Intravitreal Bevacizumab for Low Vision in Neovascular Age-related Macular Degeneration (AMD)
LOW-VISION
Intravitreal Bevacizumab for the Treatment of Patients With Low Vision Due to Neovascular Age-related Macular Degeneration
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 30, 2011
CompletedFirst Posted
Study publicly available on registry
April 1, 2011
CompletedApril 1, 2011
January 1, 2011
Same day
March 30, 2011
March 31, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in best-corrected visual acuity
change in best-corrected visual acuity at the end of the follow-up
6 months
Secondary Outcomes (2)
change in central macular thickness
6 months
NEI VFQ-25 scores
6 months
Study Arms (2)
bevacizumab
EXPERIMENTALthree-monthly intravitreal bevacizumab, followed by PRN monthly injection on the basis of the detection of any fluid on the optical coherence tomography
control
NO INTERVENTIONmonthly follow-up
Interventions
Eligibility Criteria
You may qualify if:
- age-related macular degeneration
- naïve subfoveal choroidal neovascularization
- best-corrected visual acuity less then 20/200
You may not qualify if:
- previous treatments
- any other condition able to limit the visual improvement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS San Raffaele
Milan, MI, 20132, Italy
Related Publications (2)
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.
PMID: 20569989BACKGROUNDParodi 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.
PMID: 22776937DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Francesco Bandello, MD
Department of Ophthalmology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 30, 2011
First Posted
April 1, 2011
Study Start
February 1, 2011
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
April 1, 2011
Record last verified: 2011-01