DRKS00005090招募中2 期
Intravitreal Injection of Lucentis (Ranibizumab) after Pars Plana Vitrectomy and Subretinal Application of Recombinant Tissue Plasminogen Activator (rtPA) in Patients with Acute Submacular Hemorrhage as Complication of Exsudative Age-related Macular Degeneration (AMD). - SubMacHem
niversitätsklinikum Schleswig-Holstein Campus Kiel0 个研究点目标入组 15 人开始时间: 2013年12月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 60 Years 至 one（—）
- 性别
- All
入选标准
- •1. Exsudative age-related macular degeneration with acut submacular hemorrhage
- •2. Submacular hemorrhage with involvement of the fovea with a minimum size of 2 papilla-diameters
- •3. Onset of symptoms = 2 weeks
- •4. Age = 60 years
- •5. Written informed consent
排除标准
- •1. Drug addiction or other diseases, which doesn´t allow the person concerned to assess the character and concequences of the clinical trial
- •2. Participation in another clinical trial during or within 4 weeks of study entry.
- •3. Known hypersensitivity to study medication as well as allergy to Fluorescein
- •4. Any severe concomitant condition, which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
- •5. Systemic infection
- •6. History of stroke, transient ischemic attack or myocardial infarction
- •7. History of local or systemic treatment with antiangiogenic drugs (Pegaptanib, Ranibizumab, Bevacizumab, Aflibercept, Anecortave Acetate, Protein Kinase C-Inhibitors)
- •8. The following eye diseases or previous treatments in the study eye:
- •- History of focal macular laser coagulation
- •- History of juxta- or extrafoveal laser coagulation within 1 month of study entry
- •- History of vitrectomy
- •- History of treatment with verteporfin (photodynamic therapy), irradiation or transpupilar thermotherapy due to macular degeneration
- •- Current or suspected ocular or periocular infection
- •- Acute intraocular inflammation
- •- History of retinal detachment
- •- Decompensated glaucoma with an intraocular pressure of = 30 mmHg in spite of medical therapy
- •- History of filtrating glaucoma surgery
- •- History of corneal grafting
- •- Other ocular diseases, which in the opinion of the investigator require surgery within duration of study or lead to a visual loss of 2 lines
- •(ETDRS-chart) within duration of study
- •- Other macular diseases
- •- Diabetic maculopathy
- •- Myopia > -6 diopter
- •- Hyperopia > +6 diopter
- •- Amblyopia
- •- Insufficient quality of fundus imaging due to a poor view into the fundus
- •- Submacular bleeding due to other reasons
- •- Submacular massive bleeding (= bleeding crosses the equator)
- •- Scar in the area of the macula
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