Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab Prospectively
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- BCVA
研究概览
简要总结
This is a 24-month study of ranibizumab (2.0 mg and 1.0 mg) in subjects with polypoidal choroidal vasculopathy as diagnosed by fluorescein/indocyanine green (FA/ICG) angiography.
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
- 25 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •BCVA using ETDRS of 20/32 to 20/400
排除标准
- •Any history of previous vitrectomy
- •Any prior treatment with verteporfin photodynamic therapy in the study eye.
- •Previous cataract surgery within the preceding 2 months of Day 0
- •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 an 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-vascular endothelial growth factor (VEGF) (Macugen, Avastin, Lucentis) in the study eye prior within 30 days prior to enrollment in this study
- •Known allergy to any component of the study drug
- •Blood pressure >180/110 (systolic above 180 or diastolic above 110) If blood pressure if brought below 180/110 by anti-hypertensive treatment, the patient can become eligible.
- •Major surgery within 28 days prior to randomization or major surgery planned within the next 12 months. Major surgery is defined as a surgical procedure that is more extensive than needle biopsy/aspiration placement of a central venous access device, removal/biopsy of a skin lesion, or placement of a peripheral venous catheter.
- •Myocardial infraction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months prior to randomization.
- •Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomization.
- •History of recurrent significant infections or bacterial infections
- •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 spermicide gel, an intra uterine device (IUD), or contraceptive hormone implant or patch
- •Prior enrollment in the study
- •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.
研究组 & 干预措施
Cohort 1
12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab
干预措施: high-dose ranibizumab (Drug)
Cohort 1
12 monthly, intravitreal injections of 2.0mg ranibizumab followed by 12 monthly, intravitreal injections of 1.0mg ranibizumab
干预措施: ranibizumab (Drug)
Cohort 2
6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg
干预措施: high-dose ranibizumab (Drug)
Cohort 2
6-months of monthly, intravitreal injections of ranibizumab 2.0mg followed by 18 months of monthly, intravitreal injections of ranibizumab 1.0mg
干预措施: ranibizumab (Drug)
Cohort 3
24 months of monthly, intravitreal injections of ranibizumab 1.0mg
干预措施: ranibizumab (Drug)
结局指标
主要结局
BCVA
时间窗: Baseline to M24
Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters from Baseline to Month 24
次要结局
- BCVA(at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24)
- Fundus Clinical Findings(Baseline, Months 6, 12, 24)
- Ocular Adverse Events (AE)(Monthly)
- Macular Edema(Baseline, Day 14, Month 1-24)
- Systemic AEs(Monthly)
- PCV Anatomic Changes(Baseline, Months 6, 12, 24)
研究者
Gregg T. Kokame, MD
Medical Director, The Retina Center at Pali Momi
Hawaii Pacific Health