EUCTR2019-001506-17-FR进行中（未招募）1 期
A Phase 2, randomised, multicentre study to assess the dose level of multiple THR-149 injections and to evaluate the efficacy and safety of THR-149 versus aflibercept for the treatment of diabetic macular oedema (DME) - KALAHARI
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Oxurion NV
- 入组人数
- 122
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
- •Written informed consent obtained from the subject prior to screening procedures
- •Male or female aged 18 years or older at the time of signing the informed consent
- •Type 1 or type 2 diabetes
- •BCVA ETDRS letter score = 73 and = 39 in the study eye
- •CI-DME with CST of = 320µm in men or = 305µm in women, on Spectralis SD-OCT in the study eye
- •BCVA ETDRS letter score = 34 in the fellow eye
- •Received = 5 anti-VEGF injections for the treatment of CI-DME
- •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 61
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 61
排除标准
- •Macular oedema due to causes other than DME in the study eye
- •Concurrent disease in the study eye, other than DME, that could require medical or surgical intervention during the study period or could confound interpretation of the results
- •Any condition in the study eye that could confound the ability to detect the efficacy of the IMP
- •Presence of neovascularisation at the disc in the study eye
- •Presence of iris neovascularisation in the study eye
- •previous confounding medications / interventions, or their planned administration
- •Uncontrolled glaucoma in the study eye
- •Any active or suspected ocular or periocular infection, or active intraocular inflammation, in either eye
- •Previously received THR-149 in either eye
- •Untreated diabetes
- •Glycated haemoglobin A (HbA1c) > 12%
- •Uncontrolled hypertension
研究者
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