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Clinical Trials/NCT01327222
NCT01327222
Completed
Phase 3

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

IRCCS San Raffaele1 site in 1 country20 target enrollmentFebruary 2011

Overview

Phase
Phase 3
Intervention
Bevacizumab
Conditions
Age Related Macular Degeneration
Sponsor
IRCCS San Raffaele
Enrollment
20
Locations
1
Primary Endpoint
change in best-corrected visual acuity
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

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.

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

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
February 2011
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Arms & Interventions

bevacizumab

three-monthly intravitreal bevacizumab, followed by PRN monthly injection on the basis of the detection of any fluid on the optical coherence tomography

Intervention: Bevacizumab

Outcomes

Primary Outcomes

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

  • change in central macular thickness(6 months)
  • NEI VFQ-25 scores(6 months)

Study Sites (1)

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