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Randomised clinical trial of intravitreal bevacizumab versus intravitreal dexamethasone for diabetic macular edema. The BEVORDEX study

Session Details

Session Title: Vascular Diseases and Diabetic Retinopathy I

Session Date/Time: Thursday 11/09/2014 | 08:00-10:00

Paper Time: 09:28

Venue: Boulevard C

First Author: : M.Gillies AUSTRALIA

Co Author(s): :    L. Lim   A. Campain   W. Salem   C. Aroney   I. McAllister   M. Gillies

Abstract Details

Purpose:

Intravitreal injections of slow-release steroids, such as dexamethasone (DEX implant, Ozurdex), and inhibitors of Vascular Endothelial Growth Factor, such as bevacizumab (Avastin), have both been shown to be efficacious for centre-involving diabetic macular oedema (DMO). The purpose of this study was to compare bevacizumab to DEX implant for the treatment of DMO at one year.

Setting:

Phase II, prospective, multicentre, randomised, single-masked clinical trial was performed in 4 Australian sites, Clinicaltrial.gov#NCT01298076.

Methods:

We enrolled 88 eyes of 61 patients, of which 42 eyes were randomised to receive bevacizumab monthly and 46 to DEX implant 4 monthly, both pro re nata. The primary outcome was the proportion of eyes that improved by 10 LogMAR letters. Secondary outcomes included mean change in best corrected visual acuity (BCVA), change in OCT measured central macular thickness (CMT), and adverse events. Results were analysed using linear regression with generalized estimation equations methods to account for between eye correlation.

Results:

Improvement in BCVA of 10 or more letters occurred in 17 of 42 (40%) eyes treated with bevacizumab and 18 of 46 (39%) of eyes treated with the DEX implant (p=0.83). None of the 42 bevacizumab eyes lost 10 or more letters, whereas 5 of 46 (11%) DEX implant did, which was mostly due to unoperated cataract. The mean improvement in BCVA was 8.9 letters, (95% confidence interval [CI], 6.27-11.6) for bevacizumab treated eyes and 5.6 (95% CI, 0.90-10.4) for DEX implant eyes (p=0.24). The mean CMT at 12months was significantly greater for bevacizumab than DEX implant eyes (380.6 vs.285.0 microns, p=0.007). Bevacizumab eyes received a mean of 8.8 injections vs 2.8 for DEX implant eyes. Of 24 patients with both eyes in the study that received both drugs, 11 (46%) preferred DEX implant, 8 (33%) preferred bevacizumab and 5 (21%) had no preference.

Conclusions:

Both DEX implant and bevacizumab can improve vision in eyes with diabetic macular oedema. We found no significant difference between the 2 groups with respect to vision gain. While more DEX implant eyes lost vision, the 2-year analysis of this study will include the effect of steroid-induced cataract and its removal.

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