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临床试验/EUCTR2014-001085-10-DE
EUCTR2014-001085-10-DE进行中（未招募）1 期

A phase IV, prospective, open label, uncontrolled, European study in patients with neovascular age-related macular degeneration (nAMD), evaluating the efficacy and safety of switching from intravitreal aflibercept to ranibizumab 0.5mg : the SAFARI study - SAFARI

ovartis Pharmaceuticals UK Ltd0 个研究点目标入组 124 人开始时间: 2014年7月30日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
发起方
入组人数
124
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

  • •Inclusion criteria for patient
  • •1. Written informed consent must be obtained before any assessment is performed.
  • •2. Age =50 years.
  • •3. BCVA =23 ETDRS letters, at both the Screening Visit and Baseline Visit in the Study eye.
  • •4. Active, angiographically documented CNV lesion in study eye (e.g. leakage on fluorescein angiography plus intraretinal, subretinal or sub-retinal pigment epithelium (RPE) fluid on SD/HD-OCT) secondary to AMD at Screening.
  • •5. Evidence of active CNV involving the center of the fovea in the study eye (e.g. pigment epithelium detachment, subretinal or sub-RPE hemorrhage, macular edema, or subretinal, sub-RPE or intraretinal fluid) at Baseline.
  • •6. The total area of fibrosis in the study eye comprising less than 50% of the lesion area.
  • •Patient subgroup specific inclusion criteria
  • •Patients need to meet all the criteria for one of the following two groups:
  • •Group 1. Primary treatment failure
  • •7. No prior anti-VEGF treatment prior to initiating aflibercept.
  • •8. Received no more than 3 injections of aflibercept into the study eye prior to the Screening Visit.
  • •9. Historical OCT volume scan acquired <= 28 days before the first aflibercept injection was administered to the study eye.
  • •10. Initiated treatment with aflibercept <130 days prior to the Screening Visit.
  • •11. Last injection of aflibercept was =28 days but =40 days prior to the Baseline visit.
  • •12. No increase in BCVA (=5 letters) since commencing treatment with aflibercept.
  • •13. Disease activity has never been controlled in the study eye after initiating aflibercept as defined by at least one of the following observed on a historical OCT volume scan acquired after a minimum of 2 aflicerpt injections: evidence of unchanged or increasing retinal or sub-retinal fluid; new PED; unchanged or increasing size of pre-existing
  • •Group 2. Suboptimal treatment response
  • •14. No prior anti-VEGF treatment prior to initiating aflibercept.
  • •15. Aflibercept commenced =6 months prior to the Screening Visit.
  • •16. Received =3 aflibercept injections into the study eye within 6 months of the Screening Visit.
  • •17. Historical OCT volume scan acquired <= 28 days before the first aflibercert injection was administered to the study eye.
  • •18. Evidence of previous reduced disease activity in the study eye after initiating aflibercept as defined by reduction of =50µm in central subfield retinal thickness observed on a historical OCT volume scan after a minimum of 2 aflibercept injections.
  • •19. Last injection of aflibercept was =28 days but =70 days prior to the Baseline visit.
  • •20. At Screening Visit, disease activity has worsened (as defined by increasing retinal* or sub-retinal fluid, or new or increasing size of PED) in the study eye compared to prior visits.
  • •*Evidence of increasing retinal fluid may include increased number, size or total volume of IRCs, or increased central retinal or foveal thickness, or similar quantitative retinal imaging data recorded within the individual patient record.
  • •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 15
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 109

排除标准

  • •Exclusion criteria for patient
  • •1. Inability to comply with study or follow-up procedures.
  • •2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
  • •3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
  • •Exclusion criteria for systemic medical history and conditions
  • •4. History of cerebrovascular accident, transient ischemic attack or myocardial infarction within 3 months of the Screening visit.
  • •5. Any type of systemic disease or its treatment, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk.
  • •6. Uncontrolled blood pressure defined as a persistent systolic value of >160 mm Hg or persistent diastolic value of >100 mm Hg at Screening or Baseline.
  • •7. Simultaneous participation in any other clinical study for the duration of this study.
  • •8. Use of other investigational drugs (excluding vitamins and minerals) or participation in any other clinical study within 90 days or 5 half-lives of the Screening visit, or until the expected pharmacodynamic effect has resolved, whichever is longer.
  • •9. History of hypersensitivity to either ranibizumab (or any component of the ranibizumab formulation), or fluorescein, or indocyanine green, or to drugs of similar chemical classes.
  • •Exclusion criteria for ocular medical history and conditions
  • •For either eye
  • •10. Any active periocular or ocular infection or inflammation (e.g., blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) at the time of Screening or Baseline.
  • •11. Uncontrolled glaucoma (intraocular pressure [IOP] =30 mm Hg on medication or
  • •according to Investigator’s judgment) at the time of Screening or Baseline.
  • •12. Evidence of bilateral active CNV during the Screening Period or at Baseline requiring bilateral anti-VEGF injections. Patients with active CNV in the study eye with quiescent CNV in the fellow eye who may have received IVT aflibercept or ranibizumab injections into the fellow eye >40 days prior to the Screening visit are not excluded from the study; however, should the fellow eye require anti-VEGF treatment during the study only ranibizumab may be utilized.
  • •13. Prior intravitreal injection of ranibizumab or bevacizumab into the study eye and/or prior intravitreal injection of bevacizumab into the fellow eye
  • •Study eye exclusion criteria
  • •14. At Baseline, intraocular surgery was performed within the previous 28 days or intraocular surgery is planned at any time during the 6 month study period.
  • •15. Cataract (if causing significant visual impairment), aphakia, severe vitreous hemorrhage, rhegmatogenous retinal detachment, proliferative retinopathy or choroidal neovascularization of any other cause for CNV other than wet AMD (e.g., ocular histoplasmosis, pathologic myopia (=-8 dioptres)) at the time of Screening and Baseline.
  • •16. Irreversible structural damage involving the center of the fovea (e.g. advanced fibrosis or geographic atrophy) which in the opinion of the Investigator is sufficient to irreversibly impair visual acuity.
  • •17. Polypoidal chor

研究者

发起方
ovartis Pharmaceuticals UK Ltd

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