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

Overview

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.

Full Title of Study: “Intravitreal Bevacizumab for the Treatment of Patients With Low Vision Due to Neovascular Age-related Macular Degeneration”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2011

Detailed Description

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

Interventions

  • Drug: Bevacizumab
    • 1.25 mg intravitreal bevacizumab

Arms, Groups and Cohorts

  • Experimental: bevacizumab
    • three-monthly intravitreal bevacizumab, followed by PRN monthly injection on the basis of the detection of any fluid on the optical coherence tomography
  • No Intervention: control
    • monthly follow-up

Clinical Trial Outcome Measures

Primary Measures

  • change in best-corrected visual acuity
    • Time Frame: 6 months
    • change in best-corrected visual acuity at the end of the follow-up

Secondary Measures

  • change in central macular thickness
    • Time Frame: 6 months
    • change in central macular thickness on OCT
  • NEI VFQ-25 scores
    • Time Frame: 6 months
    • change in NEI VFQ-25 scores questionnaire

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • IRCCS San Raffaele
  • Provider of Information About this Clinical Study
    • Francesco Bandello, Department of Ophthalmology
  • Overall Official(s)
    • Francesco Bandello, MD, Study Chair, Department of Ophthalmology

References

Arevalo JF, Sánchez JG, Wu L, Berrocal MH, Alezzandrini AA, Restrepo N, Maia M, Farah ME, Brito M, Díaz-Llopis M, Rodríguez FJ, Reategui G, Iturralde-Iraola J, Udaondo-Mirete P; Pan-American Collaborative Retina Study Group. Intravitreal bevacizumab for subfoveal choroidal neovascularization in age-related macular degeneration at twenty-four months: the Pan-American Collaborative Retina Study. Ophthalmology. 2010 Oct;117(10):1974-81, 1981.e1. doi: 10.1016/j.ophtha.2010.01.056. Epub 2010 May 31.

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