Treatment of Polypoidal Choroidal Vasculopathy With High Dose Ranibizumab (Lucentis): A Phase I 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
- Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.
研究概览
简要总结
This Phase I/II study will investigate the safety and tolerability of intravitreally administered 0.5mg and 1.0 or 2.0mg Ranibizumab in three monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month of drug safety follow up in subjects with exudative polypoidal choroidal vasculopathy (PCV) for a total of 24 months.
详细描述
Twenty eyes will be randomized will receive 3 consecutive monthly intravitreal 1.0 or 2.0 mg/0.5mg (3:1 ratio) Ranibizumab injection with the first injection occuring at Day 0 and second and third injection occuring at month 1 and month 2 respectively. Retreatment with intravitreal Ranibizumab or other therapies will be at the investigators discretion but guidelines for recommended retreatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and Females >18 years of age. Females of child bearing potential will undergo urine pregnancy testing and be required to use appropriate methods of birth control.
- •ICG and fluorescein angiographic characteristics consistent with active, leaking PCV with subfoveal lesions and/or subfoveal hemorrhage, lipid exudates, PED or fluid diagnosed within the past 6 months or diagnosed as newly active within the past 6 months. Subjects who completed the 24 month follow up in the original FVF3671s protocol may enter the study without necessarily demonstrating active exudative PCV at enrollment.
- •Best-Corrected ETDRS Visual Acuity at 4 meters between 20/20 - 20/
- •Lesion size - no limitations.
- •Lesions Characteristics - leaking lesions consistent with PCV. No limitations on hemorrhage, fibrosis or atrophy.
- •No therapy (includes non foveal laser, PDT, intravitreal steroids, TTT, radiotherapy, or anti-VEGF therapy) or intraocular surgery within the past 30 days for any condition.
- •Clear ocular media to allow for photography/angiography.
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study.
排除标准
- •Patients with features of age related macular degeneration such as abundant drusen and demographic features consistent with this diagnosis.
- •Allergy to Fluorescein, ICG, Iodine, Shellfish.
- •Pregnancy (positive pregnancy test)
- •Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
- •Participation in another simultaneous medical investigation or trial.
- •Exclude other anti-VEGF agents as therapy options.
- •History of previous subfoveal laser.
- •Advanced glaucoma (IOP > 25 or cup/disc ration > 0.8)
- •Any condition in the opinion of the investigator that would interfere with disease status/progression or jeopardize patients' participation in the study.
研究组 & 干预措施
Ranibizumab 1.0 or 2.0 mg (HIGH DOSE)
Intraocular injection of 1.0 or 2.0 mg/0.05 cc ranibizumab.
Photodynamic therapy with visudyne or laser photocoagulation or intravitreal steroids may be considered as monotherapy or in combination with Ranibizumab at the investigator's discretion if rescue criteria are met
干预措施: ranibizumab 0.5 or 2.0 mg/0.05 cc (Drug)
Ranibizumab 0.5 mg
Intraocular injection of 0.5 mg/0.05 cc ranibizumab.
Photodynamic therapy with visudyne or laser photocoagulation or intravitreal steroids may be considered as monotherapy or in combination with Ranibizumab at the investigator's discretion if rescue criteria are met
干预措施: ranibizumab 0.5 or 2.0 mg/0.05 cc (Drug)
结局指标
主要结局
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.
时间窗: 2 years
Examples include 30 letter loss, major subretinal hemorrhage, involving 75% or more clinical macula (arcade to arcade), disease related vitreous hemorrhage, injection-related endophthalmitis, 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
- Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters(3 Months)
- Number of Participants at Month 6 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters(6 months)
- Mean Best Corrected Visual Acuity Letter Change at 4 Meters Between Baseline and 12 Months(12 months)
- Change in Mean Central Foveal Thickness From Baseline(12 Months)
- Mean Change From Baseline in Total Area of FA CNV Leakage Over 12 Months(12 Months)
- Number of Participants at Month 9 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters(9 Months)
- Number of Participants at Month 12 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters(12 Months)
- Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12(12 months)
- Number of Participants at Month 3 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters(3 months)
- Number of Participants at Month 6 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters(6 months)
- Number of Participants at Month 9 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters(9 months)
- Number of Participants at Month 12 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters(12 months)
研究者
Dennis M. Marcus, M.D.
Dr. Dennis M. Marcus Principal Investigator
Southeast Retina Center, Georgia