EUCTR2009-017782-30-AT进行中(未招募)1 期
Treatment of macular edema due to central retinal vein occlusion with ranibizumab (Lucentis®). - Lucentis in CRVO
Medizinische Universität Graz, Universitäts-Augenklinik0 个研究点开始时间: 2010年2月19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
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
- •Patients who at baseline
- •1. have a best corrected visual acuity (BCVA) in the study eye between 20/40 to 20/400 (EDTRS charts, visual acuity measured at 4 meters).
- •2. have clinical, angiographical and optical coherence tomography (OCT) evidence (central retinal thickness >250µm) of macular edema due to CRVO.
- •3. are willing and able to provide written informed consent.
- •4. are willing to return for the scheduled visits for a 12 month period.
- •5. Only one eye will be assessed in the study. If both eyes are eligible, the one with worse visual acuity will be selected for treatment and study unless, based on medical reasons, the investigators deem the other eye the more appropriate candidate for treatment and study.
- •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
- •Patients who at baseline
- •1. are younger than 19 years of age.
- •2. are mentally disabled.
- •3. are participating in another clinical study.
- •4 show a decrease in visual acuity due to causes other than CRVO e.g. history of exudative age-related macular degeneration, diabetic macular edema, choroidal neovascularizations of any cause.
- •5. had prior intravitreal anti-VEGF or intravitreal/periocular corticosteroid treatment of CRVO.
- •6. have concomitant use of corticosteroids (by any route) for the duration of study participation (chronic use is defined as multiple doses taken daily for three or more consecutive days at any time during the study).
- •7. have a history of radial optic neurotomy.
- •8. have a history of vitreo-retinal surgery in the study eye or anticipated surgery within the next 12 months.
- •9. have a history of uncontrolled glaucoma in the study eye (defined as intraocular pressure = 25 mmHg despite treatment with topical anti-glaucomatous medication).
- •10. show presence of vitreoretinal traction or epiretinal gliosis affecting central vision.
- •11. had any intraocular surgery (cataract surgery or Yag Capsulotomy) within 3 months prior to enrolment.
- •12. present with neovascular glaucoma, iris neovascularization, vitreous hemorrhage in the study eye.
- •13. have aphakia or absence of the posterior capsule in the study eye.
- •14. show uncontrolled arterial hypertension and/or diabetes mellitus.
- •15. have a history of myocardial infarction or stroke within 6 months prior to enrolment.
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