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 Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 2,609
- Primary Endpoint
- 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
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group 1
Intervention: Ranibizumab (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Demographic characteristics of patients included in the study (Age, Sex, Race)(Baseline)
- Mean time from first clinical presentation to diagnosis(Time from first clinical presentation to diagnosis: Up to 36 months)
- Mean time from diagnosis to treatment(Time from diagnosis to treatment: Up to 24 months)
- Mean time from diagnosis to end of follow-up(Time from diagnosis to end of follow-up: 48 months)
- Medical and surgical history (diseases and surgeries) of patients included in the study(Baseline)
- Mean change of visual acuity, from diagnosis to end of follow-up, assessed by Early Treatment Diabetic Retinopathy (ETDRS) or SNELLEN(Baseline and 24 months)
- Vital Signs (blood pressure, heart rate, temperature) of patients included in the study(Baseline)
- Mean change of retinal thickness from diagnosis to end of follow-up, assessed by Optical Coherence Tomography (OCT)(Baseline and 24 months)
- Mean change of lesion size from diagnosis to end of follow-up, assessed by Fluorescein Angiography (FA)(Baseline and 24 months)
- Average number of treatments given from diagnosis to end of follow-up(After 24 months)