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    IVAN data mined for insights on intravitreal anti-VEGF systemic safety

    Higher average serum VEGF associated with marginally increased risk of arterio-thrombotic events

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    Analyses of data from the Inhibition of VEGF in Age-related Choroidal Neovascularisation trial conducted to explore relationships between temporal changes in serum VEGF and safety events showed that at 1 year, a larger fall from baseline serum VEGF was associated with a lower hazard of death.

    Dr. Chakravarthy

    Belfast, Ireland—Determination of the systemic safety profiles of intravitreal anti-vascular endothelial growth factor (VEGF) therapy is an area of ongoing research.

    To that end, investigators from the Inhibition of VEGF in Age-related Choroidal Neovascularisation (IVAN) trial undertook analyses of data from their study to explore potential associations between serum VEGF and various safety outcomes.

    Usha Chakravarthy, MD, in looking at research for whether change in serum VEGF from baseline to month 12 or average serum VEGF—calculated as the mean of the baseline and month 12 values—predicted the frequency of:

    1. Arterio-thrombotic events (ATEs) and/or heart failure (events that have been associated with systemically administered anti-VEGF drugs);
    2. Other serious adverse events (SAEs) not previously associated with VEGF, or
    3. Gastrointestinal (GI) events.

    The analyses found that having a larger fall from baseline serum VEGF was associated with a lower hazard of death. In addition, higher average serum VEGF was associated with a marginally increased risk of ATEs. No other associations were found between decrease in serum VEGF or average serum VEGF and any of the safety endpoints analyzed.

    “Our findings offer fascinating insights into the mechanisms that underlie the systemic effects of these local therapies,” said Dr. Chakravarthy, lead investigator, IVAN trial, and professor of ophthalmology and vision sciences, The Queen’s University of Belfast, Northern Ireland.

    “Neutralizing VEGF cannot be good for the vasculature, and hence there is concern that anti-VEGF therapy may induce thrombogenesis,” Dr. Chakravarthy said. “However, too much VEGF in cancer patients is a marker for poor prognosis, and our finding associating larger falls in serum VEGF with a lower hazard of death is similar to the observation in cancer trials with bevacizumab where higher serum VEGF was associated with higher mortality.”

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