Trial Review

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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01447043