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Usha Chakravarthy, Chris Rogers, Barney Reeves, Lauren Scott, Simon P Harding, Susan M Downes, Andrew Lotery, IVAN study Group; Alterations in serum vascular endothelial growth factor after intraocular administration of antiVEGF drugs, is there an association with safety outcomes?. Invest. Ophthalmol. Vis. Sci. 2014;55(13):871.
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To investigate whether the fall in serum vascular endothelial growth factor (VEGF) levels after intraocular administration of anti VEGF drugs in the “alternative treatments to Inhibit VEGF in Age-related choroidal Neovascularisation (IVAN) clinical trial, is related to safety outcomes.
IVAN participants were seen monthly for 2-years. VEGF levels were measured in serum samples taken at visits 0, 1, 11, 12, 23 and 24. We compared the change in VEGF levels from visit 0 to visits 1, 12 and 24 by drug and treatment regimen and examined the relationship between the change in VEGF levels after one treatment (i.e. between visits 0 and 1) and the subsequent occurrence of a serious adverse event (SAE) not previously known to be associated with anti-VEGF therapy (i.e. we excluded cardiovascular-related SAEs). Analyses were adjusted for patient demography and past history.
Data on VEGF levels were available for 506 IVAN participants. VEGF levels declined over time in all groups, but the decline was greater with bevacizumab than ranibizumab (see Figure). No statistically significant associations were detected between SAE occurrence and the change in VEGF level (p=0.92) or the amount of circulating VEGF (p=0.95). Similarly no association with drug or treatment frequency was found (p=0.80 and p=0.29 respectively).
These preliminary analyses found no association between the occurrence of an SAE and circulating VEGF levels. Work is ongoing to further classify SAEs into those that could and could not plausibly be influenced by VEGF levels, in order to examine whether an association exists for this subgroup of events.
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