Progression of Diabetic Retinopathy in the Bevordex study: a randomized clinical trial of intravitreal bevacizumab versus intravitreal dexamethasone for diabetic macular edema

Abstract

Purpose : To compare the effect of bevacizumab (Avastin; Genentech, South Francisco, CA) with dexamethasone implants (Ozurdex; Allergan, Inc., Irvine, CA) on the progression of diabetic retinopathy (DR).

Methods : Post-hoc analysis of 24 month data from a phase 2, prospective, multicenter, randomized, single-masked clinical trial (clinicaltrials.gov identifier NCT01298076). Eightly-eight eyes of 61 patients with center-involving diabetic macular edema (DME) were recruited: 42 eyes were randomized to receive bevacizumab every 4 weeks and 46 eyes were randomized to receive a dexamethasone implant every 16 weeks, both pro re nata. Main outcome measures included change in DR severity based on reading center assessment of color fundus photographs using the modified Airlie House scale, and development of clinically important events defining high-risk proliferative diabetic retinopathy (PDR).

Results : Neither treatment showed a statistically significant propensity toward increasing or decreasing the DR grade at 1 and 2 years, with no significant difference between the two groups (p=0.71). Despite ongoing treatment, a small number of eyes developed PDR at 2 years; 1 eye (3%) receiving Bevacizumab and 7 eyes (18.9%) receiving Dexamethasone (p=0.05 Fisher’s exact test). There was no association between HbA1C, systemic blood pressure (BP) and progression of DR.

Conclusions : Both bevacizumab and dexamethasone implants have a similar effect on the progression of DR severity when administered for DME, with the majority of patients retaining the same grade on ETDRS photographic assessment after 1 and 2 years of follow up. Importantly, the development of PDR still occurred in some eyes undergoing either treatment, reinforcing the need to monitor all aspects of DR when actively managing DME with either of these treatments.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.