2024-515377-10-00招募中4 期
Faricimab for high-frequent Aflibercept treated Neovascular age-related macular degeneration: a monocenter, randomized, double-masked comparator-controlled study (FAN study)
Medical University Of Graz, Medical University Of Graz1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年11月18日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 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 faricimab compared to aflibercept in terms of durability at 32 weeks by extending treatment interval in previous high-frequent aflibercept treated neovascular age-related macular degeneration.
详细描述
There is a subgroup of nAMD patient requiring monthly interventions, when applying as needed and treat-and-extend treatment strategies. A burden for both patient/caregivers and health care systems. More durable treatment options are needed to increase the quality of life for these nAMD patients, as well as to make human resources available for the growing elderly AMD population requiring treatment.
The FAN study is a randomized, double-masked, 2-arm (comparator-controlled), phase-IV, monocenter study with a primary endpoint at 32 weeks. The study is conducted into 2 parts. Patients will receive either aflibercept or faricimab via treat-and-extend principle until the primary endpoint (part 1). As mentioned, the main objective is to assess the durability of both drugs in this particular subgroup of nAMD patients. In part 2 of the study, starting at or after 32 weeks, all patients will receive faricimab via treat-and-extend until the end of the study (56 weeks).
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •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)
- •≥ 7 previous intravitreal injections with anti-VEGF
- •the last ≥ 4 consecutive intravitreal injections with aflibercept
- •the last aflibercept injections within the last 35 days
- •interval between the last 2 aflibercept injections ≤ 35 days
排除标准
- •use of long-term systemic corticosteroids within the last 3 months
- •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)
- •cataract surgery of the study eye within the last 3 months
- •previous intraocular surgery of the study eye other than cataract surgery or intravitreal injections with anti-VEGF (e.g. vitrectomy, corneal transplant, glaucoma surgery)
- •any previous laser therapy of the study eye other than Yag (yttrium aluminium garnet) laser capsulotomy (e.g. panretinal photocoagulation, verteporfin photodynamic therapy)
- •uncontrolled blood pressure (either/both systolic blood pressure >180mmHg, diastolic blood pressure >100mmHg)
- •refractive error of more than -6 diopters myopia
- •vitreous hemorrhage
- •retinal detachment
- •pregnancy (pre-menopausal women MUST take a pregnancy test at time of initiation)
- •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 against fluorescein / indocyanine green used during angiography
- •a known allergy or hypersensitivity towards any of the components of the study drug
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
- mean change in concentration of plasma VEGF-A, Ang-2 over time
- proportion of eyes with maximum extended interval without retinal (intra- and subretinal) fluid of ≥ 6, ≥ 8 and ≥ 10 weeks at 32 weeks
- change in NEI VFO-25 total score over time
- maximum extended treatment interval without retinal (intra- and subretinal) fluid at 32 weeks
- number of injections received during 32 weeks
- proportion of eyes with maximum extended interval without retinal (intra-and subretinal) fluid of ≥ 6, ≥ 8, ≥ 10 and ≥12weeks at 56 weeks
- proportion of eyes remaining on a 4-weekly interval from baseline to last visit (completed interval) at 56 weeks
- maximum extended treatment interval without retinal (intra- and subretinal) fluid at 56 weeks
- number of injections received during 1 year
- mean change in EDTRS letter score from baseline to an averaged EDTRS letter score between 24 and 32 weeks
- mean averaged EDTRS letter score between 24 and 32 weeks
- mean change in EDTRS letter score from baseline to an averaged EDTRS letter score between 48 and 56 weeks
- mean averaged EDTRS letter score between 48 and 56 weeks
- proportion of eyes gaining ≥ 5 EDTRS letters from baseline to an averaged EDTRS letter score between 24 and 32 weeks
- proportion of eyes loosing ≥5 EDTRS letters from baseline to an averaged EDTRS letter score between 24 and 32 weeks
- proportion of eyes gaining ≥ 5 EDTRS letters from baseline to an averaged EDTRS letter score between 48 and 56 weeks
- proportion of eyes loosing ≥5 EDTRS letters from baseline to an averaged EDTRS letter score between 48 and 56 weeks
- mean change in low-luminance BCVA from baseline over time
- mean CST change from baseline (1mm EDTRS grid) to an averaged CST between 24 and 32 weeks
- mean CST change from baseline (1mm EDTRS grid) to an averaged CST between 48 and 56 weeks
- proportion of eyes with no intraretinal fluid at baseline, last visit (completed interval) at or before 32 weeks and at or before 56 weeks
- proportion of eyes with no subretinal fluid at baseline, last visit (completed interval) at or before 32 weeks and at or before 56 weeks
- proportion of eyes with no retinal (intra- and subretinal) fluid at baseline, last visit (completed interval) at or before 32 weeks and at or before 56 weeks
- retinal nerve fiber analysis over time
- incidence and severity of ocular/non-ocular adverse events
- initial concentration of plasma VEGF-A, Ang-2
研究者
Coordination center for Clinical Trials
Scientific
Medical University Of Graz
研究点 (1)
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