At 52 weeks, 89% of patients in the aflibercept group had no macular oedema, compared with 71% in the PRP arm. The incidence of vitreous haemorrhage was 18% in the PRP group, compared to 9% in the aflibercept group.
Five percent of the patients in the aflibercept group improved by at least ten letters compared with only 2% of the patients in the PRP group. However, the difference was not statistically significant (p = 0.45).
Only two patients required supplementary PRP in the aflibercept group.
From week 12, 65% of patients in the PRP arm required supplementary PRP. The mean number of supplementary PRP sessions required was 1.17, with patients receiving their first treatments having a mean of 1.35 supplementary sessions and the others averaging a mean of 0.96.
In the PRP arm, 69% received multi-spot laser, whilst the remaining patients received single spot laser.
This investigator-initiated study was funded predominantly by the UK Efficacy and Mechanism Evaluation programme and managed by the National Institute for Health Research on behalf of the Medical Research Council. The treatment, aflibercept solution for injection, was supplied by Bayer Plc, Reading, UK. Bayer also provided an unrestricted grant toward study costs.
Dr Sivaprasad received research grants, travel grants, speaker fees and attended advisory board members of Novartis, Bayer, Allergan and Roche. The co-lead for the study has received research grants, travel grants, speaker fees and attended advisory board members of Novartis, Bayer and Allergan. The other named authors declare that they have no competing interests.
Aflibercept is not approved for PDR in the UK; it is only approved for neovascular age-related macular degeneration and for visual impairment due to macular oedema secondary to retinal vein occlusion, diabetic macular oedema, or myopic choroidal neovascularisation.