EUCTR2017-004010-26-FR进行中（未招募）1 期
A Phase 2, open-label, multi-centre study to assess the efficacy and safety of intravitreal THR-317 for the treatment of macular telangiectasia Type 1 (MacTel 1)
ThromboGenics NV0 个研究点目标入组 10 人开始时间: 2018年6月7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
- 10
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
- •- Macular oedema caused by MacTel 1, with Central Subfield Thickness (CST) >300µm on spectral domain optical coherence tomography (SD-OCT)
- •- Written informed consent obtained from the subject prior to study 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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •- Type 1 or type 2 diabetes
- •- Medical history suggesting telangiectasia due to causes other than MacTel 1
- •- Concurrent disease in the study eye that could require medical or surgical intervention during the study period up to 30 days after the last study treatment, or could confound interpretation of the results
- •- Previous treatments / procedures as listed below, or their planned / expected use during the study period for up to 30 days after the last study treatment:
- •* Anti-vascular endothelial growth factor (anti-VEGF) treatment in the study eye (1 month)
- •* Intraocular surgery in the study eye (3 months)
- •* Laser photocoagulation in the study eye (3 months)
- •* Intraocular or periocular corticosteroids in the study eye (4 months)
- •* Ozurdex® (dexamethasone intravitreal implant) in the study eye (6 months)
- •* Other steroid implant in the study eye (any time)
- •- Uncontrolled glaucoma in the study eye
- •- Any active ocular / intraocular infection or inflammation in either eye
- •- Pregnant or lactating female
- •- Female of child-bearing potential not utilising an adequate form of contraception, or planning to become pregnant or to discontinue contraceptive precautions at any time during the entire study period
- •- Male of reproductive potential not utilising contraception
研究者
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