EUCTR2016-002100-25-HU进行中（未招募）1 期
A Phase 2, single-masked, multicentre study to evaluate the safety and efficacy of 2 dose levels of THR-317 for the treatment of diabetic macular oedema (DME)
ThromboGenics NV0 个研究点目标入组 50 人开始时间: 2016年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female aged 18 years or older
- •Type 1 or type 2 diabetes
- •Centre-involved DME with central subfield thickness (CST) = 340µm on Spectralis spectral domain optical coherence tomography (SD-OCT) or = 320µm on non-Spectralis SD-OCT, in the study eye
- •Reduced vision primarily due to DME, with BCVA between 72 and 23 ETDRS letters read (20/40 and 20/320 Snellen equivalent) in the study eye
- •Anti-VEGF treatment naïve study eye or poor response to prior anti-VEGF treatment in the study eye
- •Non-proliferative diabetic retinopathy (NPDR) or stable proliferative diabetic retinopathy (PDR) without neovacularisation at the disc (NVD)
- •Written informed consent obtained from the subject prior to screening procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Concurrent disease in the study eye, other than DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results
- •Previous treatments / procedures as listed below or their planned use during the THR-317 treatment period for up to 30 days after the last injection
- •Treatment / Procedure in Excluded Period prior to
- •the Study Eye Visit 2 (Day 0)
- •Panretinal or focal / grid laser 3 months
- •photocoagulation
- •Anti-VEGF treatment Any time for anti-VEGF naïve
- •subjects; 4 weeks for subjects
- •with a poor response to anti-VEGF
- •Intra-ocular or peri-ocular 4 months
- •corticosteroids
- •Steroid implant Any time
- •Intra-ocular surgery 3 months
- •Vitrectomy Any time
- •Any active ocular / intra-ocular infection or inflammation in either eye
- •Aphakic study eye
- •Untreated diabetes
- •Glycated haemoglobin A (HbA1c) > 12%
- •Uncontrolled hypertension in the opinion of the Investigator
- •Pregnant or lactating female or female of child-bearing potential not utilising an adequate form of contraception or male of reproductive potential not utilising contraception
研究者
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