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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bevacizumab | Experimental | three-monthly intravitreal bevacizumab, followed by PRN monthly injection on the basis of the detection of any fluid on the optical coherence tomography |
|
| control | No Intervention | monthly follow-up |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | 1.25 mg intravitreal bevacizumab |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| change in best-corrected visual acuity | change in best-corrected visual acuity at the end of the follow-up | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in central macular thickness | change in central macular thickness on OCT | 6 months |
| NEI VFQ-25 scores | change in NEI VFQ-25 scores questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Bandello, MD | Department of Ophthalmology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele | Milan | MI | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20569989 | Background | 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. | |
| 22776937 |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 6 months |
| Derived |
| 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. |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |