A 6-month, subject-masked, randomized controlled study to assess efficacy of dexamethasone as an adjunct to bevacizumab compared with bevacizumab alone in the treatment of patients with macular edema due to central or branch retinal vein occlusion

Abstract

Raj K Maturi,1,2 Vincent Chen,3 Dan Raghinaru,3 Laurie Bleau,1 Michael W Stewart4 1Midwest Eye Institute, Indianapolis, IN, USA; 2Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, IN, USA; 3Jaeb Center for Health Research, Tampa, FL, USA; 4Department of Ophthalmology, Mayo Clinic, Jacksonville, FL, USA Aims: To determine if intravitreal bevacizumab combined with the dexamethasone intravitreal implant 0.7 mg improves visual acuity and macular thickness more than bevacizumab monotherapy in eyes with macular edema due to branch and central retinal vein occlusions. Methods: Thirty eyes were randomly assigned to receive either combination therapy or bevacizumab monotherapy. All patients received intravitreal bevacizumab at baseline, followed by dexamethasone implants or sham injections 1 week later. Monthly bevacizumab injections were given if the central subfield thickness (CST) was >250 µm, and the combined group received a second implant at month 4 or 5 if CST was >250 µm. Results: At 6 months, several secondary endpoints were met. Patients receiving combined therapy required fewer bevacizumab reinjections compared to those receiving monotherapy (two versus three; P=0.02), experienced greater mean reductions in CST from randomization (–56 µm versus +45 µm; P=0.01), and were more likely to have resolved all edema (CST <250 µm) (7/11 versus 2/14; P=0.02). The primary endpoint was not met since mean visual acuity changes from baseline were similar in the two groups (P=0.75). Conclusion: In patients with macular edema due to vein occlusions, bevacizumab with dexamethasone implants produces greater improvements in macular thickness compared to bevacizumab monotherapy, despite fewer bevacizumab injections. Keywords: dexamethasone implant, central retinal vein occlusion, branch retinal vein occlusion, vascular endothelial growth factor