NEW YORK (Reuters Health) – Babies with acute-phase retinopathy of prematurity (ROP) who are treated with bevacizumab have more long-term eye problems than babies treated with laser, according to a new randomized controlled trial done in Italy.
“Our paper demonstrates long-term ocular effects from using an anti-VEGF (anti-vascular endothelial growth factor) drug such as bevacizumab for the treatment of acute-phase ROP. These effects, including abnormalities of the posterior pole and peripheral retina, are seen much more frequently than they are in laser-treated eyes,” said coauthor Dr. Graham E. Quinn of the University of Pennsylvania Perelman School of Medicine, in Philadelphia.
“The longer-term effects of these structural changes on function have yet to be examined. It is important to provide visual acuity, visual field, and refractive error data, as well as assessment of late detachment and retinal tears, in eyes treated with anti-VEGF,” he told Reuters Health by email.
“Many of these findings are worrisome,” the authors write in their report, published online September 1 in Ophthalmology. “It is incumbent on the medical community caring for the premature infant to determine the optimum treatment regimen for serious ROP, not only from an ocular perspective but also from a systemic perspective.”
Dr. Quinn and his colleagues studied the structural outcomes, at age 4 years, for all 21 babies born in their clinic (42 eyes) who had type 1 zone 1 ROP and were treated in the neonatal intensive care unit over roughly 2.5 years.
For each infant, they took digital retinal images and performed fluorescein angiography (FA). They randomized one eye to have conventional laser photoablation of the peripheral avascular retina and the fellow eye to have 0.5 mg bevacizumab in a 0.02-mL balanced salt solution injected intravitreally through the pars plicata.
The babies’ eyes were examined regularly for one year, and they had fluorescein angiography when they were an average of 4 years old. All 20 available 4-year-old bevacizumab-treated eyes showed abnormalities at the periphery – including avascularity, shunts, vessel leakage, abnormal vessel branching and tangles – or at the posterior pole, including hyperfluorescent lesions and foveal avascular zone absence.
These lesions were not seen in most of the laser-treated eyes. Among the 19 lasered eyes, the authors found leakage in one eye, shunts and tangles in three eyes, and macular abnormalities in three.
The authors acknowledge that the within-subject randomization may have made it less likely to find differences between fellow eyes due to intravitreal bevacizumab leakage from the eye into the systemic circulation; that the prevalence of abnormalities may be related to the bevacizumab dose; and that masking was impossible.
Dr. Mary Elizabeth Hartnett of the University of Utah in Salt Lake City, who was not involved in the study, told Reuters Health by email, “The study is important because it provides information on fluorescein angiographic characteristics after bevacizumab in ROP, and there are few reports on this. The study provides important information on ongoing vascularization of the peripheral avascular retina to a certain degree and persistent avascular retina in the macula and peripheral retina following intravitreal bevacizumab for type 1 ROP. As the investigators acknowledge, reduced dose is important to study.”
“There is concern in the pediatric retina community that persistent avascular retina following treatment with anti-VEGF may make the retina vulnerable to later retinal tears and detachments, which also threaten vision at an older age,” said Dr. Hartnett, who was not involved in the study. “Many are advocating a study to test the role of laser once infants have progressed beyond the equator in zone 2.”
Dr. Quinn added, “Ideally, further research would include adequately sized trials with adequate long-term follow-up to determine ocular and systemic adverse effects.”
“We in medicine have learned hard lessons adopting oxygen treatment in premature infants without realizing the implications of its unrestricted use,” he recommended.
SOURCE: http://bit.ly/2eZk2Zk
Ophthalmology 2017.
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