A Phase II, Open-label, Multicentre, 12 Month Study to Evaluate the Efficacy and Safety of Ranibizumab (0.5mg) in Patients With Choroidal Neovascularisation Secondary to Pathological Myopia (PM)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- The difference from baseline in mean Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
This study is designed to provide efficacy and safety data in patients with choroidal neovascularisation (CNV) secondary to myopia using an individualized as-needed (PRN) dosing schedule. Eligible patients who have provided written agreement to take part in the study will receive an intravitreal (into the study eye) injection of ranibizumab 0.5mg. Following eye examinations and tests at monthly clinic visits, the study doctor will repeat the injections on a monthly basis as required for an additional 11 months, in accordance with specified retreatment criteria.
Patients will be in the study for approximately 12 months and will visit the hospital clinic 14 times over that period. The main assessments will include visual acuity tests, eye examinations, optical coherence tomography (OCT) to assess retinal thickness, fundus photography and fluorescein angiography (FA), measurement of intraocular pressure, blood pressure and pulse measurements and completion of health-related questionnaires'.
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
- •Male or female outpatients of any race, aged 18 years or older
- •Diagnosis of active primary or recurrent subfoveal or juxtafoveal CNV secondary to PM
- •Diagnosis of high myopia of at least -6 dioptres in the study eye spherical equivalent. For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye must have been at least -6 dioptres
- •Patients who have a BCVA score between 78 and 24 letters in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS)-like grading charts (approximately 6/9 - 6/96 Snellen equivalent)
- •Patients must give fully informed consent and be willing and able to comply with all study procedures
排除标准
- •History of any surgical intervention in the study eye within two months preceding screening
- •Previous macular laser photocoagulation, treatment with intravitreal steroids, verteporfin with photodynamic therapy (Visudyne®) or anti-VEGF agents ranibizumab, bevacizumab or pegaptanib sodium (Macugen®) in the study eye
- •Previous treatment with intravenously administered bevacizumab (Avastin®)
- •Prior treatment in the study eye with external-beam radiation therapy, vitrectomy, or transpupillary thermotherapy
- •History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
- •History of allergic reaction to fluorescein
- •Concurrent use of systemic anti-VEGF agents
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
ranibizumab 0.5mg
干预措施: ranibizumab 0.5mg (Drug)
结局指标
主要结局
The difference from baseline in mean Best Corrected Visual Acuity (BCVA)
时间窗: 12 months
次要结局
- Mean change in BCVA from baseline(6 months)
- Mean change in Central retinal Thickness (CRT) from baseline(6 and 12 months)
- Percentage of patients gaining ≥ 15 letters(12 months)
- Change in lesion size and morphology from baseline(6 and 12 months)
- Time to the first retreatment and the total number of treatments(12 Months)