For the study, Dr Sivaprasad and her colleagues randomly assigned 232 people with proliferative diabetic retinopathy to either repeated intravitreal aflibercept or PRP for 52 weeks. Many of these dropped out or were found not to meet the criteria for inclusion.
After a year, 104 patients remained in the aflibercept group and 106 remained in the laser group. The patients had a baseline BCVA of fewer than 90 letters.
Patients in the aflibercept group received an intravitreal injection of 2 mg/0.05 mL at baseline, four weeks, and eight weeks. From week 12, patients were reviewed every four weeks and received aflibercept injections as needed on the basis of the extent of regression and reactivation of neovascularisation of the optic disc.
Also taken into account were clinical examinations and a comparison of seven-field colour photographs or wide-field photography at screening or previous visit.
Over the year, aflibercept patients received a mean of 4.4 injections, including the three mandated loading doses. Patients who had had no prior treatment received a mean of 4.6, while those who had been treated with PRP received a mean of 4.1.
The mean difference in the BCVA letter score between the aflibercept and PRP arms was smallÂÂÂÂÂÂÂÂÂ—3.9 letters—but it was statistically significant (p < 0.0001), and slightly higher if the patients who dropped out were not considered. It was achieved with a median of one aflibercept injection in the 40 weeks post-loading phase.