EUCTR2017-002089-37-HU进行中（未招募）1 期
TOPAZ: A RANDOMIZED, MASKED, CONTROLLED TRIAL TO STUDY THE SAFETY AND EFFICACY OF SUPRACHOROIDAL CLS-TA IN COMBINATION WITH AN INTRAVITREAL ANTI-VEGF AGENT IN SUBJECTS WITH RETINAL VEIN OCCLUSION - TOPAZ
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 325
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
- •1. Has a clinical diagnosis of RVO in the study eye within = 6 months screening;
- •2. Has a CST of = 300 µm in the study eye as measured by spectral-domain optical coherence tomography (SD-OCT) with intraretinal or subretinal fluid and confirmed by the central reading center (CRC);
- •3. Has an ETDRS BCVA score of = 20 letters read and = 70 letters read in the study eye; at least 20 letters in the non-study eye;
- •4. Is naïve to local pharmacologic treatment for RVO in the study eye;
- •5. Is at least 18 years of age, understands the language of the informed consent and is willing and able to provide written informed consent before any study procedures, and is willing to comply with the instructions and attend all scheduled study visits.
- •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 460
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •* macular edema with etiology other than RVO
- •* intraocular pressure >21mmHg in study eye at visit 1
- •* history of glaucoma, optic nerve head change consistent with glaucoma damage; or ocular hypertension in the study eye requiring more than one medication.
- •* any uncontrolled systemic disease that, in the opinion of the investigator, would preclude participation in the study.
- •* any evidence of neovascularization in the study eye.
研究者
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