Study to Assess the EffectiVeness of exIsting Anti-vascular Endothelial groWth Factor (Anti-VEGF) Treatment Regimens in Patients With Wet Age-related Macular Degeneration

Overview

Retrospective, non-interventional, observational multi-center field study. Patients diagnosed with wet Age-related macular degeneration (wAMD) and having started treatment with ranibizumab between January 1, 2009 and December 31, 2009 must be consecutively screened and, if eligible, enrolled. Patients will be followed up at maximum until December 31, 2011. Switch to any other Anti vascular endothelial growth factor (anti VEGF) treatment will be documented. For each patient, demographics, medical history, administered treatments, results of ocular and visual assessments and other tests (where available) will be documented.

Full Title of Study: “Review Study: A Retrospective Noninterventional Study to Assess the EffectiVeness of exIsting Anti-vascular Endothelial groWth Factor (Anti-VEGF) Treatment Regimens in Patients With Wet Age-related Macular Degeneration”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: April 2013

Interventions

  • Drug: Ranibizumab
    • Patients with wet AMD treated with ranibizumab as prescribed by physician

Arms, Groups and Cohorts

  • Group 1

Clinical Trial Outcome Measures

Primary Measures

  • Changes in visual acuity after start of Anti vascular endothelial growth factor (anti VEGF) therapy with ranibizumab, assessed by Early Treatment Diabetic Retinopathy (ETDRS) or Snellen chard
    • Time Frame: Baseline and 24 months

Secondary Measures

  • Demographic characteristics of patients included in the study (Age, Sex, Race)
    • Time Frame: Baseline
  • Mean time from first clinical presentation to diagnosis
    • Time Frame: Baseline
  • Mean time from diagnosis to treatment
    • Time Frame: Time from diagnosis to treatment: Up to 24 months
  • Mean time from diagnosis to end of follow-up
    • Time Frame: Time from diagnosis to end of follow-up: up to 48 months
  • Mean change of visual acuity, from diagnosis to end of follow-up, assessed by Early Treatment Diabetic Retinopathy (ETDRS) or Snellen chart
    • Time Frame: Baseline and 24 months
  • Mean change of retinal thickness from diagnosis to end of follow-up, assessed by Optical Coherence Tomography (OCT)
    • Time Frame: Baseline and 24 months
  • Mean change of lesion size from diagnosis to end of follow-up, assessed by Fluorescein Angiography (FA)
    • Time Frame: Baseline and 24 months
  • Average number of treatments given from diagnosis to end of follow-up
    • Time Frame: After 24 months

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of wet Age-related Macular Degeneration – Start of anti-VEGF therapy with ranibizumab (Lucentis) between January 1, 2009 and December 31, 2009 – Informed consent form signed Exclusion Criteria:

  • Participation in an investigational study during anti-VEGF therapy (from start up to December 31, 2011) that involved treatment with any drug or device

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

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