Efficacy of slow-release dexamethasone versus bevacizumab on reducing hard exudates in diabetic maculopathy: 2-year data from the Bevordex multi-centre randomised clinical trial

Purpose: To assess the long-term effect of intravitreal dexamethasone versus bevacizumab on hard exudates in diabetic maculopathy. Methods: Eyes with centre-involving diabetic macular oedema were randomly assigned to monthly bevacizumab (Avastin) or 4-monthly dexamethasone implant (DEX, Ozurdex) PRN. Eyes that had completed the 2-year BEVORDEX trial by July 1 2014 were included in this analysis. A masked grader compared the baseline and 2-year exit colour fundus photographs centred on the macula. Improvement in macula hard exudate (HEX) was assessed subjectively, and distance of the closest HEX from the foveal centre and number of ETDRS fields (0–9) containing HEX measured objectively. Statistical analysis using Fisher's exact test was performed. Results: 65 eyes from 40 patients were analysed. 42 eyes had macular HEX. Of these, 22 were treated with DEX, 20 with bevacizumab. No study eye developed HEX over the foveal centre. There was subjective improvement in HEX in 20/22 patients treated with DEX and 12/20 patients treated with bevacizumab (p < 0.05). Objectively, there was reduction in number of ETDRS fields involved in 19/22 patients treated with DEX and 11/20 patients treated with bevacizumab (p < 0.05). The closest exudate to the foveal centre was further away at 2 years compared to baseline in 19/22 patients treated with DEX and 10/20 patients treated with bevacizumab (p < 0.05). Conclusion: Over 2 years, there was a significantly greater reduction in hard exudates in eyes treated with DEX compared to eyes treated with bevacizumab. However, no study eye developed lipid precipitation at the foveal centre.