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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)

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ClinicalTrials.gov Identifier: NCT01447043
Recruitment Status : Completed
First Posted : October 5, 2011
Last Update Posted : January 27, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment
Ophthalmology, Macular Degeneration Drug: Ranibizumab

Study Type : Observational
Actual Enrollment : 2609 participants
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)
Study Start Date : January 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01447043     History of Changes
Other Study ID Numbers: 15913
NN1101 ( Other Identifier: company internal )
First Posted: October 5, 2011    Key Record Dates
Last Update Posted: January 27, 2014
Last Verified: January 2014

Keywords provided by Bayer:
retrospective studies

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Bevacizumab
Endothelial Growth Factors
Mitogens
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action