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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01447043
First received: September 20, 2011
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Ophthalmology, Macular Degeneration
Drug: Ranibizumab

Study Type: Observational
Study Design: Time Perspective: Retrospective
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)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Demographic characteristics of patients included in the study (Age, Sex, Race) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Mean time from first clinical presentation to diagnosis [ Time Frame: Time from first clinical presentation to diagnosis: Up to 36 months ] [ Designated as safety issue: No ]
  • Mean time from diagnosis to treatment [ Time Frame: Time from diagnosis to treatment: Up to 24 months ] [ Designated as safety issue: No ]
  • Mean time from diagnosis to end of follow-up [ Time Frame: Time from diagnosis to end of follow-up: 48 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Mean change of retinal thickness from diagnosis to end of follow-up, assessed by Optical Coherence Tomography (OCT) [ Time Frame: Baseline and 24 months ] [ Designated as safety issue: No ]
  • Mean change of lesion size from diagnosis to end of follow-up, assessed by Fluorescein Angiography (FA) [ Time Frame: Baseline and 24 months ] [ Designated as safety issue: No ]
  • Average number of treatments given from diagnosis to end of follow-up [ Time Frame: After 24 months ] [ Designated as safety issue: No ]
  • Vital Signs (blood pressure, heart rate, temperature) of patients included in the study [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Medical and surgical history (diseases and surgeries) of patients included in the study [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 2609
Study Start Date: January 2009
Study Completion Date: November 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Ranibizumab
Patients with wet AMD treated with ranibizumab as prescribed by physician

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447043

Locations
Australia
Many Locations, Australia
Canada
Many Locations, Canada
France
Many Locations, France
Germany
Many Locations, Germany
Ireland
Many Locations, Ireland
Italy
Many Locations, Italy
Japan
Many Locations, Japan
Netherlands
Many Locations, Netherlands
United Kingdom
Many Locations, United Kingdom
Venezuela
Many Locations, Venezuela
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01447043     History of Changes
Other Study ID Numbers: 15913, NN1101
Study First Received: September 20, 2011
Last Updated: January 24, 2014
Health Authority: France: National Board of Physicians (C.N.O.M "Comité National de l'Ordre des Médecins)
Venezuela: Ethics Committee
UK: UK Research Ethics Committee, UK National Health Service, Research and Development Department at each site
Germany: Ethics Commission
Canada: Ethics Committee
Ireland: Ethics Committee
Italy: Ethics Committee
Netherlands: n/a

Keywords provided by Bayer:
retrospective studies

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Mitogens
Endothelial Growth Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014