NCT01908816已完成3 期
An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare VEGF driven ocular diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active choroidal neovascularization (CNV)
- •Active macular edema (ME)
- •Rubeosis iridis/neovascular glaucoma.
- •Proliferative diabetic retinopathy requiring vitrectomy.
排除标准
- •wet Age-related macular degeneration
- •pathologic myopia
- •pseudoxanthoma elasticum
- •diabetic macular edema
- •retinal vein occlusion
- •< 18 years of age
- •History of hypersensitivity to ranibizumab
- •Use of any systemic anti-angiogenic drugs 3 months before inclusion
- •Women of child-bearing potential and Pregnant or nursing (lactating) women.
- •Active or suspected ocular infection
研究组 & 干预措施
ranibizumab
Experimental
0.5 mg ranibizumab applied in an individualized regimen as IVT injection of 0.05 mL.
干预措施: ranibizumab (Drug)
结局指标
主要结局
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
时间窗: 24 months
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) for ocular and non-ocular events. Due to early termination, only descriptive analysis was conducted.
次要结局
- Change From Baseline Best Corrected Visual Acuity (BCVA) for Patients With Choroidal Neovascularization (CNV) and Macular Edema (ME)(3 months, 12 months)
- Average Change of Neovascularization Extension for Patients With Neovascular Glaucoma(3 month, 12 month)
- Proportion of Patient With Vitreous Cavity Hemorrhage Occurrence for Patient With Proliferative Retinopathy(3 months, 12 month)
- Mean Change From Baseline in Change in Central Retinal Thickness for Patients With CNV (Choroidal Neovascularization) and ME (Macular Edema)"(3 months, 12 month)
- Proportion of Patients With Angiographic Leakage(3 months, 12 month)
- Ranibizumab Injection(3 months, 12 month)
研究者
研究点 (1)
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