2024-515497-26-00招募中4 期
Aflibercept 8mg for high-frequent Faricimab and prior Aflibercept 2mg treated Neovascular age-related macular degeneration: a monocenter, single-arm, open-label extension study (A-FAN)
Medical University Of Graz1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2024年9月22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
- 33
- 试验地点
- 1
- 主要终点
- proportion of eyes with at least one extension without retinal (intra- and subretinal) fluid within the time period baseline to 32 weeks (extension success rate)
研究概览
简要总结
To assess the efficacy of aflibercept 8mg in terms of durability at 32 weeks by extending treatment interval in previous high-frequent faricimab and prior aflibercept 2mg treated neovascular age-related macular degeneration.
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
- •prior participation in the FAN study
- •signed written informed consent
- •willingness and ability to comply with clinic visits and study-related procedures
- •≥50 years of age
- •MNV due to AMD (nAMD)
- •BVCA between and including 19 and 75 letters (Snellen equivalent approximately 20/400 to 20/32)
- •≥ 4 previous intravitreal injections with faricimab
- •eyes remaining on a treatment interval of ≤35 days and/or
- •did/do not meet extension success with faricimab, hence had/has retinal (intra- and or subretinal) fluid at 6 weeks
排除标准
- •uncontrolled blood pressure (either/both systolic blood pressure >180mmHg, diastolic blood pressure >100mmHg)
- •MNV due to other causes than nAMD
- •polypoidal choroidal neovascularization
- •retinal pigment epithelial rip/tear
- •subretinal hemorrhage of > 50% of the lesion, involving the fovea
- •any macular pathology other than AMD causing structural changes of the macula and thereby affecting vision
- •any active intra-/periocular infection/inflammation of the study eye
- •uncontrolled glaucoma under medication (IOP >25mmHg)
- •breast-feeding
- •myocardial infarction or stroke within the last six months
- •concomitant participation in another clinical study with investigational medicinal products
- •a known allergy or hypersensitivity towards eye drops needed for the examinations planned during the study, and/or the intravitreal procedure.
- •a known allergy or hypersensitivity towards any of the components of the study drug
- •Persons unable to give consent or cannot understand the purpose of the study (dementia, etc.), or should be excluded by investigator's decision
- •treatment interval ≥ 6weeks without retinal (intra- and/or subretinal) fluid on OCT
结局指标
主要结局
proportion of eyes with at least one extension without retinal (intra- and subretinal) fluid within the time period baseline to 32 weeks (extension success rate)
proportion of eyes with at least one extension without retinal (intra- and subretinal) fluid within the time period baseline to 32 weeks (extension success rate)
次要结局
- proportion of eyes with maximum extended interval without retinal (intra- and subretinal) fluid of ≥ 6, ≥ 8 and ≥ 10 weeks at 32 weeks
- maximum extended treatment interval without retinal (intra- and subretinal) fluid at 32 weeks
- number of injections received during 32 weeks
- proportion of eyes remaining on a 4-weekly interval from baseline to last visit (completed interval) at 32 weeks
- proportion of eyes extended to 6 weeks, without success (intra- and or subretinal fluid present) from baseline to 32 weeks
- mean change in ETDRS letter score from baseline to an averaged ETDRS letter score between 24 and 32 weeks
- mean averaged ETDRS letter score between 24 and 32 weeks
- proportion of eyes gaining ≥ 5 ETDRS letters from baseline to an averaged ETDRS letter score between 24 and 32 weeks
- proportion of eyes loosing ≥5 ETDRS letters from baseline to an averaged ETDRS letter score between 24 and 32 weeks
- mean change in low-luminance BCVA from baseline over time
- mean CST change from baseline (1mm ETDRS grid) to an averaged CST between 24 and 32 weeks
- mean CST change from baseline to maximum extended interval without retinal (intra- and subretinal) fluid
- proportion of eyes with no intraretinal fluid at baseline and final visit (completed interval) at or before 32 weeks
- proportion of eyes with no subretinal fluid at baseline and final visit (completed interval) at or before 32 weeks
- proportion of eyes with no retinal (intra- and subretinal) fluid at baseline and final visit (completed interval) at or before 32 weeks
- retinal nerve fiber analysis over time
- incidence and severity of ocular/non-ocular adverse events
- mean change in concentration of plasma VEGF-A over time
研究者
Coordination Center for Clinical Trials
Scientific
Medical University Of Graz
研究点 (1)
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