Intravitreal bevacizumab for retinopathy of prematurity: Considerations for informed consent.

Retinopathy of prematurity (ROP), a disease of abnormal blood vessel proliferation in the retina, is estimated to account for approximately 20% of cases of pediatric blindness worldwide. Guidelines set by the American Academy of Pediatrics, the American Academy of Ophthalmology, and the American Association for Pediatric Ophthalmology and Strabismus outline criteria for the screening and treatment of ROP. Laser photocoagulation and cryotherapy have long been available as treatment options; however, laser has essentially replaced cryotherapy as the standard of care. Although visual and structural outcomes are significantly better with laser treatment, a proportion of treated eyes still progress to unfavourable outcomes despite treatment. Treatment with laser results in irreversible destruction of the avascular retina, leading to permanent visual field deficits. Additionally, high incidence of strabismus and refractive errors after treatment remain an issue. Beginning in 2007, results of a newer treatment modality involving the use of anti-vascular endothelial growth factor (VEGF) agents have been published. In early case reports, there was extensive variability in the stage of disease treated and the use of anti-VEGF agents as first-line or salvage treatment and their use alone or in combination with other treatment modalities. A prospective randomized multicentre trial comparing laser treatment with anti-VEGF monotherapy was published in 2011 (BEAT-ROP [Bbevacizumab Eliminates the Angiogenic Threat of Retinopathy of Prematurity]). Based on results of this trial, the authors concluded that intravitreal bevacizumab (IVB) offered a significant benefit over laser for the treatment of stage 3þ ROP in zone I. Although some practitioners have expressed great enthusiasm, including endorsements that “intravitreal bevacizumab should become the treatment of choice for zone I retinopathy of prematurity,” others have expressed concern about the use of IVB in a neonatal population, the risk for systemic absorption, and the unknown long-term risks that may potentially be associated with their use. Additionally, there is controversy as to how to implement the use of IVB in ROP safely and how to conduct an informed consent process that is reflective of these safety concerns. In this editorial, we offer a framework for the consent process that may prove useful to ophthalmologists worldwide who treat ROP.