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

This study has been completed.
Sponsor:
Information provided by:
IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT01327222
First received: March 30, 2011
Last updated: March 31, 2011
Last verified: January 2011
History of Changes

March 30, 2011
March 31, 2011
February 2011
February 2011   (final data collection date for primary outcome measure)
change in best-corrected visual acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
change in best-corrected visual acuity at the end of the follow-up
Same as current
Complete list of historical versions of study NCT01327222 on ClinicalTrials.gov Archive Site
  • change in central macular thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    change in central macular thickness on OCT
  • NEI VFQ-25 scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    change in NEI VFQ-25 scores questionnaire
Same as current
Not Provided
Not Provided
 
Intravitreal Bevacizumab for Low Vision in Neovascular Age-related Macular Degeneration (AMD)
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.

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Age Related Macular Degeneration
Drug: Bevacizumab
1.25 mg intravitreal bevacizumab
Other Name: avastin
  • 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
    Intervention: Drug: Bevacizumab
  • No Intervention: control
    monthly follow-up

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
55 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01327222
LOW-VISION
No
Francesco Bandello, Department of Ophthalmology
IRCCS San Raffaele
Not Provided
Study Chair: Francesco Bandello, MD Department of Ophthalmology
IRCCS San Raffaele
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP