Efficacy of dexamethasone versus bevacizumab on regression of hard exudates in diabetic maculopathy: data from the BEVORDEX randomised clinical trial

医学 贝伐单抗 地塞米松 糖尿病性视网膜病变 眼科 析因分析 黄斑病 曲安奈德 皮质类固醇 外科 糖尿病 内科学 视网膜病变 化疗 内分泌学
作者
Hemal Mehta,Samantha Fraser‐Bell,Aaron Yeung,Anna Campain,Lyndell L. Lim,Godfrey Quin,Ian L. McAllister,Pearse A. Keane,Mark C. Gillies
出处
期刊:British Journal of Ophthalmology [BMJ]
卷期号:100 (7): 1000-1004 被引量:35
标识
DOI:10.1136/bjophthalmol-2015-307797
摘要

Objective

To report the effect of bevacizumab versus dexamethasone on hard exudates (HEX) in diabetic macular oedema (DME).

Design

Post hoc analysis of 24-month data from the Randomised clinical trial of BEVacizumab OR DEXamethasone for diabetic macular oedema (BEVORDEX) phase 2 multicentre randomised clinical trial. Eyes with centre-involving DME resistant to or unlikely to benefit from macular laser therapy were included. Eyes were randomly assigned to bevacizumab every 4 weeks or Ozurdex dexamethasone implant (DEX) every 16 weeks, both as required. The 68 eyes from 48 patients that completed 24-month follow-up were analysed. Two masked graders assessed extent and location of HEX on baseline, 12-month and 24-month foveal-centred colour fundus photographs using validated grading software.

Results

Macular HEX was present in 60% of study eyes. Of these, 21 eyes were treated with DEX and 20 eyes with bevacizumab. Both treatments led to reduction in area of macular HEX at 12 months and 24 months. There was greater regression of HEX from the foveal centre in DEX-treated eyes (median change +890 µm, IQR=1040 µm) than bevacizumab-treated eyes (median change +7.0 µm, IQR=590 µm) at 12 months (p=0.04) but the difference was no longer statistically significant (p=0.10) by 24 months (DEX +1400 µm, IQR=1590 µm; bevacizumab +20 µm, IQR=2680 µm). Reassuringly, no study eye developed HEX at the foveal centre, a visually devastating consequence of diabetic maculopathy.

Conclusions

Bevacizumab and DEX were effective in reducing area of HEX in eyes with DME. DEX provided more rapid regression of HEX from the foveal centre although bevacizumab-treated eyes started to catch up by 24 months. Distance from the foveal centre as well as total area of macular HEX should be assessed when evaluating treatments for foveal-threatening HEX.

Trial registration number

NCT01298076; Post-results.
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