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

NCT ID: NCT01327222

Last Updated: 2011-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-02-28

Brief Summary

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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

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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

Conditions

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Age Related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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bevacizumab

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

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

1.25 mg intravitreal bevacizumab

control

monthly follow-up

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bevacizumab

1.25 mg intravitreal bevacizumab

Intervention Type DRUG

Other Intervention Names

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avastin

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Department of Ophthalmology

Principal Investigators

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Francesco Bandello, MD

Role: STUDY_CHAIR

Department of Ophthalmology

Locations

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IRCCS San Raffaele

Milan, MI, Italy

Site Status

Countries

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Italy

References

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Arevalo JF, Sanchez JG, Wu L, Berrocal MH, Alezzandrini AA, Restrepo N, Maia M, Farah ME, Brito M, Diaz-Llopis M, Rodriguez 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.

Reference Type BACKGROUND
PMID: 20569989 (View on PubMed)

Parodi MB, Cascavilla M, Papayannis A, Kontadakis DS, Bandello F, Iacono P. Intravitreal bevacizumab in advanced-stage neovascular age-related macular degeneration with visual acuity lower than 20/200. Arch Ophthalmol. 2012 Jul;130(7):934-5. doi: 10.1001/archophthalmol.2011.2617. No abstract available.

Reference Type DERIVED
PMID: 22776937 (View on PubMed)

Other Identifiers

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LOW-VISION

Identifier Type: -

Identifier Source: org_study_id

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