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Completed

NCT Number: NCT01327222

Intravitreal Bevacizumab for Low Vision in Neovascular Age-related Macular Degeneration (AMD)

The purpose of this study is to compare the effectiveness of intravitreal bevacizumab injection (IVBI) with respect to simple observation in patients with subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD) presenting at baseline with best corrected visual acuity (BCVA) less than 20/200.

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Key information

Conditions

Age Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

IRCCS San Raffaele

Milan, MI, 20132, Italy

About this study

There is no clear indication regarding the treatment of patients with subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD) presenting at baseline with best corrected visual acuity (BCVA) less than 20/200.

Treatment of eyes with low visual acuity could lead to a waste of resources, without any functional and social improvements.

Aim of the present study is to compare the effectiveness of intravitreal bevacizumab injection (IVBI) with respect to simple observation in

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age-related macular degeneration
  • naïve subfoveal choroidal neovascularization
  • best-corrected visual acuity less then 20/200

Exclusion criteria

  • previous treatments
  • any other condition able to limit the visual improvement

Treatment and study plan

Bevacizumab

Drug

1.25 mg intravitreal bevacizumab

Other names: avastin

Primary outcomes

  1. change in best-corrected visual acuity

    Time frame: 6 months

    change in best-corrected visual acuity at the end of the follow-up

Secondary outcomes

  1. change in central macular thickness

    Time frame: 6 months

    change in central macular thickness on OCT

  2. NEI VFQ-25 scores

    Time frame: 6 months

    change in NEI VFQ-25 scores questionnaire

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

Intravitreal Bevacizumab for the Treatment of Patients With Low Vision Due to Neovascular Age-related Macular Degeneration

Acronym: LOW-VISION

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 1, 2011
Registry last updated
Apr 1, 2011

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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