Treatment of Polypoidal Choroidal Vasculopathy With Ranibizumab(Lucentis): A Phase I/II Safety Study.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Commonly Reported and Notable Adverse Events
研究概览
简要总结
This Phase I/II safety study is designed to investigate the safety and efficacy of ranibizumab (Lucentis) in the treatment of polypoidal choroidal vasculopathy (PCV), a potentially blinding eye disease that involves the growth of tiny, abnormal blood vessels under the retina. These abnormal blood vessels can bleed or leak fluid, causing disruption of normal retinal function and vision loss. Ranibizumab is a drug that is FDA-approved for the treatment of wet age-related macular degeneration (AMD) and is injected directly into the eye. Given the efficacy of ranibizumab in the treatment of wet AMD, and the postulated similarity between the disease mechanisms involved in both wet AMD and PCV, we believe ranibizumab will have a beneficial effect on visual function in patients with PCV.
详细描述
Please see above description. Phase I/II safety study; prospective, open-label, single-center, non-randomized, uncontrolled, consecutive interventional case series. Enrolled patients are >35 years old and display exudative, active polypoidal choroidal vasculopathy (PCV) in 1 eye. PCV is defined as choroidal neovascularization that displays occult characteristics on fluorescein angiography and polypoidal interconnecting vascular channels with saccular dilatations on indocyanine green angiography and/or fluorescein angiography. Eyes receive 3 consecutive, monthly intravitreal ranibizumab injections (0.5 mg or 0.3 mg/0.05 cc) followed by monthly evaluations with the option of additional intravitreal ranibizumab or alternative treatments at the discretion of the investigator. Baseline and follow-up evaluations include medical history, blood pressure, physical examination, early treatment diabetic rentinopathy study (ETDRS) best-corrected visual acuity (BCVA), intraocular pressure measurement, complete ophthalmologic examination, fundus photography, fluorescein/ indocyanine green (ICG) angiography, and optical coherence tomography (OCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >35 years
- •Exudative, active PCV in 1 eye.
- •PCV is defined as choroidal neovascularization that displays occult characteristics on fluorescein angiography and polypoidal interconnecting vascular channels with saccular dilatations on indocyanine green angiography and/or fluorescein angiography.
排除标准
- •Age <35 years
- •Prior treatment with non-ranibizumab therapies (e.g., laser, surgery, or bevacizumab)
研究组 & 干预措施
Ranibizumab 0.5 mg/ 0.05 cc
Intraocular injection of 0.5 mg/ 0.05 cc ranibizumab
干预措施: ranibizumab 0.5 or 0.3 mg/0.05 cc (Drug)
Ranibizumab 0.3 mg/ 0.05 cc
Intraocular injection of 0.3 mg/ 0.05 cc ranibizumab
干预措施: ranibizumab 0.5 or 0.3 mg/0.05 cc (Drug)
结局指标
主要结局
Commonly Reported and Notable Adverse Events
时间窗: 2 years
Incidence and severity of ocular adverse events, as identified by indirect and direct examination. Examples include 30 letter loss, major subretinal hemorrhage, involving 75% or more of clinical macula (arcade to arcade), disease-related vitreous hemorrhage, injection-related endopthalmitis, retinal detachment, vitreous hemorrhage, study drug/procedure related uveitis, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs.
次要结局
未报告次要终点
研究者
Dennis M. Marcus, M.D.
Dr. Dennis M. Marcus Principal Investigator
Southeast Retina Center, Georgia