2025-523478-17-00招募中4 期
Two initial aflibercept 8 mg loading doses in treatment-naive neovascular AMD
Medical University Of Graz1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年2月16日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of patients without disease activity at week 8.
研究概览
简要总结
The primary aim of this study is to investigate how effective 2 aflibercept 8 mg loading doses lead to a non-active disease.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients must be ≥50 years old on day
- •All patients must be nAMD (neovascular age-related macular degeneration) treatment-naïve on the study eye.
- •All AMDs must be type 1 or
- •Choroidal neovascularization lesion size have to be of nine or fewer disc areas.
- •For each participant, one eye will be chosen as the study eye. Should eligibility apply to both eyes, the one with the lower BCVA during the screening will be selected.
- •The diagnosis must be confirmed with fluorescein and/or indocyanine green angiography.
- •The BCVA should be between 78 - 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at day 1.
排除标准
- •Participation in another clinical trial during the last 4 weeks.
- •Any cataract surgery within 3 months before day 1 or already scheduled during the study period on the study eye.
- •Any other intraocular surgery on the study eye (e.g., pars plana vitrectomy, glaucoma surgery, corneal transplant).
- •Polypoidal choroidal vasculopathy (PCV) or type 3 AMD confirmed by fluorescein and/or indocyanine green angiography on the study eye.
- •Simultaneous participation in another clinical trial.
- •Subjects who receive any intraocular surgery during the study period on the study eye.
- •Pregnancy or breast-feeding.
- •Current chemotherapy.
- •Known intolerance/hypersensitivity to aflibercept 8 mg.
- •Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid (retinal detachment, diabetic maculopathy, epiretinal membrane with traction, central serous chorioretinopathy) on the study eye.
- •Retinal pigment epithelium (RPE) tear involving the macula on the study eye on day
- •>6 diopters of myopia on the study eye (For patients who have undergone previous refractive or cataract surgery, the preoperative refractive error should not have exceeded −6 diopters of myopia).
结局指标
主要结局
Proportion of patients without disease activity at week 8.
Proportion of patients without disease activity at week 8.
次要结局
- Proportion of patients with a 4, 6, 8, 10, 12, 14 or 16 week treatment interval between the 2nd aflibercept 8 mg loading dose and the 3rd aflibercept 8 mg injection
- Change in best corrected visual acuity from baseline to week 4 and 8.
- Change in central subfield thickness and macular fluid volume from baseline to week 4 and 8.
- Characteristics/measurements in optical coherence tomography (OCT), optical coherence tomography angiography (OCTA), angiography and best corrected visual acuity (BCVA) assessment, which can predict active/non-active disease.
研究者
Investigator
Scientific
Medical University Of Graz
研究点 (1)
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