Open-label, Non-randomized, Unmasked, Study of IAI in Patients Which Choroidal Neovascularization Secondary to Polypoidal Choroidal Vasculopathy (PCV)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence and Severity
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of intravitreal aflibercept injection (IAI) in patients with neovascular polypoidal choroidal vasculopathy.
详细描述
This is an open-label, non-randomized, unmasked, study of IAI in patients with choroidal neovascularization secondary to polypoidal choroidal vasculopathy (PCV). Twenty treatment naïve and previously treated PCV eyes will be enrolled (only one study eye per patient will be enrolled). A maximum of 10 previously treated eyes will be enrolled. Consented, enrolled patients will be followed monthly. All patients will receive monthly IAI 2.0 mg intravitreally for 3 months (Baseline, Months 1 and 2), followed by mandatory IAI 2.0 mg every 2 months (Months 4, 6, 8 and 10) for 12 months. Patients can receive additional IAI treatment (Months 3, 5, 7, 9, and 11) if the re-treatment criteria are met. Starting at Month 3, patients can receive non-anti vascular endothelial growth factor (VEGF) rescue therapy (ie: Photodynamic Therapy (PDT), laser, intravitreal steroids) if the pre-defined criteria are met.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Best corrected early treatment of diabetic retinopathy study (ETDRS) visual acuity at 4 meters between 20/20 - 20/400 (BCVA ETDRS letter score 85 - 20 letters in the study eye)
- •Lesion Characteristics - leaking lesions consistent with PCV. (No limitations on hemorrhage, fibrosis or atrophy)
- •Clear ocular media to allow for photography/angiography
- •Willing and able to comply with clinic visits and study-related procedures
- •Patients with bilateral disease will only be able to enroll one eye
- •Provide signed informed consent
排除标准
- •Any history of systemic Anti-VEGF therapy
- •Current ocular or periocular infection
- •Active intraocular inflammation
- •Any comorbid condition that may decrease visual acuity
- •Any patients who have had intraocular surgery within the past 30 days for any condition
- •For treatment naïve patients: No prior anti-VEGF, PDT, intravitreal steroids or laser (subfoveal or non foveal)
- •For previously-treated patients :
- •Prior anti-VEGF (ranibizumab, bevacizumab, pegaptanib) within 30 days
- •Prior IAI
- •Prior PDT , transpupillary thermal therapy (TTT) or radiation within 90 days (a maximum of 3 PDTs allowed)
- •Prior intravitreal steroids within 90 days
- •Prior non-foveal laser within 90 days
- •Prior subfoveal laser
- •Patients with features of dry age-related macular degeneration such as abundant drusen and symptoms/demographic features inconsistent with the diagnosis of PCV
- •Allergy to fluorescein, ICG, iodine, shellfish
- •Any other condition that the investigator believes would pose a significant hazard to the patient if the investigational therapy were initiated
- •Participation in another simultaneous medical investigation or trial
- •History of previous subfoveal laser
- •Advanced glaucoma (IOP > 25 or cup/disc ratio > 0.8)
- •Pregnant or breast-feeding women
- •Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device (IUD); bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly) *Contraception is not required for men with documented vasectomy. **Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
研究组 & 干预措施
Intravitreal Aflibercept Injection
All patients will receive monthly IAI 2.0 mg intravitreally for 3 months (Baseline, Months 1 and 2), followed by mandatory IAI 2.0 mg every 2 months (Months 4, 6, 8 and 10) for 12 months.
干预措施: Rescue Intravitreal Aflibercept Injection (Drug)
Intravitreal Aflibercept Injection
All patients will receive monthly IAI 2.0 mg intravitreally for 3 months (Baseline, Months 1 and 2), followed by mandatory IAI 2.0 mg every 2 months (Months 4, 6, 8 and 10) for 12 months.
干预措施: Rescue Therapy with PDT, Laser or Intravitreal Steroids (Procedure)
结局指标
主要结局
Incidence and Severity
时间窗: Month 12
The primary objective of the study is the incidence and severity of ocular and systemic adverse events at Month 12.
次要结局
- Change in Best Corrected Visual Acuity (BCVA)(Months 6 and 12)
- Photography Assessments(Months 6 and 12)