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

Primary Purpose

Age Related Macular Degeneration

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Bevacizumab
Sponsored by
IRCCS San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring age-related macular degeneration, bevacizumab

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IRCCS San Raffaele

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

bevacizumab

control

Arm Description

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

monthly follow-up

Outcomes

Primary Outcome Measures

change in best-corrected visual acuity
change in best-corrected visual acuity at the end of the follow-up

Secondary Outcome Measures

change in central macular thickness
change in central macular thickness on OCT
NEI VFQ-25 scores
change in NEI VFQ-25 scores questionnaire

Full Information

First Posted
March 30, 2011
Last Updated
March 31, 2011
Sponsor
IRCCS San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT01327222
Brief Title
Intravitreal Bevacizumab for Low Vision in Neovascular Age-related Macular Degeneration (AMD)
Acronym
LOW-VISION
Official Title
Intravitreal Bevacizumab for the Treatment of Patients With Low Vision Due to Neovascular Age-related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
IRCCS San Raffaele

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
age-related macular degeneration, bevacizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bevacizumab
Arm Type
Experimental
Arm Description
three-monthly intravitreal bevacizumab, followed by PRN monthly injection on the basis of the detection of any fluid on the optical coherence tomography
Arm Title
control
Arm Type
No Intervention
Arm Description
monthly follow-up
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
avastin
Intervention Description
1.25 mg intravitreal bevacizumab
Primary Outcome Measure Information:
Title
change in best-corrected visual acuity
Description
change in best-corrected visual acuity at the end of the follow-up
Time Frame
6 months
Secondary Outcome Measure Information:
Title
change in central macular thickness
Description
change in central macular thickness on OCT
Time Frame
6 months
Title
NEI VFQ-25 scores
Description
change in NEI VFQ-25 scores questionnaire
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Bandello, MD
Organizational Affiliation
Department of Ophthalmology
Official's Role
Study Chair
Facility Information:
Facility Name
IRCCS San Raffaele
City
Milano
State/Province
MI
ZIP/Postal Code
20132
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
20569989
Citation
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.
Results Reference
background
PubMed Identifier
22776937
Citation
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.
Results Reference
derived

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

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