Study to Assess the Effectiveness of Existing Anti vascUlar Endothelial Growth Factor (Anti VEGF) in Patients With Wet Age-related Macular Degeneration (wAMD) (AURA)

NCT ID: NCT01447043

Last Updated: 2014-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2609 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ophthalmology, Macular Degeneration

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1

Ranibizumab

Intervention Type DRUG

Patients with wet AMD treated with ranibizumab as prescribed by physician

Interventions

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Ranibizumab

Patients with wet AMD treated with ranibizumab as prescribed by physician

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Australia

Site Status

Many Locations, , Canada

Site Status

Many Locations, , France

Site Status

Many Locations, , Germany

Site Status

Many Locations, , Ireland

Site Status

Many Locations, , Italy

Site Status

Many Locations, , Japan

Site Status

Many Locations, , Netherlands

Site Status

Many Locations, , United Kingdom

Site Status

Many Locations, , Venezuela

Site Status

Countries

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Australia Canada France Germany Ireland Italy Japan Netherlands United Kingdom Venezuela

References

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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.

Reference Type DERIVED
PMID: 27030279 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25193672 (View on PubMed)

Other Identifiers

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NN1101

Identifier Type: OTHER

Identifier Source: secondary_id

15913

Identifier Type: -

Identifier Source: org_study_id

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