NL-OMON38832已完成3 期
A 24-month, phase IIIb, randomized, double-masked, multicenter study assessing the efficacy and safety of two treatment regimens of 0.5 mg ranibizumab intravitreal injections guided by functional and/or anatomical criteria, in patients with neovascular age-related macular degeneration (CRFB002A2405, OCTAVE study) - CRFB002A2405 - OCTAVE
ovartis Pharma BV0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Male or female patients at least 50 years of age.
- •Visual impairment predominantly due to neovascular AMD.
- •Active, newly diagnosed, untreated, angiographically documented CNV lesion (see protocol page 22 for details) secondary to AMD.
- •CNV or sequelae of the CNV involving the center of the fovea.
- •The total area of fibrosis comprising less than 50% of the lesion area.
- •BCVA score at Screening and Baseline between 78 and 23 letters (see protocol page 22 for details).
排除标准
- •Pregnant or nursing (lactating) women. Women of child-bearing potential, not practicing adequate contraception.
- •Stroke or myocardial infarction less than 3 months prior to Screening.
- •Systolic BP >160 mm Hg or diastolic BP >100 mm Hg at Screening or Baseline.
- •Any active (peri)ocular infection or inflammation.
- •Uncontrolled glaucoma (intraocular pressure>=30 mm Hg on medication).
- •Neovascularization of the iris or neovascular glaucoma.
- •Exclusion criteria study eye and prior or current medications: see protocol page 24.
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