EUCTR2019-003204-12-ES进行中（未招募）1 期
Multicentre, randomised, double-blind, parallel-group, Phase III study to evaluate the genetic polymorphisms influence in the response to Ranibizumab and Bevacizumab treatment in patients with Age-Associated Macular Degeneration. - ICI21/00025
Consorcio PSMAR0 个研究点目标入组 630 人开始时间: 2021年12月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 630
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
- •Patients diagnosed with neovascular Age-related Macular Degeneration and:
- •Age of 50 years or older.
- •That at the discretion of the ophtalmologist has an indication of receiving treatment with an anti VEGF agent as usual in clinical practice.
- •Without previous treatment in the eye under study (no previous treatment for AMD).
- •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 330
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •Participate or have participated in another clinical trial with an experimental drug in the last 6 months.
- •Patients with other eye diseases, p. eg, advanced glaucoma or visually significant cataracts, which are likely to require surgery during the follow-up period in the eye under study.
- •Concomitant, ocular or systemic, administration of drugs up to 3 months before the treatment with another anti-VEGF in the contralateral eye.
- •High cardiovascular risk: poorly controlled arterial hypertension, history or risk of arterial thromboembolic events, history of stroke or acute myocardial infarction, anticoagulant treatment, proteinuria or major elective surgery within 3 months.
- •Ophthalmological risk with the intraocular injection (all intravitreal treatments): active or suspected ocular or periocular infection, severe blepharitis, history of endophthalmitis, history of retinal detachment, myopathy, glaucoma.
- •Hypersensitivity to the active substance or to the excipients.
- •Diabetic retinopathy documented.
- •Pregnant or nursing (lactating) women.
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