ACTRN12623000215628尚未招募4 期
A Phase IV, Prospective, Open Labelled, Single-arm, Multi-centered Study Assessing the Efficacy and Durability of Faricimab in Patients Currently Treated for Neovascular Age-Related Macular Degeneration.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- CUREOS
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 50 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.BCVA better than 20 letters as measured by an ETDRS chart (Snellen equivalent 6/120)
- •2.Previously treated neovascular age-related macular degeneration (nAMD), diagnosed within 36 months of the screening visit:
- •a.Subjects must have had at least 3 consecutive monthly injections (loading/initiation phase) of an anti-VEGF (ranibizumab or aflibercept) with a demonstrated early treatment response. An early treatment response is defined as:
- •i.Any reduction in retinal exudation (IRF and/or SRF) within the first 4 months of anti-VEGF treatment
- •b.Previous treatment with a single anti-VEGF agent (ranibizumab or aflibercept) following a treat-and-extend principle
- •c.First anti-VEGF injection within 36 months at screening
- •d.Most recent anti-VEGF injection between 1-3 months at screening
- •3.Active CNV, secondary to age-related macular degeneration (AMD) affecting the central subfield at screening
- •a.Active CNV is considered to be evidence of recurrent IRF and/or SRF affecting the central 3-mm subfield of the study eye, confirmed by confirmed by the Principal Investigator and central reading center (CRC) using spectral-domain optical coherence tomography (SD-OCT) and angiography
- •4.Availability of historical OCT imaging to demonstrate treatment response
- •5.Availability of comprehensive historical anti-VEGF injection data including anti-VEGF agent administered, total number and date of administration from the first anti-VEGF treatment for nAMD.
排除标准
- •Unless specified otherwise, ocular specific exclusion criteria apply to the study eye only.
- •1.CNV or retinal exudation due to causes other than typical AMD, such as vitelliform macular dystrophy, ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis
- •2.Active intraocular inflammation or suspected or active intraocular or periocular infection (eg, infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis) in either eye at Baseline
- •3.Central subfield of the study eye affected by fibrosis or geographic atrophy assessed by colour fundus photography autofluorescence.
- •4.Subretinal blood affecting the central subfield and/or greater than or equal to 50% of the lesion of the study eye
- •5.Any history or evidence of a concurrent intraocular condition in the study eye, including retinal diseases other than neovascular AMD, that, in the judgment of the Investigator, could either require medical or surgical intervention during the course of the study to prevent or treat visual loss that might result from that condition, or that limits the potential to gain visual acuity upon treatment with the investigational product
- •oCataract surgery during the study is permitted at the discretion of the investigator.
- •6.Retinal pigment epithelium (RPE) rip/tear in the study eye at Baseline
- •7.Current vitreous haemorrhage or history of vitreous haemorrhage in the study eye within 4 weeks prior to Baseline
- •8.History of rhegmatogenous retinal detachment, stage 3/4 macular hole or any retinal break unless adequate repair has been performed
- •9.History of the following in the study eye:
- •oPrevious pars plana vitrectomy
- •oPrevious treatment with anti-VEGF other than ranibizumab or aflibercept (e.g. brolucizumab or bevacizumab)
- •oPrevious photodynamic therapy (PDT)
- •oIntraocular or refractive surgery within the 90-day period prior to Baseline
- •oPrevious penetrating keratoplasty or vitrectomy
- •oPrevious panretinal photocoagulation
- •oPrevious submacular surgery, other surgical intervention or laser treatment for AMD
- •10.Uncontrolled glaucoma or ocular hypertension in the study eye defined as intraocular pressure (IOP) > 25 mmHg on medication or according to Investigator’s judgment at Baseline
- •11.Intra- or periocular use of corticosteroids in the study eye during the 6-month period prior to Baseline
- •12.Use of topical ocular corticosteroids in the study eye for 60 or more consecutive days within the 90-day period prior to Baseline
- •13.Use of systemic corticosteroids for 30 or more consecutive days within the 90 days prior to Baseline, with the exception of low stable doses of corticosteroids (defined as less than or equal to 10 mg prednisolone or equivalent dose used for 90 days or more). Inhaled, nasal or dermal steroids are also permitted
- •14.Previous therapeutic radiation near the region of the study eye
- •15.History of a medical condition (disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding) that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product
- •16.History of hypersensitivity to any component of the test article or clinically relevant sensitivity to fluorescein dye (or indocyanine green), as assessed by the Investigator
- •17.Participation in an investigational drug, biologic, or device study within 30 days or the
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