Abstract
Purpose :
A post hoc analysis was performed to assess the likelihood of sustained Diabetic Retinopathy Severity Scale (DRSS) score improvement in patients with diabetic macular edema (DME) who were treated with intravitreal aflibercept injection (IAI) or macular laser photocoagulation (laser control) in the VISTA and VIVID trials.
Methods :
VISTA and VIVID randomized 862 patients with DME to IAI 2 mg every 4 weeks (2q4; n=290), IAI 2 mg every 8 weeks following 5 initial monthly doses (2q8; n=286), or laser control (n=286). In this post hoc analysis, hazard ratios (HR) comparing the likelihood of achieving a sustained (2 or more consecutive DRSS evaluation visits) ≥2-step DRSS improvement in the IAI and laser control groups were estimated using Cox proportional hazards analysis. The cumulative incidences of these improvements were calculated using Kaplan-Meier analysis, and the difference between the cumulative incidence curves of the treatment groups was tested using the log-rank test. For patients who received rescue treatment, data were censored from the time rescue treatment was given.
Results :
Patients treated with IAI were significantly more likely to have a ≥2-step DRSS improvement than those treated with laser (HR [95% confidence interval [CI]]: 2q4, 2.735 [1.878, 3.985]; 2q8, 2.556 [1.751, 3.732]; p<0.0001 for both). Patients treated with IAI were also significantly more likely to have sustained ≥2-step DRSS improvement than those treated with laser (HR [95% CI]: 2q4, 3.820 [2.242–6.504]; 2q8, 3.674 [2.158–6.258]; p<0.0001 for both). The cumulative incidences of first sustained ≥2-step DRSS improvement from baseline through week 100 were significantly higher with IAI 2q4 and IAI 2q8 versus laser (40.0% and 42.8% versus 15.5%, respectively; p<0.0001 for both).
Conclusions :
These results suggest that higher proportions of patients with DME treated with IAI may achieve and sustain ≥2-step DRSS improvement compared to those treated with laser control.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.