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)

January 24, 2014 updated by: Bayer

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2609

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Ranibizumab
Patients with wet AMD treated with ranibizumab as prescribed by physician

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Baseline and 24 months
Baseline and 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Demographic characteristics of patients included in the study (Age, Sex, Race)
Time Frame: Baseline
Baseline
Mean time from diagnosis to treatment
Time Frame: Time from diagnosis to treatment: Up to 24 months
Time from diagnosis to treatment: Up to 24 months
Mean change of retinal thickness from diagnosis to end of follow-up, assessed by Optical Coherence Tomography (OCT)
Time Frame: Baseline and 24 months
Baseline and 24 months
Mean change of lesion size from diagnosis to end of follow-up, assessed by Fluorescein Angiography (FA)
Time Frame: Baseline and 24 months
Baseline and 24 months
Average number of treatments given from diagnosis to end of follow-up
Time Frame: After 24 months
After 24 months
Mean time from first clinical presentation to diagnosis
Time Frame: Time from first clinical presentation to diagnosis: Up to 36 months
Time from first clinical presentation to diagnosis: Up to 36 months
Mean time from diagnosis to end of follow-up
Time Frame: Time from diagnosis to end of follow-up: 48 months
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 SNELLEN
Time Frame: Baseline and 24 months
Baseline and 24 months
Vital Signs (blood pressure, heart rate, temperature) of patients included in the study
Time Frame: Baseline
Baseline
Medical and surgical history (diseases and surgeries) of patients included in the study
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

September 20, 2011

First Submitted That Met QC Criteria

October 4, 2011

First Posted (ESTIMATE)

October 5, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 27, 2014

Last Update Submitted That Met QC Criteria

January 24, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15913
  • NN1101 (OTHER: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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