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

Phase 3

Completed

• Conditions: Age Related Macular Degeneration
• Interventions: Drug: Bevacizumab

• Registration Number: NCT01327222
• Lead Sponsor: IRCCS San Raffaele

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

Study Timeline

• Status Verified: 2011-01
• Study Start: 2011-02
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Study First Submitted: 2011-03-30
• Study First Submitted QC: 2011-03-31
• Last Update Submitted: 2011-03-31
• Study First Posted: 2011-04-01
• Last Update Posted: 2011-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
change in best-corrected visual acuity	6 months	change in best-corrected visual acuity at the end of the follow-up

Secondary Outcome Measures

Name	Time	Method
change in central macular thickness	6 months	change in central macular thickness on OCT
NEI VFQ-25 scores	6 months	change in NEI VFQ-25 scores questionnaire

Trial Locations

Locations (1)

IRCCS San Raffaele; 🇮🇹 Milano, MI, Italy