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Renata Portella Nunes, Eduardo B. Rodrigues, Rubens Belfort, Jr., Flavio E. Hirai, Octaviano Magalhaes, Jr., Huang S. Jiun, Fernando M. Penha, Mauricio Maia, Michel E. Farah; A Study On The Cost-effectiveness Of The Anti-VEGF Treatments For Age-related Macular Degeneration. Invest. Ophthalmol. Vis. Sci. 2011;52(14):112.
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To study the efficacy and cost-effectiveness of therapy with intravitreal ranibizumab (IVR) and bevacizumab (IVB) in exudative age-related macular degeneration (AMD).
The study is composed by a systematic review of the literature and a prospective randomized clinical trial (RCT) comparing the efficacy of IVR and IVB as therapy for wet-AMD. The systematic review was performed matching terms related to the topic in Pubmed and EMBASE. We used the U.S. Preventive Services Task Force to classify the level of evidence. References with levels of evidence I and II-1 were selected. For the RCT, forty-five patients with exudative-AMD are being randomized (1:1:1) in three groups: monthly 0.5mg IVR, monthly 1.25mg IVB, and every-two-weeks 1.25mg IVB. All patients received three months loading dose and then are followed with as-needed regimen. ETDRS best-corrected visual acuity, spectral domain optic coherence tomography (Spectralis, Heidelberg Engineering Inc., Heidelberg, Germany), fluorescein angiography HRA2 (Heidelberg Engineering Inc., Heidelberg, Germany) and microperimetry (MAIA, Padova, Italy) examinations are being performed. Patients will be followed for one year.
A total of 1312 references regarding IVR and/or IVB for wet-AMD were found on the systematic review. Fifteen prospective RCT, eight level I and seven level II-1 of evidence, were selected. Seven prospective clinical trials referred to Bevacizumab, six clinical trials on Ranibizumab and two comparative clinical trials with both drugs. Safety data showed no cause-effect relation with both drugs and serious adverse effects. There was a low rate of either ocular or systemic adverse effects, as stroke and myocardial infarction, reported with both drugs. Systematic review also showed that similar vision improvement has been achieved with both ranibizumab and bevacizumab (average visual improvement of 5,8 and 7,9 letters respectively). The clinical trial started recruiting in June 2010 and results should be available in early 2012. Important design issues for this clinical trial include use of cost-effectiveness as outcome and use of 3 months loading dose and re-treatments as necessary rather than continuous therapy.
The efficacy and safety of bevacizumab may be comparable to ranibizumab in the therapy of exudative AMD.
Clinical Trial: :
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