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 sites124 target enrollmentJuly 30, 2014

DrugsLucentis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: ovartis Pharmaceuticals UK Ltd
Enrollment: 124
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 30, 2014

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ovartis Pharmaceuticals UK Ltd

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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.