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S. G. Baarsma, I. L. van den Born, J. P. Martinez-Ciriano, T. Missotten; Safety and Intra-Ocular Anti-VEGF Injections: Observations in a Bevacizumab Cohort. Invest. Ophthalmol. Vis. Sci. 2009;50(13):3097.
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Ocular and systemic safety of intraocular BevacizumabTM injections was studied in a cohort of 718 patients and compared to epidemiological data on cerebrovascular accidents (CVA), myocardial infarction (MCI) and mortality.
In a cohort of 718 patients (2648 injections), ocular and systemic safety was monitored from March-2006 till March-2008. The Dutch WHO and Epidemiological Rotterdam Study mortality, CVA and MCI data were used to create an age-matched group which provided expected incidences of CVA, MCI and mortality.
Ocular adverse events included 1 endophthalmitis (0.038%), 7 uveitic responses (0.264%), and 11 RIPs (0.415%). Systemic problems included 10 cases of CVA (1.416% per patient year (pPY), 14 cases of MCI (1.981% pPY). 10 patients died during follow-up (1.416% pPY). No significant different incidences with epidemiological data were found for CVA (expected 7.4 : observed 10, p=0.465) and MCI ( expected 11: observed 14, p=0.55). In this cohort 10 patients died compared to the 38 expected mortalities p=3.8x10e-5. Analysis showed this group could determine safety for risk ratios of about 2.50x in MCI/CVA
This study confirms earlier reports regarding the ocular and systemic safety of anti-VEGF intravitreal injections. As large placebo-controlled studies are not ethically possible, observed adverse event incidence should be compared with well-defined (age, gender, race) data of epidemiologic studies. In order to study small risk increases for MCI and CVA in the order of 1.25x-1.50x, data in groups larger than 10.000 patients using intra-ocular anti-VEGF therapy are required.
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