Ranibizumab Plus Dexamethasone vs. Ranibizumab Alone in DME
HealthDay News — The addition of intravitreous dexamethasone to continued ranibizumab therapy does not improve visual acuity in eyes with persistent diabetic macular edema (DME) after anti-vascular endothelial growth factor (anti-VEGF) therapy, according to a study published online November 11 in JAMA Ophthalmology to coincide with the annual meeting of the American Academy of Ophthalmology, being held November 11 to 14 in New Orleans.
Raj K. Maturi, MD, from the Midwest Eye Institute in Indianapolis, and colleagues randomized 129 eyes with persistent DME from 116 adults with diabetes to receive 700 µg of dexamethasone (combination group; 65 eyes) or sham treatment (ranibizumab group; 64 eyes) in addition to continued 0.3-mg ranibizumab.
The researchers found that the mean improvement in visual acuity from randomization was 2.7 and 3 letters in the combination and ranibizumab groups, with the adjusted treatment group difference of −0.5 letters (95% confidence interval, −3.6 to 2.5; two-sided P=0.73). The mean change in central subfield thickness was −110 and −62 µm for the combination and ranibizumab groups, respectively (adjusted difference, −52; 95% confidence interval, −82 to −22; two-sided P<0.001). Nineteen eyes and no eyes in the combination and ranibizumab groups, respectively, experienced increased intraocular pressure or initiated treatment with antihypertensive eye drops (two-sided P<0.001).
"Although its use is more likely to reduce retinal thickness and increase intraocular pressure, the addition of intravitreous dexamethasone to continued ranibizumab therapy does not improve visual acuity at 24 weeks more than continued ranibizumab therapy alone among eyes with persistent DME following anti-VEGF therapy," the authors write.
Several authors disclosed financial ties to pharmaceutical companies including Genentech Inc. and Allergan Inc., which provided the ranibizumab and dexamethasone, respectively, and provided funding for the study.