NCT01961414Unknown4 期
Treat and Extend Therapy Using Intravitreal Aflibercept (IAI) for Previously Treated Patients Exiting the Wet Age-related Macular Degeneration Extension Study (0910)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 45
- 试验地点
- 6
- 主要终点
- Portion of patients who maintain vision (loss of < or = 5 letters ETDRS BCVA) from baseline to Year 1.
研究概览
简要总结
The purpose of this research study is to determine if a "Treat and Extend" regimen (increasing the time between visits when the disease is stable and not getting worse) of aflibercept 2.0mg injections inside the eye for treating patients with Wet Age-related Macular Degeneration.
详细描述
After exiting VGFT-OD 0910, patients will be enrolled into RANGE, a longterm extension trial evaluating the safety and efficacy of aflibercept IAI utilizing a "treat and extend" regimen. Using pre-specified re-treatment criteria, treatment intervals will be variable with dosing of the active treatment at least every 12 weeks.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous enrollment in 0910-extension study evaluating intravitreal aflibercept injection (NCT 00964795) without early study discontinuation prior to sponsor early termination.
- •Patients are enrolled within 90 days of site activation (all attempts will be made to ensure IAI is given once exited from the 0910-extension and prior to enrollment).
- •Willing and able to comply with clinical visits and study related procedures.
- •Provide signed informed consent
排除标准
- •Prior treatment with verteporfin, or external-beam radiation therapy, or transpupillary thermotherapy in the study eye
- •Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
- •History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye
- •Any concurrent intraocular condition in the study eye (e.g. diabetic retinopathy or glaucoma) that, in the opinion of the investigator, could either
- •require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition, or
- •if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the study period
- •Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye
- •Current vitreous hemorrhage in the study eye
- •History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
- •Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- •Aphakia, ACIOL, or unstable PCIOL
- •Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)
- •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
Aflibercept
Experimental
All patients will receive aflibercept 2.0mg intravitreal injection
干预措施: Aflibercept (Drug)
结局指标
主要结局
Portion of patients who maintain vision (loss of < or = 5 letters ETDRS BCVA) from baseline to Year 1.
时间窗: 1 Year
次要结局
未报告次要终点
研究者
研究点 (6)
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