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

Ophthalmology, Macular Degeneration Clinical Trial

— AURA  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01447043
• Other study ID #: 15913
• Secondary ID: NN1101
• Status: Completed
• Phase: N/A
• First received: September 20, 2011
• Last updated: January 24, 2014
• Start date: January 2009
• Est. completion date: November 2012

Study information

• Verified date: January 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Board of Physicians (C.N.O.M "Comité National de l'Ordre des Médecins)Venezuela: Ethics CommitteeUK: UK Research Ethics Committee, UK National Health Service, Research and Development Department at each siteGermany: Ethics CommissionCanada: Ethics CommitteeIreland: Ethics CommitteeItaly: Ethics CommitteeNetherlands: n/a
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2609
• Est. completion date: November 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Macular Degeneration
• Ophthalmology, Macular Degeneration

Intervention

Drug:
• Ranibizumab
Patients with wet AMD treated with ranibizumab as prescribed by physician

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Australia,  Canada,  France,  Germany,  Ireland,  Italy,  Japan,  Netherlands,  United Kingdom,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Baseline and 24 months	No
Secondary	Demographic characteristics of patients included in the study (Age, Sex, Race)		Baseline	No
Secondary	Mean time from first clinical presentation to diagnosis		Time from first clinical presentation to diagnosis: Up to 36 months	No
Secondary	Mean time from diagnosis to treatment		Time from diagnosis to treatment: Up to 24 months	No
Secondary	Mean time from diagnosis to end of follow-up		Time from diagnosis to end of follow-up: 48 months	No
Secondary	Mean change of visual acuity, from diagnosis to end of follow-up, assessed by Early Treatment Diabetic Retinopathy (ETDRS) or SNELLEN		Baseline and 24 months	No
Secondary	Mean change of retinal thickness from diagnosis to end of follow-up, assessed by Optical Coherence Tomography (OCT)		Baseline and 24 months	No
Secondary	Mean change of lesion size from diagnosis to end of follow-up, assessed by Fluorescein Angiography (FA)		Baseline and 24 months	No
Secondary	Average number of treatments given from diagnosis to end of follow-up		After 24 months	No
Secondary	Vital Signs (blood pressure, heart rate, temperature) of patients included in the study		Baseline	No
Secondary	Medical and surgical history (diseases and surgeries) of patients included in the study		Baseline	No

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