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

March 31, 2011 updated by: IRCCS San Raffaele

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Milano, MI, Italy, 20132
        • IRCCS San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Bevacizumab
1.25 mg intravitreal bevacizumab
Other Names:
  • avastin
No Intervention: control
monthly follow-up

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Study Chair: Francesco Bandello, MD, Department of Ophthalmology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

March 30, 2011

First Submitted That Met QC Criteria

March 31, 2011

First Posted (Estimate)

April 1, 2011

Study Record Updates

Last Update Posted (Estimate)

April 1, 2011

Last Update Submitted That Met QC Criteria

March 31, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOW-VISION

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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