NCT01370135已完成不适用
An Open Label, Prospective, Monocenter, Prove of Concept Study to Evaluate the Short- and Long-term Effects of 0.5mg Intraocular Ranibizumab (Lucentis) Injections as Adjuvant for Patients With Rubeosis and Neovascular Glaucoma
University of Luebeck1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2008年11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
- change of degree of iris rubeosis
研究概览
简要总结
Proliferative ischemic retinopathies lead to a formation of abnormal vessels on the iris surface induced by an increased level of vascular endothelial growth factor (VEGF). In progressive stages fibrovascular membranes occlude the anterior chamber angle which inhibits aqueous outflow resulting in neovascular glaucoma. The increased intraocular pressure is often difficult to control and frequently results in loss of vision.
The aim of this study is to analyze the short- and long-term outcome after adjuvant intraocular Ranibizumab application in patients with neovascular glaucoma and rubeosis and to analyze the role of ranibizumab within a holistic treatment regime.
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
- 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
- •neo-vascular glaucoma or rubeosis
- •definition of neo-vascular glaucoma: patient with iris neovascularization with intraocular pressure elevation (exceeding 21 mmHg)
- •definition of rubeosis: patient with iris neovascularization without intraocular pressure elevation (≤21 mmHg)
- •an available follow-up of 12 months
- •written informed consent
- •visual acuity of light perception or better.
排除标准
- •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 with 6 months
- •ventricular tachyarrhythmias 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, ranibizumab, etc.) or intravitreal corticosteroids in either eye within 4 months prior to inclusion
- •Angle block glaucoma
- •Intraocular Pressure <10mmHg
- •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
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.
- •Pregnant or nursing (lactating) women
- •Inability to comply with study or follow-up procedures.
- •Any treatment with an investigational agent in the past 60 days for any condition.
研究组 & 干预措施
Lucentis (Ranibizumab)
Experimental
干预措施: 0.5mg intraocular Ranibizumab (Lucentis) (Drug)
结局指标
主要结局
change of degree of iris rubeosis
时间窗: 12 Months
Main outcome measure is the change of degree of iris rubeosis as documented by iris fluorescein angiography as measured 12 months after the first ranibizumab injection.
次要结局
- changes in intraocular pressure(12 Months)
- changes in best corrected visual acuity (BCVA)(12 Months)
- numbers of additional interventions(12 Months)
- quality of life(12 Months)
- Number of adverse events in all participants(12 Months)
- changes in gonioscopy(12 Months)
研究者
Dr. Julia Lueke
Dr. med. Julia Lüke
University of Luebeck
研究点 (1)
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