NCT01710332已完成2 期
Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study
Wills Eye2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Safety of Intravitreal Aflibercept Injection
研究概览
简要总结
A preliminary study to determine the safety and efficacy of intravitreal aflibercept injection in patients with persistent central serous chorioretinopathy.
详细描述
Intravitreal Aflibercept Injection for Persistent Central Serous Chorioretinopathy: A Prospective Pilot Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-treatment acuity of 20/40- 20/320
- •Macular fluid on optical coherence tomography for greater than 3 months
- •Leakage on fluorescein angiography
- •Willing and able to comply with clinic visits and study-related procedures
- •Provide signed informed consent
排除标准
- •Treatment for CSCR in the study eye (anti-VEGF, PDT, or laser) within three months prior to study enrollment
- •Presence of choroidal neovascularization on enrollment imaging
- •Prior vitrectomy in the study eye
- •Presence of any substantial ocular disease (other than CSCR) that may compromise vision in the study eye and /or confound interpretation of the data; e.g. substantial cataracts, advanced glaucoma, optic neuritis, optic neuropathy or atrophy, marked macular atrophy, ocular vascular occlusion, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc.
- •History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
- •Uncontrolled glaucoma in the study eye (defined as IOP ≥ 25 mmHg despite treatment with anti-glaucoma medication)
- •Active ocular infection or inflammation in the study eye
- •Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- •Prior treatment with systemic anti-VEGF agents
- •Cerebrovascular accident or myocardial infarction within the preceding 6 months.
- •History of allergy to fluorescein, povidone iodine (Betadine) or aflibercept
- •Participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study
- •Pregnant or breast-feeding women Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
- •Contraception is not required for men with documented vasectomy.
- •Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
研究组 & 干预措施
Intravitreal Aflibercept Injection (x4)
Experimental
2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).
干预措施: Intravitreal Aflibercept Injection (Drug)
Intravitreal Aflibercept Injection (x6)
Experimental
2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).
干预措施: Intravitreal Aflibercept Injection (Drug)
结局指标
主要结局
Safety of Intravitreal Aflibercept Injection
时间窗: 6 months
Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.
次要结局
- Change in Vision Based on Letter Score(6 months)
研究者
Allen C. Ho, MD
Investigator
Wills Eye
研究点 (2)
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