EUCTR2020-000362-42-DE进行中（未招募）1 期
A Phase 2, randomised, multicentre study to assess the dose level of multiple THR-687 injections and to evaluate the efficacy and safety of THR-687 versus aflibercept for the treatment of diabetic macular oedema (DME) - INTEGRA
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
- 303
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 = 78 (Part A) or = 73 (Part B) and = 39 (both study parts) in the study eye
- •- CI-DME with CST = 300µm in men, or = 285µm in women, measured from the retinal pigment epithelium (RPE) to the internal limiting membrane (ILM) inclusively, on SD-OCT, in the study eye
- •- BCVA ETDRS letter score = 34 in the fellow eye
- •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 151
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 152
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 IMPs
- •- ETDRS severity level = 61 (Part A), or ETDRS severity level =65 (Part B), on colour fundus photograph, in the study eye
- •- Presence of iris neovascularisation in the study eye
- •- Previous confounding medications / interventions, or their planned administration during the study
- •- Uncontrolled glaucoma in the study eye
- •- Previously received THR-687 or any other experimental therapy for DME, in either eye
- •- Any active or suspected ocular or periocular infection, or active intraocular inflammation, in either eye
- •- Untreated diabetes
- •- Glycated haemoglobin A (HbA1c) > 12%
- •- Uncontrolled hypertension
研究者
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