EUCTR2010-021777-37-DE进行中（未招募）1 期
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 - Ranibizumab short- and long-term effects on retinal function in wAMD
niversitätsklinikum Schleswig-Holstein (UK-SH)0 个研究点目标入组 20 人开始时间: 2010年8月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.wet age-related macular degeneration (AMD)
- •2.an available follow-up of 12 months
- •3. written informed consent
- •4. visual acuity of 0.1 or better
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.history or evidence of severe cardiac disease (e.g., NYHA functional class III or IV)
- •2.clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months
- •3. ventricular tachyarrythmias requiring ongoing treatment
- •4.History or evidence clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation
- •5.Clinically significant impaired renal or hepatic function
- •6. Stroke within 12 month before trial entry.
- •7.Known serious allergies to the fluorescein dye use in angiography
- •8.Known contraindications to the components of Lucentis® formulation.
- •Ocular concomitant conditions/ diseases
- •1.Active intraocular inflammation (grade trace or above) in either eye
- •2.Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye
- •3. History of uveitis in either eye
- •4.Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate,bevacizumab, etc.) or intravitreal corticosteroids in either eye within 3 months prior to inclusion
- •5.Angle block glaucoma
- •6.Phthisis
- •7.Intraocular Pressure <10mmHg
- •8.Macular or retinal dystrophies
研究者
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A prospective, non-randomized, mono-center, cohort study to evaluate the effects of 0.5mg intraocular Ranibizumab (Lucentis) injections on retinal function in patients with diabetic macular edema (DME) during twelve months - Ranibizumab short- and long-term effects on retinal function in wAMDRetinal function in patients with wet age-related macular degenerationMedDRA version: 14.0Level: LLTClassification code 10067791Term: Wet macular degenerationSystem Organ Class: 10015919 - Eye disordersEUCTR2011-002202-70-DEniversitätsklinikum Schleswig-Holstein (UK-SH)
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