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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 January 2013 |
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Main ID: |
NCT01447043 |
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Date of registration:
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20/09/2011 |
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Primary sponsor: |
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Public title:
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Study to Assess the Effectiveness of Existing Anti vascUlar Endothelial Growth Factor (Anti VEGF) in Patients With Wet Age-related Macular Degeneration (wAMD) (AURA)
AURA |
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Scientific title:
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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) |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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2609 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01447043 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Retrospective
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Countries of recruitment
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Australia
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Canada
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France
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Germany
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Ireland
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Italy
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Japan
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Netherlands
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United Kingdom
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Venezuela
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Contacts
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Name:
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Bayer Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bayer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ophthalmology, Macular Degeneration
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Intervention(s)
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Drug: Ranibizumab
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Average number of treatments given from diagnosis to end of follow-up
[Time Frame: After 24 months]
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Demographic characteristics of patients included in the study (Age, Sex, Race)
[Time Frame: Baseline]
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Mean change of lesion size from diagnosis to end of follow-up, assessed by Fluorescein Angiography (FA)
[Time Frame: Baseline and 24 months]
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Mean change of retinal thickness from diagnosis to end of follow-up, assessed by Optical Coherence Tomography (OCT)
[Time Frame: Baseline and 24 months]
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Mean change of visual acuity, from diagnosis to end of follow-up, assessed by Early Treatment Diabetic Retinopathy (ETDRS) or SNELLEN
[Time Frame: Baseline and 24 months]
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Mean time from diagnosis to end of follow-up
[Time Frame: Time from diagnosis to end of follow-up: 48 months]
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Mean time from diagnosis to treatment
[Time Frame: Time from diagnosis to treatment: Up to 24 months]
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Mean time from first clinical presentation to diagnosis
[Time Frame: Time from first clinical presentation to diagnosis: Up to 36 months]
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Medical and surgical history (diseases and surgeries) of patients included in the study
[Time Frame: Baseline]
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Vital Signs (blood pressure, heart rate, temperature) of patients included in the study
[Time Frame: Baseline]
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Secondary ID(s)
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15913
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NN1101
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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