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Completed

NCT Number: NCT01447043

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

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.

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Key information

Conditions

Ophthalmology, Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Drug

Patients with wet AMD treated with ranibizumab as prescribed by physician

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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)

Acronym: AURA

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Oct 5, 2011
Registry last updated
Jan 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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