EUCTR2010-021923-29-AT进行中（未招募）1 期
Management of recurrent or persistent choroidal neovascularization secondary to age-related macular degeneration A prospective, randomized, clinical study
niversitätsklinik für Augenheilkunden und Optometrie, Medizinische Universität Wien0 个研究点目标入组 60 人开始时间: 2011年7月12日最近更新:
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
- 60
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 50 years of age or older.
- •Patients with persistent or recurrence subfoveal CNV lesion secondary to AMD
- •Patients who have a BCVA score better than 20/400 in the study eye using ETDRS.
- •At least 6 initial intravitreal ranibizumab monotherapy
- •The initial intravitreal ranibizumab treatment performed within the last 6 – 12 months.
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Any prior initial intravitreal treatment other than intravitreal ranibizumab.
- •History of glaucoma filtration surgery, corneal transplant surgery or extracapsular extraction of cataract with
- •phacoemulsification within six months preceding Visit 1, or a history of post-operative complications within the
- •last 12 months preceding Visit 1 in the study eye (uveitis, cyclitis etc.).
- •History of uncontrolled glaucoma in the study eye (defined as intraocular pressure = 25 mmHg despite
- •treatment with anti-glaucoma mediation).
- •Aphakia or absence of the posterior capsule in the study eye.
- •Presence of a retinal pigment epithelial tear involving the macula in the study eye.
- •Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion
- •of the investigator, could either require medical or surgical intervention during the three-month study period to
- •prevent or treat visual loss that might result from that condition.
- •Active intraocular inflammation (grade trace or above) in the study eye.
- •Any active infection involving eyeball adnexa.
- •Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the
- •Other ocular conditions that require chronic concomitant therapy with systemic or topical ocular corticosteroids.
- •Chronic concomitant therapy is defined as multiple doses taken daily for three or more consecutive days at any
- •time within six months prior to screening or during the course of the study.
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