As-Needed Aflibercept After the Phase 3 VISTA DME Trial: 12-Month Extension Study
American Journal of Ophthalmology, January 2017
Wykoff et al. conducted a 12-month extension study to determine whether the results achieved with aflibercept for diabetic macular edema (DME) in the 3-year VISTA DME trial could be maintained with individualized as-needed (PRN) treatment. They found that vision gains were maintained throughout the extension period and that aflibercept was well tolerated.
Sixty patients entered the ENDURANCE extension study, in which they received PRN intravitreal aflibercept injections (IAIs) for clinically relevant DME. Patients were observed at intervals of 4, 8, or 12 weeks, depending on their need for treatment. Outcome measures included the number of IAIs given through month 12, the proportion of patients not requiring any IAI, assessment of adverse events, and the use of macular laser.
The mean number of IAIs administered in the extension study was 4.5. Eighteen patients (30%) required no IAI. Among patients who met the criteria for IAI retreatment, the mean number of IAIs was 6.0. The best-corrected visual acuity achieved during VISTA DME remained stable; fluctuations from baseline were less than 1.5 (mean) letters at all assessment points of the extension study. IAI treatment was well tolerated, and no new safety signals emerged. The most common ocular adverse events were progressive diabetic retinopathy (n = 7; 12%) and worsening cataract (n = 6; 10%). Thirty-seven patients (62%) met the criteria for macular laser treatment, at a mean of 19.5 weeks. There was no significant difference in the frequency of IAIs before and after laser treatment.
The original article can be found here.