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    Ethics involved in using anti-VEGFs for pediatric patients

    Informed consent for this off-label treatment needs to involve more than a simple signature

    Chicago—Although new technologies and treatments are emerging for retinopathy of prematurity (ROP), there are certain ethical consideration for their use, said R.V. Paul Chan, MD, Illinois Eye and Ear Infirmary, University of Illinois at Chicago and member of the American Academy of Ophthalmology’s Ethics Committee.

    “Adequate informed consent, adequate pre-treatment assessment, and appropriate postop care in the use of anti-VEGF treatments are required in order to comply with the Code of Ethics,” Dr. Chan said.

    Related: Genetic mutation findings in Spanish retinitis pigmentosa

    When discussing treatment options for ROP, it is imperative not to discount the role of informed consent, he said.

    “This is extremely important, especially for anti-vascular endothelial growth factor (VEGF) treatment,” he said. “Do the parents understand what you’re talking about? There’s a trend these days to think that injections may not need all the descriptives about the risks, benefits, and alternatives.” As it turns out, that is not the case—in fact, it is not enough to only have the parent sign a piece of paper.

    Case example

    “Signed documents do not mean you’ve given a good informed consent,” he said.

    For example, he cited a hypothetical case with a pediatric ophthalmologist in a major metropolitan area who is responsible for teaching residents, fellows, and medical students, and who oversees ROP care throughout his metropolitan area. A baby with active ROP presents having failed conventional therapy with laser and has progressing disease.

    Related: Digital imaging screening may identify infants with referral-warranted ROP

    “We now have the option of injecting with anti-vascular endothelial growth factor (VEGF) treatment,” Dr. Chan said. In this case, the physician, Dr. A, plans to use intravitreal bevacizumab off-label to treat the patient’s progressing ROP.

    “Dr. A tells the parents the only hope for their child is intravitreal injection and that the treatment can be considered standard of care because of all the studies that have been published on its use,” Dr. Chan said.

    Related: Consider PDGF treatment prior to anti-VEGF therapy

    Herein lies the dilemma, he said—the parents inherently trust the physician and will likely follow the advice.

    A better approach

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