check_circleStudy Completed

Ophthalmology, Macular Degeneration

Bayer Identifier:

15913

ClinicalTrials.gov Identifier:

NCT01447043

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to Assess the Effectiveness of Existing Anti vascUlar Endothelial Growth Factor (Anti VEGF) in Patients With Wet Age-related Macular Degeneration (wAMD) (AURA)

Trial purpose

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 August 31, 2009 must be consecutively screened and, if eligible, enrolled. Patients will be followed up at maximum until August 31, 2011. Switch to any other Anti vascUlar endothelial growth factor (anti VEGF) treatment will be documented and followed up. For each patient, demographics, medical history, administered treatments, results of ocular and visual assessments and other tests (where available) will be documented.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Diagnosis of wet age-related macular degeneration
    - Start of Anti vascUlar endothelial growth factor (anti VEGF) therapy with ranibizumab between January 1, 2009 and August 31, 2009
    - Informed consent form signed, where required


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

Trial summary

Enrollment Goal
2609
Trial Dates
January 2009 - November 2012
Phase
N/A
Could I Receive a placebo
No
Products
No Drug
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Germany
Completed
Many Locations, United Kingdom
Completed
Many Locations, France
Terminated
Many Locations, Japan
Completed
Many Locations, Italy
Terminated
Many Locations, Australia
Completed
Many Locations, Venezuela
Completed
Many Locations, Ireland
Completed
Many Locations, Canada
Completed
Many Locations, Netherlands

Primary Outcome

  • 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
    date_rangeTime Frame:
    Baseline and 24 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Demographic characteristics of patients included in the study (Age, Sex, Race)
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Mean time from first clinical presentation to diagnosis
    date_rangeTime Frame:
    Time from first clinical presentation to diagnosis: Up to 36 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean time from diagnosis to treatment
    date_rangeTime Frame:
    Time from diagnosis to treatment: Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean time from diagnosis to end of follow-up
    date_rangeTime Frame:
    Time from diagnosis to end of follow-up: 48 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean change of visual acuity, from diagnosis to end of follow-up, assessed by Early Treatment Diabetic Retinopathy (ETDRS) or SNELLEN
    date_rangeTime Frame:
    Baseline and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean change of retinal thickness from diagnosis to end of follow-up, assessed by Optical Coherence Tomography (OCT)
    date_rangeTime Frame:
    Baseline and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean change of lesion size from diagnosis to end of follow-up, assessed by Fluorescein Angiography (FA)
    date_rangeTime Frame:
    Baseline and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Average number of treatments given from diagnosis to end of follow-up
    date_rangeTime Frame:
    After 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Vital Signs (blood pressure, heart rate, temperature) of patients included in the study
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Medical and surgical history (diseases and surgeries) of patients included in the study
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No

Trial design

AURA study: A retrospective non-interventional study (NIS) to assess the effectiveness of existing Anti vascUlar endothelial growth factor (anti VEGF) treatment Regimens in patients with wet Age-related macular degeneration (wAMD)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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