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临床试验/EUCTR2019-004145-33-FR
EUCTR2019-004145-33-FR进行中（未招募）1 期

A one-year, single-arm, open-label, multicenter study assessing the effect of brolucizumab on disease control in adult patients with suboptimal anatomically controlled neovascular age-related macular degeneration (SWIFT) - SWIFT

ovartis Pharma S.A.S0 个研究点目标入组 362 人开始时间: 2019年12月18日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
发起方
入组人数
362
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •Patients must provide written informed consent before any study-related procedures are performed.
  • •Patients must be 50 years of age or older at Screening/Baseline.
  • •Active CNV lesions secondary to nAMD diagnosed < 18 months prior to Screening/Baseline that affect the central subfield, including retinal angiomatous proliferation (RAP) with a CNV component, confirmed by presence of active leakage from CNV seen by fluorescein angiography (FA) and sequelae of CNV, e.g. pigment epithelial detachment (PED), subretinal hemorrhage or sub-retinal pigmented epithelium (sub RPE) hemorrhage, blocked fluorescence, or macular edema.
  • •Previous treatment with only one licensed anti-VEGF drug (i.e. Lucentis®, Eylea®) with residual fluid (intraretinal fluid (IRF) or subretinal fluid (SRF) that affects the central subfield under, as seen by OCT), despite a = Q4 and = Q8 treatment (treatment interval of 26 to 62 days inclusive) with licensed anti-VEGF. Patients must have received at least 3 injections of this anti-VEGF drug in the 6 months prior to Screening/Baseline.
  • •Best-corrected visual acuity (BCVA) score must be = 83 and = 38 letters at 4 meters starting distance using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts at Screening/Baseline
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 85
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 277

排除标准

  • •Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis) in either eye at Screening/Baseline.
  • •Presence of amblyopia, amaurosis, or ocular disorders in the fellow eye with BCVA < 35 ETDRS letters at Screening/Baseline (except when due to conditions whose surgery may improve visual acuity, e.g. cataract).
  • •Poor quality of OCT images at Screening/Baseline.
  • •Atrophy or fibrosis involving the center of the fovea in the study eye, as assessed by CFP and fundus autofluorescence (FAF).
  • •The total area of fibrosis or subretinal blood affecting the foveal center point comprising = 50% of the lesion area in the study eye.
  • •Concomitant conditions or ocular disorders in the study eye, including retinal diseases other than nAMD, that, in the judgment of the Investigator, could 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.
  • •Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 mmHg on medication or according to Investigator’s judgment.
  • •Previous laser treatment for nAMD including photodynamic therapy (PDT) laser at any time prior to Screening/Baseline.
  • •Systemic conditions or treatments
  • •Stroke or myocardial infarction in the 6-month period prior to Screening/Baseline.
  • •Systemic anti-VEGF therapy at any time.
  • •Women of childbearing potential, defined as all women less than 1 year postmenopausal or less than 6 weeks since sterilization.

研究者

发起方
ovartis Pharma S.A.S

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