Abstract
Purpose :
To compare multiple functional and physiological outcomes with M-CHARTS values in patients treated with aflibercept for neovascular age-related macular degeneration (nAMD) in two arms, label vs treat-and-extend (TAE).
Methods :
This prospective study randomized 41 eyes of 41 treatment-naïve patients with nAMD to two regimens. Arm 1 was treated with aflibercept according to label with three monthly injections, followed by bimonthly injections to the end of year one, thereafter the regimen changed to TAE. Arm 2 received the TAE regimen over the total study period of 18 months. Number of injections, best-corrected visual acuity (VA), near visual acuity (NVA), full-field and multifocal electroretinography (ffERG, mERG), optical coherence tomography (OCT) had been presented in a previous report. The present study evaluated M-CHARTS variables, including a questionnaire, horizontal metamorphopsia (MH), vertical metamorphopsia (MV), and vision-related quality of life (QoL) with the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25).
Results :
In arm 1, 19 eyes presented with available baseline and follow-up data for M-CHARTS values, 18 eyes in arm 2. From baseline to the final follow-up, the MV score improved significantly in arm 1 from .65±.53 to .44±.53; p=.029, and in arm 2 from .49±.48 to .20±.29; p=.007. The MH score showed significant improvements in arm 1 from .74±.55 to .41±.51; p=.028, but no significant changes in arm 2 from .64±.63 to .33±.48; p=.075. The M-CHARTS questionnaire score showed decreased subjective perception of metamorphopsia in arm 1 from 1.79±.85 to 1.58±.69; p=.331; in arm 2 from 2.17±.78 to 1.56±.784; p=.022. During the 18 months, we found no significant correlation between changes of MV, MH or M-CHARTS questionnaire results and changes of VA, NVA, ffERG, mERG, and QoL composite score. When comparing the mean change of variables over time and between regimens, we only found a statistically significant difference between the two arms in two vision-related subgroups of the NEI-VFQ-25, general vision; p=.001, and near activities; p=.012.
Conclusions :
MV emerged as statistically significant variable to follow-up and quantify metamorphopsia. As earlier described, M-CHARTS variables presented as independent parameters. The outcomes of the two aflibercept regimens showed no significant differences, besides two vision-related items of the NEI-VFQ-25.
This is a 2021 ARVO Annual Meeting abstract.