NCT01269151已完成不适用
A Prospective, Non-randomized, Mono-center, Cohort Study to Evaluate the Short- and Long-term Effects of 0.5mg Intraocular Ranibizumab (Lucentis) Injections on Retinal Function in Patients With Wet Age-related Macular Degeneration During Twelve Month
University of Luebeck1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months.
研究概览
简要总结
Multifocal-electroretinoram (ERG) and microperimetry are objective criteria to asses retinal function. No information besides visual acuity exist for the development of retinal function during the course of wet AMD during therapy with Lucentis. The aim of our study is to evaluate the value of multifocal-ERG and microperimetry as an sensitive tool and early predictor of recurrence of the disease. The second goal will be to evaluate the neuroprotective effects of an adequate therapy on retinal function using microperimetry and multifocal-ERG during the course of wet AMD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients above 50 years of age
- •wet age-related macular degeneration (AMD)
- •an available follow-up of 12 months
- •written informed consent
- •visual acuity of 0.1 or better
排除标准
- •Systemic conditions or treatments
- •history or evidence of severe cardiac disease (e.g., NYHA functional class III or IV)
- •clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within the last 6 months
- •ventricular tachyarrythmias requiring ongoing treatment
- •History or evidence clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation
- •Clinically significant impaired renal or hepatic function
- •Stroke within 12 month before trial entry.
- •Known serious allergies to the fluorescein dye use in angiography
- •Known contraindications to the components of Lucentis® formulation.
- •Ocular concomitant conditions/ diseases
- •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
- •Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate,bevacizumab, etc.) or intravitreal corticosteroids in either eye within 3 months prior to inclusion
- •Angle block glaucoma
- •Intraocular Pressure <10mmHg
- •Macular or retinal dystrophies
- •Compliance/ Administrative
- •Previous participation in any clinical studies of investigational drugs (excluding vitamins and minerals) within 1 month (or a period corresponding to 5 half-lives of the investigational drug, whatever is longer) prior to inclusion.
- •Patients will be excluded who were younger than 50 years according of the definition of age-related AMD.
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
- •Pregnant or nursing (lactating) women
- •Inability to comply with study or follow-up procedures.
- •Any treatment with an investigational agent in the past 3 months any condition.
研究组 & 干预措施
Lucentis (Ranibizumab)
Experimental
干预措施: Lucentis (Ranibizumab) (Drug)
结局指标
主要结局
Changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months.
时间窗: 12 months
Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG and microperimetry as measured 12 months.
次要结局
- to document changes in best corrected visual acuity (BCVA) measured on 4 meters,(12 months)
- to document changes in angiography(12 months)
- to document changes in optical coherence tomography (OCT)(12 months)
研究者
Dr. Matthias Lueke
Dr. med. Matthias Lüke
University of Luebeck
研究点 (1)
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