EUCTR2020-000681-42-AT进行中（未招募）1 期
ong-term need of ranibizumab injections with or without early targeted peripheral laser photocoagulation for treatment of macular edema due to central retinal vein occlusion - Combination of Ranibizumab and targeted Laser
Justus-Liebig University Gießen0 个研究点目标入组 110 人开始时间: 2022年12月22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
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.Diagnosis of macular edema due to central retinal vein occlusion foveal thickness >250 µm (measured by optical coherence tomography (OCT))
- •2.Age ? 18 years
- •3.Written informed consent of the patient
- •4.Best corrected visual acuity (BCVA) score in the study eye between 24 letters (20/320) and 78 letters (20/25) measured in ETDRS chart
- •5.History of central retinal vein occlusion (CRVO) no longer than 6 months
- •6.Presence of capillary non-perfusion in peripheral retina larger than 5 disc areas documented in ultra wide-field fluorescein angiography
- •7.Ability and willingness to attend all scheduled visits and assessments
- •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. CRVO with ischemic maculopathy defined as diameter of the foveolar avascular zone larger than 2 optic disc diameters
- •2.Macular edema due to another etiology than retinal vein occlusion (e.g. diabetic maculopathy, uveitis, age related macular degeneration, Irvine-Gass syndrome)
- •3.History of idiopathic central serous chorioretinopathy
- •4.Presence of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or in OCT
- •5.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
- •6.Aphakia in the study eye
- •7.Scatter laser photocoagulation or macular photocoagulation in the study eye prior to study entry
- •8.Intraocular or periocular injection of steroids in the study eye prior to study entry
- •9.Previous use of an anti-VEGF drug in the study eye
- •10.Cataract surgery or any other intraocular surgery in the study eye within 3 months prior to study entry
- •11.Uncontrolled glaucoma (defined as intraocular pressure = 30 mmHg despite treatment with maximal anti-glaucoma medications)
- •12.History of stroke, myocardial infarction, transient ischemic attacks within 3 months prior to the study
- •13.Pregnancy (positive urine pregnancy test) or lactation
- •14.The presence of active malignancy, including lymphoproliferative disorders.
- •15. History of allergy to fluorescein or a component of the ranibizumab formulation
- •16.Active intraocular infection
- •17.Participation in another simultaneous interventional medical investigation or trial
- •18.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.
研究者
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