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:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01447043
First received: September 20, 2011
Last updated: January 15, 2013
Last verified: January 2013
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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:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
Drug Information available for:
Ranibizumab
U.S. FDA Resources
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
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: | Global Medical Affairs Therapeutic Area Head, Bayer HealthCare AG |
| ClinicalTrials.gov Identifier: | NCT01447043 History of Changes |
| Other Study ID Numbers: | 15913, NN1101 |
| Study First Received: | September 20, 2011 |
| Last Updated: | January 15, 2013 |
| 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 May 22, 2013