A Randomized, Single-blinded, Multicenter, Phase IV Study to Compare Systemic VEGF Protein Dynamics Following Monthly Intravitreal Injections of 0.5 mg Ranibizumab Versus 2 mg Aflibercept Until Study Week 12 in Patients With Neovascular (Wet) Age-related Macular Degeneration
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Standardized Area Under the Curve (AUC) for VEGF A Levels by SIMOA (Quanterix's Single Molecule Array) Method for the Comparative Phase
研究概览
简要总结
The purpose of the study was to compare the effect of intravitreal injections of ranibizumab and aflibercept on systemic VEGF protein levels in treatment naïve wet neovascular Age-related Macular Degeneration (wAMD) patients in a detailed time course.
详细描述
A planned study visit schedule was established at the time of baseline visit (day 1) for all patients. Study assessments for patients were performed at screening visit, baseline (day 1), day 2, day 8 (± 1 day to allow for flexibility in scheduling) and as of day 15 through to day 169 at biweekly visits.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Visual impairment predominantly due to neovascular AMD.
- •Active, newly diagnosed, untreated, angiographically documented, CNV lesion (i.e. leakage on fluorescein angiography plus intraretinal, subretinal or sub-RPE fluid on OCT) secondary to neovascular AMD in line with SmPC of ranibizumab and aflibercept
排除标准
- •Stroke or myocardial infarction less than 3 months prior to screening.
- •Presence of uncontrolled systolic blood pressure or diastolic blood pressure
- •Type 1 or Type 2 diabetes mellitus
- •Use of any systemic anti-VEGF drugs
- •Use of systemic or inhaled corticosteroids for at least 30 consecutive days within 3 months prior to screening.
- •Women who are pregnant or breast feeding or who are menstruating and capable of becoming pregnant* and not practicing a medically approved method of contraception
- •For either eye:
- •Any active periocular or ocular infection or inflammation
- •Uncontrolled glaucoma
- •Neovascularization of the iris or neovascular glaucoma
- •History of treatment with any anti-angiogenic drugs
- •For study eye:
- •Atrophy or fibrosis involving the center of the fovea at the time of screening or baseline.
- •Cataract (if causing significant visual impairment), planned cataract surgery during the study period, vitrectomy, aphakia, glaucoma surgery, severe vitreous hemorrhage, rhegmatogenous retinal detachment, proliferative retinopathy or choroidal neovascularization of any other cause than wAMD
- •Irreversible structural damage within 0.5 disc diameter of the center of the macula
- •Any intraocular procedure (including cataract surgery, Yttrium-Aluminum-Garnet capsulotomy) within 3 months prior to baseline or anticipated within the next 6 months following baseline.
- •Use of intravitreal or topical ocular corticosteroids administered for at least 30 consecutive days within 3 months prior to screening.
- •For fellow eye
- •Retinal or choroidal neovascularization or macula edema of any cause
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Group 1
6 monthly intravitreal injections of 0.5 mg ranibizumab
干预措施: Ranibizumab 0.5 mg (Drug)
Group 2
3 monthly intravitreal injections of 2 mg aflibercept followed by 3 monthly intravitreal injections of 0.5 mg ranibizumab
干预措施: Ranibizumab 0.5 mg (Drug)
Group 2
3 monthly intravitreal injections of 2 mg aflibercept followed by 3 monthly intravitreal injections of 0.5 mg ranibizumab
干预措施: Aflibercept 2 mg (Drug)
结局指标
主要结局
Standardized Area Under the Curve (AUC) for VEGF A Levels by SIMOA (Quanterix's Single Molecule Array) Method for the Comparative Phase
时间窗: Baseline up to Week 12 visit (Days 1, 2, 8, 15, 29, 43, 57, 71, 85)
The AUC was calculated using the trapezoidal rule, where all available measurement between Day 1 and Week 12 were used. The AUC was standardized by dividing the calculated value by the number of days from first to last measurement.
次要结局
- Systemic VEGF-A Protein Levels From Study Week 12 to 24(From study week 12 to 24 (Days 85, 99, 113, 127, 141, 155, 169))
- Systemic VEGF-A Levels From Study Week 12 to 24 (Change From Baseline)(From study week 12 to 24)