Clinical trial NCT01447043: Study to Assess the Effectiveness of Existing Anti vascUlar Endothelial Growth Factor (Anti VEGF) in Patients With Wet Age-related Macular Degeneration (wAMD) (AURA)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ophthalmology, Macular Degeneration
Keywords: retrospective studies
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-10-05
Enrollment: 2609
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients must have been diagnosed to suffer from wet AMD and must have started anti-VEGF treatment with ranibizumab between January 1, 2009, and August 31, 2009.

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Baseline and 24 months
Secondary outcomes:
measure: Demographic characteristics of patients included in the study (Age, Sex, Race)
timeFrame: Baseline
measure: Mean time from first clinical presentation to diagnosis
timeFrame: Time from first clinical presentation to diagnosis: Up to 36 months
measure: Mean time from diagnosis to treatment
timeFrame: Time from diagnosis to treatment: Up to 24 months
measure: Mean time from diagnosis to end of follow-up
timeFrame: Time from diagnosis to end of follow-up: 48 months
measure: Mean change of visual acuity, from diagnosis to end of follow-up, assessed by Early Treatment Diabetic Retinopathy (ETDRS) or SNELLEN
timeFrame: Baseline and 24 months
measure: Mean change of retinal thickness from diagnosis to end of follow-up, assessed by Optical Coherence Tomography (OCT)
timeFrame: Baseline and 24 months
measure: Mean change of lesion size from diagnosis to end of follow-up, assessed by Fluorescein Angiography (FA)
timeFrame: Baseline and 24 months
measure: Average number of treatments given from diagnosis to end of follow-up
timeFrame: After 24 months
measure: Vital Signs (blood pressure, heart rate, temperature) of patients included in the study
timeFrame: Baseline
measure: Medical and surgical history (diseases and surgeries) of patients included in the study
timeFrame: Baseline
Other outcomes:
Locations:
city: Many Locations
country: Australia
city: Many Locations
country: Canada
city: Many Locations
country: France
city: Many Locations
country: Germany
city: Many Locations
country: Ireland
city: Many Locations
country: Italy
city: Many Locations
country: Japan
city: Many Locations
country: Netherlands
city: Many Locations
country: United Kingdom
city: Many Locations
country: Venezuela
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Holz FG, Tadayoni R, Beatty S, Berger A, Cereda MG, Hykin P, Staurenghi G, Wittrup-Jensen K, Altemark A, Nilsson J, Kim K, Sivaprasad S. Key drivers of visual acuity gains in neovascular age-related macular degeneration in real life: findings from the AURA study. Br J Ophthalmol. 2016 Dec;100(12):1623-1628. doi: 10.1136/bjophthalmol-2015-308166. Epub 2016 Mar 30.
citation: Holz FG, Tadayoni R, Beatty S, Berger A, Cereda MG, Cortez R, Hoyng CB, Hykin P, Staurenghi G, Heldner S, Bogumil T, Heah T, Sivaprasad S. Multi-country real-life experience of anti-vascular endothelial growth factor therapy for wet age-related macular degeneration. Br J Ophthalmol. 2015 Feb;99(2):220-6. doi: 10.1136/bjophthalmol-2014-305327. Epub 2014 Sep 5.