Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial
This research is being done to look at the effects of an experimental drug, ranibizumab, on a condition called "predominantly hemorrhagic subfoveal choroidal neovascularization (CNV)" due to wet age-related macular degeneration.
A predominantly hemorrhagic CNV lesion is diagnosed when at least 50% of the choroidal neovascular lesion is occupied by blood under the retina. We want to find out if injections of ranibizumab into the eye will help patients with this condition.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
Maryland
-
Baltimore、Maryland、美国、21287
- The Wilmer Eye Institute at Johns Hopkins
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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.
- Predominantly hemorrhagic subfoveal CNV (at least 50% of the lesion composed of hemorrhage) from age-related macular degeneration (AMD) resulting in visual acuity of 20/40 or worse.
- Age greater than 50 years.
- Participant must have media clear enough to permit fundus photography, fluorescein angiography, and optical coherence tomography.
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from this study:
- Known hypersensitivity to humanized monoclonal antibodies
- History (within past 6 months) or evidence of severe cardiac disease (apparent in electrocardiogram abnormalities, clinical history of unstable angina, acute coronary syndrome, myocardial infarction, revascularization procedure within 6 months prior to baseline, atrial or ventricular tachyarrhythmias requiring ongoing treatment).
- History of stroke within 6 months of study entry.
- Current acute ocular or periocular infection.
- Any major surgical procedure within one month of study entry.
- Known serious allergies to fluorescein dye.
- Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, Protein Kinase C inhibitors, etc) within last 6 months.
- Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye within the last 6 months.
- History of subfoveal laser treatment in the study eye.
- History of other visually-limiting conditions such as optic neuropathy, amblyopia, choroidal neovascularization due to causes other than AMD in the study eye.
- Ocular inflammation (including trace or above) in the study eye.
- Inability to comply with study or follow up procedures.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：A
0.3 mg/0.05 ml dose of ranibizumab
|
0.3 毫克/0.05 毫升剂量
其他名称：
0.5 毫克/0.05 毫升剂量
其他名称：
|
|
实验性的：B
0.5 mg/0.05 ml dose of ranibizumab
|
0.3 毫克/0.05 毫升剂量
其他名称：
0.5 毫克/0.05 毫升剂量
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Subjects Avoiding 15 or More Letter Loss of Best Corrected Visual Acuity From Baseline to 12 Months on an Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Chart Measured at 4 Meters.
大体时间：12 months
|
Visual acuity measured prior to first treatment with ranibizumab and at 12 months following the first treatment were compared for each subject enrolled in the study.
The 12 month follow-up visual acuity was subtracted from the baseline visual acuity.
Avoiding a 15 or more letter loss in visual acuity was considered a successful outcome.
|
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Retinal Changes on Funduscopy
大体时间：12 months
|
12 months
|
|
|
Retinal Thickness Measured by Optical Coherence Tomography (OCT)
大体时间：12 months
|
12 months
|
|
|
Fluorescein Leakage on Fluorescein Angiography
大体时间：12 months
|
12 months
|
|
|
Number of Subjects Experiencing Complications Related to Drug or Its Administration
大体时间：12 months after last injection
|
Potential complications included:
Subjects were monitored for potential drug-related ocular adverse effects: intraocular inflammation (uveitis), endophthalmitis, central retinal vein occlusion, transient elevation of IOP, acute reduction in the visual acuity, vitreous hemorrhage, injection-site pain, retinal hemorrhage, posterior vitreous detachment, and subconjunctival hemorrhage. Subjects were monitored for potential adverse effects of intravitreal injections: crystalline lens penetration, retinal break and/or detachment, vitreous hemorrhage, inflammation, and infection. Potential systemic adverse effects were captured by monitoring vital functions such as cardiovascular function, nervous system function, renal function, and gastrointestinal function. |
12 months after last injection
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
雷珠单抗的临床试验
-
Hoffmann-La Roche完全的
-
Hoffmann-La Roche招聘中新生血管性年龄相关性黄斑变性比利时, 美国, 英国, 意大利, 阿根廷, 西班牙, 以色列, 澳大利亚, 奥地利, 巴西, 德国, 瑞士, 台湾, 法国
-
Hoffmann-La Roche招聘中新生血管性年龄相关性黄斑变性 (nAMD)比利时, 大韩民国, 德国, 西班牙, 英国, 澳大利亚, 意大利, 阿根廷, 以色列, 奥地利, 巴西, 法国, 新加坡, 瑞士, 台湾, 火鸡