EUCTR2014-000975-21-ES进行中（未招募）1 期
A phase IV study to evaluate the effectiveness of aflibercept in naive patients with macular edema secondary to Central Retinal Vein Occlusion (CRVO) on an individualized Treat and Extend regimen. NEUTON study. - NEUTO
Fundación Retinaplus +0 个研究点开始时间: 2014年6月9日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •- Patient ? 50 years old
- •- Patient with newly diagnosis macular edema secondary to central retinal vein occlusion (CRVO) for no longer than 6 months with mean central subfield thickness ? 250 ?m on OCT.
- •- An ETDRS BCVA of 20/40 to 20/320 (73 to 24 letters) in the study eye.
- •- BCVA >20/400 in the fellow eye.
- •- Absence of significant cataract that could affect visual results.
- •- Able to return for ALL clinic visits and complete all study-related procedures.
- •- Absence of other ocular diseases that could affect visual acuity.
- •- Willingness to provide written informed consent.
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •- Previous anti-VEGF therapy, photodynamic therapy or thermal laser in the study eye.
- •- Recent cataract surgery (<3 months) in the study eye.
- •- Any concurrent ocular disease that could affect the final outcome (diabetic retinopathy, advanced glaucoma, pathologic myopia).
- •- No scar, fibrosis, atrophy or hemorrage involving the center of the fovea
- •- No RPE rip/tear involving the central fovea
- •- Severe proliferative macular ischemia patients and iris rubeosis patients
- •- Participation in any other interventional clinical trial
- •- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
- •- Active intraocular inflammation in the study eye
- •- History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
- •?Unable to undergo fluorescein angiography or fundus photography because of uncontrolled allergies
研究者
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