Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab (2.0mg) Prospectively
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss
研究概览
简要总结
Monthly, continuous anti-vegf therapy for patients presenting with active polypoidal choroidal vasculopathy. Two arms, treatment naive and previously treated with an FDA approved anti-VEGF therapy, will be randomized and dosed with open label 2.0mg ranibizumab.
详细描述
Patients will be followed with spectral oct, 4m BCVA, ICG, FA and monthly eye examinations for one year.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study
- •Age >= 25 years
- •Polypoidal choroidal vasculopathy as noted on fluorescein and ICG angiography: active leakage, active bleeding or recent decrease in vision
- •BVCA using ETDRS of 20/32 to 20/400
排除标准
- •Any history of prior vitrectomy
- •Any prior treatment with verteporfin PDT in the study eye
- •Previous cataract surgery within the preceding 2 months of D0
- •Active intraocular inflammation in the study eye
- •Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- •A condition, that in the opinion of the investigator, would preclude participation in the study (e.g. unstable medical status including blood pressure, cardiovascular disease)
- •Participation in another investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.
- •Prior anti-VEGF (Macugen, Avastin, Lucentis) in the study eye within 30 days prior to enrollment in this study
- •Known allergy to any component in the study drug
- •Uncontrolled hypertension: >180/110
- •major surgery within 28 days prior to randomization
- •Myocardial infarction, other cardia events requiring hospitalization within 6 months prior to randomization
- •Systemic anti-VEGF or pro-VEGF within 3 months of randomization
- •Pregnancy or lactation
- •History of recurrent significant infections or bacterial infections
研究组 & 干预措施
Previously Treated
With prior anti-vegf therapy, only, no sooner than 30 days prior to enrollment into trial
干预措施: ranibizumab 2.0mg (Drug)
Treatment-Naive
Treatment-Naive: no previous treatment for PCV
干预措施: ranibizumab 2.0mg (Drug)
结局指标
主要结局
To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss
时间窗: 1 year
To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss, as measured by calculating the mean change in VA from baseline to Month 12
次要结局
- To evaluate the safety and tolerability of intravitreal injections of 2.0mg ranibizumab administered monthly(1 year)
- To evaluate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab in preventing vision loss(1 year)
- To investigate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab on clinical findings associated with PCV(1 year)