EUCTR2009-014612-34-PT进行中（未招募）1 期
Prospective, multicenter, open-label study to evaluate the safety and efficacy of intravitreal ranibizumab in patients with subfoveal or juxtafoveal choroidal neovascularization (CNV) secondary to other causes than Age-related Macular Degeneration and Pathological Myopia (angioid streaks, pseudohistoplasmosis, inflammatory chorioretinal diseases and idiopathic lesions).
AIBILI - Association for Innovation and Biomedical Research on Light and Image0 个研究点目标入组 20 人开始时间: 2011年4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
- 入组人数
- 20
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
- •1.Male or female patients 18 years old or greater.
- •2.Diagnosis of active primary or recurrent choroidal neovascularization (CNV) secondary to other causes than Age-related Macular Degeneration or Pathological Myopia. Patients previously receiving CNV therapy with verteporfin photodynamic therapy and/or intravitreal steroids in the study eye will be eligible to participate in the study if continued treatment is needed for their CNV due to FA leakage and/or re-accumulation of retinal fluid (e.g. re-accumulation of sub retinal intra retinal or sub-pigment epithelium fluid at least 1 month after last treatment will be considered eligible).
- •3.The total lesion area must be = 12 disc areas.
- •4.Best-corrected Visual Acuity > 20/400 (20 letters in the ETDRS Chart) in the study eye.
- •5.Expectation by the investigator that patient will potentially benefit from ranibizumab treatment.
- •6.Willing and able to give written informed consent according to legal requirements, and who have signed the consent form prior to initiation of any study procedure.
- •7.Willing and able to comply with all study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Previous intravitreal treatment in the study eye with bevacizumab, ranibizumab or pegaptanib.
- •2.Laser photocoagulation, treatment with intravitreal steroids or verteporfin photodynamic therapy (Visudyne®) in the study eye 3 months preceding Day 1.
- •3.Prior treatment in the study eye with external-beam radiation therapy, vitrectomy, or transpupillary thermotherapy.
- •4.History of surgical intervention in the study eye within 6 months preceding Day 1.
- •5.Previous participation in any studies of investigational drugs 3 months preceding Day 1(excluding vitamins and minerals).
- •6.Ocular disorders in the study eye that may confound interpretation of study results, including exudative age-related macular degeneration, pathological myopia, retinal detachment, vitreous hemorrhage or macular hole or persistent macular edema due to uveitis or other inflammatory diseases.
- •7.Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the 12-month study period.
- •8.Known serious allergies to fluorescein used in angiography, or to components of Lucentis® formulation.
- •9.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive laboratory test (> 5mIU/mL).
- •10.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant UNLESS they are: women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner; women whose partners have been sterilized by vasectomy or other means using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices - IUDs). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not acceptable.
- •Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation.
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