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Completed

NCT Number: NCT01933152

Study to Assess the EffectiVeness of exIsting Anti-vascular Endothelial groWth Factor (Anti-VEGF) Treatment Regimens in Patients With Wet Age-related Macular Degeneration

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 December 31, 2009 must be consecutively screened and, if eligible, enrolled. Patients will be followed up at maximum until December 31, 2011. Switch to any other Anti vascular endothelial growth factor (anti VEGF) treatment will be documented. 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

Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Portugal

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-VEGF therapy with ranibizumab (Lucentis) between January 1, 2009 and December 31, 2009
  • Informed consent form signed

Exclusion criteria

  • Participation in an investigational study during anti-VEGF therapy (from start up to December 31, 2011) that involved treatment with any drug or 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: Baseline

  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: up to 48 months

  5. Mean change of visual acuity, from diagnosis to end of follow-up, assessed by Early Treatment Diabetic Retinopathy (ETDRS) or Snellen chart

    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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Review Study: A Retrospective Noninterventional Study to Assess the EffectiVeness of exIsting Anti-vascular Endothelial groWth Factor (Anti-VEGF) Treatment Regimens in Patients With Wet Age-related Macular Degeneration

Acronym: REVIEW

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 2, 2013
Registry last updated
Oct 1, 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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