NCT01315275已完成4 期
An Open-label, Multicenter, Phase IV Study of the Efficacy and Safety of Ranibizumab 0.5mg in Diabetic Patients Presenting a Visual Impairment Due to Macular Edema in Current Medical Practice
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 394
- 试验地点
- 1
- 主要终点
- proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
The purpose of this study is to evaluate the proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA) at 6 months in current medical practice.
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 patients >18 years of age who have signed an informed consent
- •Patients with Type 1 or Type 2 diabetes mellitus (according to ADA or WHO guidelines) with HbA1c not more than 10.0% at screening (Visit 1). Patients should be on diet, exercise, and/or pharmacological treatment for diabetes.
- •Patients with visual impairment due to focal or diffuse DME in at least one eye
- •Central Retinal thickness on OCT ≥ 250 microns in the central subfield
- •BCVA score between 78 and 39 letters, inclusively, using ETDRS-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160)
- •Decrease in vision is due to DME and not due to other causes, in the opinion of the investigator
- •Medication for the management of diabetes must have been stable within 3 months prior to randomization and is expected to remain stable during the course of the study.
排除标准
- •Ocular concomitant conditions/ diseases
- •Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment
- •Active intraocular inflammation (grade trace or above) in either eye
- •Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye
- •History of uveitis in either eye Systemic conditions or treatments
- •Active systemic infection
- •History of stroke < 3 months
- •Renal failure requiring dialysis or renal transplant OR renal insufficiency with creatinine levels > 2.0 mg/dl
- •Untreated diabetes mellitus
- •Blood pressure systolic > 160 mmHg and diastolic > 100 mmHg
- •Untreated hypertension
- •Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation Others
- •Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Ranibizumab
Experimental
干预措施: Ranibizumab (Drug)
结局指标
主要结局
proportion of patients with a 10 letters gain on Best Corrected Visual Acuity (BCVA)
时间窗: 6 months
次要结局
- mean average change in BCVA from baseline(6 months)
- mean number of injections needed to obtain a stable visual acuity for three consecutive monthly assessments(6 months)
- if the letters gain after 2 injections is predictive from the letters gain at 6 months(6 months)
- mean number of injections needed to obtain a 10 letters gain(6 months)
- efficacy of ranibizumab IVT on Central Retinal Thickness (OCT)(6 months)
研究者
研究点 (1)
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