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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01447043




Registration number
NCT01447043
Ethics application status
Date submitted
20/09/2011
Date registered
5/10/2011
Date last updated
27/01/2014

Titles & IDs
Public title
Study to Assess the Effectiveness of Existing Anti vascUlar Endothelial Growth Factor (Anti VEGF) in Patients With Wet Age-related Macular Degeneration (wAMD) (AURA)
Scientific 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)
Secondary ID [1] 0 0
NN1101
Secondary ID [2] 0 0
15913
Universal Trial Number (UTN)
Trial acronym
AURA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ophthalmology, Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Ranibizumab

Group 1 -


Treatment: Drugs: Ranibizumab
Patients with wet AMD treated with ranibizumab as prescribed by physician
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline and 24 months
Secondary outcome [1] 0 0
Demographic characteristics of patients included in the study (Age, Sex, Race)
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
Mean time from first clinical presentation to diagnosis
Timepoint [2] 0 0
Time from first clinical presentation to diagnosis: Up to 36 months
Secondary outcome [3] 0 0
Mean time from diagnosis to treatment
Timepoint [3] 0 0
Time from diagnosis to treatment: Up to 24 months
Secondary outcome [4] 0 0
Mean time from diagnosis to end of follow-up
Timepoint [4] 0 0
Time from diagnosis to end of follow-up: 48 months
Secondary outcome [5] 0 0
Mean change of visual acuity, from diagnosis to end of follow-up, assessed by Early Treatment Diabetic Retinopathy (ETDRS) or SNELLEN
Timepoint [5] 0 0
Baseline and 24 months
Secondary outcome [6] 0 0
Mean change of retinal thickness from diagnosis to end of follow-up, assessed by Optical Coherence Tomography (OCT)
Timepoint [6] 0 0
Baseline and 24 months
Secondary outcome [7] 0 0
Mean change of lesion size from diagnosis to end of follow-up, assessed by Fluorescein Angiography (FA)
Timepoint [7] 0 0
Baseline and 24 months
Secondary outcome [8] 0 0
Average number of treatments given from diagnosis to end of follow-up
Timepoint [8] 0 0
After 24 months
Secondary outcome [9] 0 0
Vital Signs (blood pressure, heart rate, temperature) of patients included in the study
Timepoint [9] 0 0
Baseline
Secondary outcome [10] 0 0
Medical and surgical history (diseases and surgeries) of patients included in the study
Timepoint [10] 0 0
Baseline

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2012
Sample size
Target
Accrual to date
Final
2609
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Many Locations
Recruitment postcode(s) [1] 0 0
- Many Locations
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Many Locations
Country [2] 0 0
France
State/province [2] 0 0
Many Locations
Country [3] 0 0
Germany
State/province [3] 0 0
Many Locations
Country [4] 0 0
Ireland
State/province [4] 0 0
Many Locations
Country [5] 0 0
Italy
State/province [5] 0 0
Many Locations
Country [6] 0 0
Japan
State/province [6] 0 0
Many Locations
Country [7] 0 0
Netherlands
State/province [7] 0 0
Many Locations
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Many Locations
Country [9] 0 0
Venezuela
State/province [9] 0 0
Many Locations

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01447043
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01447043