Intravitreal Aflibercept Injection for the Treatment of cHoroidAl Neovascularization seconDary to Presumed ocuLar Histoplasmosis syndromE.(the HANDLE Study)
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- ocular and systemic adverse events
研究概览
简要总结
The purpose of this study is to monitor safety outcomes for patients being treated with intravitreal aflibercept injections for choroidal neovascularization secondary to Presumed Ocular Histoplasmosis Syndrome.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Active choroidal neovascularization (CNV) secondary to presumed ocular histoplasmosis demonstrated by active leakage on fluorescein angiography with spectal domain OCT evidence of subretinal or intraretinal fluid or PED.
- •Active CNV may also be defined as demonstrating active subretinal hemorrhage.
- •ETDRS Best corrected visual acuity 20/20-20/
- •willing and able to comply with all study clinic visits and study related procedures.
- •Willing to use and practice more than one form of contraceptives during the 13 month study for male and female.
- •Provide signed informed consent
- •Able to understand and complete study related questionnaires
排除标准
- •Under 18 years of age
- •CNV due to other causes than Presumed Ocular Histoplasmosis
- •Previous treatment in the study eye within 6 months prior to Day 1
- •More than 5 Intravitreal injections of anti-VEGF therapy within previous 12 months
- •Any clinical evidence of any other ocular condition other than Ocular histoplasmosis
- •History of allergy to fluorescein
- •Pregnant( or planning on becoming pregnant within the next 13 months) or breast feeding women
- •Sexually Active Men or Women who are NOT willing to practice more than one form of contraceptives during the next 13 months.
- •Anticipated or previous (within previous 3 months) systemic anti-VEGF therapy
研究组 & 干预措施
intravitreal aflibercept injection
Group A -Monthly intravitreal aflibercept injection for 3 months (Baseline, Months 1 and 2), then mandatory every 2 months intravitreal aflibercept injection (Months 4,6, 8 and 10)for 12 months. Monthly visits with evaluations for as needed intravitreal aflibercept injection.
.
干预措施: aflibercept (Drug)
intravitreal aflibercept
Group B- One intravitreal aflibercept injection at Baseline, then monthly visits with evaluations for as needed dosing of intravitreal aflibercept injection for 12 months.
干预措施: aflibercept (Drug)
结局指标
主要结局
ocular and systemic adverse events
时间窗: through Month 12
The primary objective of the study is the incidence and severity of ocular and systemic adverse events through Month 12
次要结局
- Visual acuity(Months 3, 6, 9 and 12)
研究者
John Kitchens, MD
Sponsor-Investigator
Retina Associates of Kentucky