NCT01115556已完成1 期
This is a Single-masked Study to Compare Intravitreally Administered 0.5 mg Ranibizumab to 2.0 mg Ranibizumab in Subjects Who Manifest Persistent or Recurrent Macular Fluid Less Than 30 Days Following Treatment With Intravitreal Anti-VEGF Therapy.
Vitreous -Retina- Macula Consultants of New York1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Mean Change in Visual Acuity (VA) From Baseline at Month 6
研究概览
简要总结
This is a single-masked study to compare intravitreally administered 0.5 mg ranibizumab to 2.0 mg ranibizumab in subjects who manifest persistent or recurrent macular fluid less than 30 days following treatment with intravitreal anti-VEGF therapy. Patients will be masked to their treatment assignment.
The study duration is anticipated to be 12 months and will enroll 30 subjects . Patients will be randomized 2:1 to either 2.0 mg ranibizumab or 0.5mg ranibizumab.
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be eligible if the following criteria are met:
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study
- •Age > 50 years
- •Subfoveal neovascularization secondary to AMD
- •Best corrected visual acuity in the study eye between 20/30 to 20/400 using an ETDRS chart
- •Documentation of the presence of subretinal fluid and/or cystoid macular edema on SD-OCT less than 30 days following at least six months of anti-VEGF therapy
- •Presence of fibrosis, hemorrhage, or other hypofluorescent lesions should not obscure greater than 50% of the CNV lesion
排除标准
- •Subjects who meet any of the following criteria will be excluded from this study:
- •Pregnancy (positive pregnancy test) or lactation
- •Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- •Participation in another simultaneous medical investigation or trial
- •Prior treatment with anti-VEGF therapy in the study eye within 30 days of BSL
- •Prior treatment with triamcinolone in the study eye within 6 months of BSL.
- •Prior treatment with dexamethasone in the study eye within 30 days prior to BSL
- •Past treatment with PDT or thermal laser in the study eye
- •Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding BSL
- •History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
- •Active intraocular inflammation (grade trace or above) in the study eye
- •Current vitreous hemorrhage in the study eye
- •History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
- •Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- •Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication)
- •History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
- •History of allergy to fluorescein, not amenable to treatment
研究组 & 干预措施
LUCENTIS 0.5 mg
Active Comparator
干预措施: Ranibizumab (Drug)
Lucentis 2.0 mg
Experimental
Lucentis 2.0 mg
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Mean Change in Visual Acuity (VA) From Baseline at Month 6
时间窗: Baseline and 6 months
次要结局
- Mean Change in Visual Acuity (VA) From Baseline at Month 12(one year)
研究者
研究点 (1)
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