Trial Condition(s):
Ophthalmology, Macular Degeneration
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)
Bayer Identifier:
15913
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Germany | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, United Kingdom | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, France | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Japan | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Italy | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Australia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Venezuela | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Ireland | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Canada | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Netherlands | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
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 chardTimeframe: Baseline and 24 months
Secondary Outcome
- Demographic characteristics of patients included in the study (Age, Sex, Race)Timeframe: Baseline
- Mean time from first clinical presentation to diagnosisTimeframe: Time from first clinical presentation to diagnosis: Up to 36 months
- Mean time from diagnosis to treatmentTimeframe: Time from diagnosis to treatment: Up to 24 months
- Mean time from diagnosis to end of follow-upTimeframe: 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 SNELLENTimeframe: Baseline and 24 months
- Mean change of retinal thickness from diagnosis to end of follow-up, assessed by Optical Coherence Tomography (OCT)Timeframe: Baseline and 24 months
- Mean change of lesion size from diagnosis to end of follow-up, assessed by Fluorescein Angiography (FA)Timeframe: Baseline and 24 months
- Average number of treatments given from diagnosis to end of follow-upTimeframe: After 24 months
- Vital Signs (blood pressure, heart rate, temperature) of patients included in the studyTimeframe: Baseline
- Medical and surgical history (diseases and surgeries) of patients included in the studyTimeframe: Baseline
Additional Information
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