EUCTR2016-004648-12-PL进行中（未招募）1 期
SAPPHIRE: A RANDOMIZED, MASKED, CONTROLLED TRIAL TO STUDY THE SAFETY AND EFFICACY OF SUPRACHOROIDAL CLS-TA IN CONJUNCTION WITH INTRAVITREAL AFLIBERCEPT IN SUBJECTS WITH RETINAL VEIN OCCLUSION - SAPPHIRE
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
- 460
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
- •Has a clinical diagnosis of RVO in the study eye
- •Has a CST of = 300 µm in the study eye
- •Has an ETDRS BCVA score of = 20 letters read and = 70 letters read in the study eye;
- •Is naïve to local pharmacologic treatment for RVO in the study eye;
- •Is at least 18 years of age
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any active ocular disease or infection in the study eye 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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