ACTRN12613001303730已完成1 期
A Pilot Phase 1/2, Double Blind, Parallel Group, Controlled Study of the Safety, Tolerability and preliminary Efficacy evaluation of intravitreally administered Pfenex ranibizumab (PF582) biosimilar versus Lucentis (registered trademark) for the treatment of neovascular age related macular degeneration (AMD)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfenex Inc.
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 50 Years 至 o limit（—）
- 性别
- All
入选标准
- •Presence in the study eye of previously untreated active
- •neovascularization due to AMD
- •- Visual acuity between 20/25 and 20/320
- •- Neovascularization, fluid, or haemorrhage under the fovea
- •- Fibrosis less than 50% of total lesion area
- •- At least 1 drusen in either eye or late AMD in fellow eye
- •- Female participants must be of non-childbearing potential
排除标准
- •- Previous treatment for AMD in study eye
- •- Other progressive retinal disease in the study eye, or the non-study eye, likely to compromise Visual Acuity assessment.
- •- Contraindications to injections with Lucentis
- •- Previous Lucentis treatment
- •- Any other treatment (photocoagulation, phototherapy, radiotherapy, surgery, thermotherapy) in the last 3 months
- •- Aphaky, vitrectomy
- •- Active or suspected ocular or periocular infection
- •- Active intraocular inflammation
- •- Active systemic infection
- •- History of stroke or congestive heart failure
- •- Any other clinical significant illness or abnormalities that would compromise the safety of the participant
- •- Inability to comply with study or follow up procedures
研究者
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