DRKS00000711已完成2 期
Ranibizumab combined with selective peripheral laser photocoagulation for treatment of central retinal vein occlusion - CoRaLa-Study
Klinik und Poliklinik für AugenheilkundeUniversität Leipzig0 个研究点目标入组 22 人开始时间: 2011年2月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
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
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1.Diagnosis of macular edema due to central retinal vein occlusion foveal thickness = 250 µm (measured by OCT)
- •2.Age = 18 years
- •3.Written informed consent of the patient
- •4.BCVA score in the study eye between 24 letters (20/320) and 73 letters (20/40) measured in ETDRS chart
- •5.The history of CRVO no longer than 8 months
- •6.Presence of capillary non-perfusion in peripheral retina larger than 1 and smaller than 10 disc areas documented in fluorescein angiography
- •7.Ability and willingness to attend all scheduled visits and assessments
排除标准
- •1.Ischemic CRVO defined as presence of capillary non-perfusion larger than 10 optic disc areas in fluorescein angiography
- •2.Macular edema due to another etiology than retinal vein occlusion (e.g. diabetic maculopathy, uveitis, age related macular degeneration, Irvine-Gass syndrome)
- •3. Diagnosis of CRVO in both eyes with macular edema requiring any kind of treatment
- •4.History of rhegmatogenous retinal detachment
- •5.History of idiopathic central serous chorioretinopathy
- •6.Presence of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or in OCT
- •7.An eye that, in the investigator's opinion, would not benefit from resolution of macular edema, such as eyes with foveal atrophy, dense pigmentary changes, or dense subfoveal hard exudates
- •8. Patients in which at time of screening the anti-VEGF treatment is planned for the fellow eye for any reason
- •10.Improvement of > 10 letters on BCVA between screening and Day 1
- •11.Scatter laser photocoagulation or macular photocoagulation in the study eye prior to study entry
- •12.Use of intraocular or periocular injection of steroids in the study eye prior to study entry
- •13.Previous use of an anti-VEGF drug in the study eye
- •14.Cataract surgery or Yttrium-Aluminum-Garnet (YAG) laser capsulotomy or any other intraocular surgery in the study eye within 3 months prior to study entry
- •15.History or presence of AMD (dry or wet form)
- •16.Uncontrolled glaucoma (defined as intraocular pressure = 30 mm Hg despite treatment with anti-glaucoma medications)
- •17.Uncontrolled blood pressure defined as pressure = 160/90 mmHg in at least 3 consecutive measurements
- •18.History of cerebral vascular accident
- •19.Pregnancy (positive pregnancy test) or lactation
- •20.The presence of active malignancy, including lymphoproliferative disorders.
- •21.History of allergy to humanized antibodies or any component of the ranibizumab or fluorescein formulation
- •22.Inability to comply with study procedures
- •23.Participation in another simultaneous medical investigation or trial
- •24.Ongoing drug abuse
- •25.HIV positive
- •26.Women with child bearing potency without effective contraception (i. e. implants, injectables, combined oral contraceptives, some IUDs or vasectomised partner) during the conduct of the trial.
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