CTRI/2014/08/004891已完成3 期
A 12-month, randomized, double-masked, sham-controlled,multicenter study to evaluate the efficacy and safety of 0.5mg ranibizumab intravitreal injections in patients withvisual impairment due to vascular endothelial growth factor(VEGF) driven choroidal neovascularization (CNV) - MINERVA
ovartis Healthcare Pvt Ltd0 个研究点目标入组 187 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 187
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
入选标准
- •Diagnosis of treatment naïve (patient has not received any prior medication/ treatment for the CNV lesion under study) active CNV secondary to any causes, except wAMD and PM in adults
- •All types of CNV lesions present in the study eye
- •BCVA must be between >= 24 and <= 83 letters in the study eye tested at 4 meters starting distance using ETDRS like visual acuity charts
- •Visual loss in the study eye should only be due to the presence of any eligible types of CNV based on ocular clinical, as well as FA
排除标准
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment
- •History of malignancy of any organ system within the past 5 years
- •History of stroke less than 6 months prior to screening
- •Active systemic inflammation or infection, related directly to the underlying causal disease of CNV at screening
- •Active diabetic retinopathy, active ocular/periocular infectious disease or active intraocular inflammation at screening
- •Confirmed intraocular pressure >= 25 mmHg for any reason at screening
- •Neovascularization of the iris or neovascular glaucoma at screening
- •CNV secondary to PM or wAMD
- •Use of any systemic anti-VEGF drugs within 6 months before baseline
- •History of focal laser photocoagulation with involvement of the macular area administered to treat CNV at any time
- •History of intraocular treatment with any anti-angiogenic drugs or verteporfin photodynamic therapy at any time
- •History of intravitreal treatment with corticosteroids at any time -History of vitreoretinal surgery at any time.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究者
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