Review finds inconclusive data on off-label use of bevacizumab for ROP

Am J Ophthalmol. 2009;148(4):536-543.

Despite the potential for anti-VEGF therapy to disrupt the angiogenic phase of retinopathy of prematurity, published studies to date have not definitively defined the proper dose or timing of intravitreal injections.

According to a review of published studies on the use of Avastin (bevacizumab, Genentech) in treating ROP, "The lack of high-quality studies prevents any strong conclusions regarding the efficacy of bevacizumab for ROP, and therefore, physicians using it before further clinical trials are reported should proceed with caution and should ensure that patients are fully informed about its use."

After a systematic review, the study authors selected nine articles — six case reports, two retrospective studies and one prospective case series — representing 77 eyes of 48 patients. The authors noted that doses ranged from 0.4 mg to 1.25 mg in those studies, and while some studies examined bevacizumab monotherapy, others investigated the use of the anti-VEGF agent as an adjunct to retinal surgery.

Still, the authors said, "The beneficial effect and advantages of bevacizumab for ROP that have been reported in the limited literature to date indicate that the randomized control trials to come are warranted."