eye within the 90 days of commencing the study.
- •Treatment of study eye with intraocular /peri ocular corticosteroids within 120 days of commencing the study.
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