Study to Assess the Effectiveness of Existing Anti vascUlar Endothelial Growth Factor (Anti VEGF) in Patients With Wet Age-related Macular Degeneration (wAMD) (AURA)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group 1
|
Drug: Ranibizumab
Patients with wet AMD treated with ranibizumab as prescribed by physician
|
Outcome Measures
Primary Outcome 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 [Baseline and 24 months]
Secondary Outcome Measures
- 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]
- 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]
- 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]
- Vital Signs (blood pressure, heart rate, temperature) of patients included in the study [Baseline]
- Medical and surgical history (diseases and surgeries) of patients included in the study [Baseline]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Many Locations | Australia | |||
| 2 | Many Locations | Canada | |||
| 3 | Many Locations | France | |||
| 4 | Many Locations | Germany | |||
| 5 | Many Locations | Ireland | |||
| 6 | Many Locations | Italy | |||
| 7 | Many Locations | Japan | |||
| 8 | Many Locations | Netherlands | |||
| 9 | Many Locations | United Kingdom | |||
| 10 | Many Locations | Venezuela |
Sponsors and Collaborators
- Bayer
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15913
- NN1101