Two-Year Outcomes of Treat-and-Extend Intravitreal Aflibercept for Exudative Age-Related Macular Degeneration: A Prospective Study.

PURPOSE

To report the 2-year outcomes of intravitreal aflibercept injections (IAIs) in Japanese patients with neovascular age-related macular degeneration (AMD) using a 1-month adjusted treat-and-extend (TAE) regimen.

DESIGN

Multicenter, prospective, nonrandomized, interventional study.

PARTICIPANTS

Ninety-seven eyes of 97 patients with treatment-naive AMD were studied at 3 tertiary ophthalmological institutions.

METHODS

The patients were treated with 3 consecutive monthly IAIs followed by the TAE regimen with a 1-month adjustment for a maximum of 3 months. Our TAE regimen allowed us to shorten and extend the treatment intervals even after a 3-month or 1-month treatment interval, or both, were reached. Best-corrected visual acuity (BCVA), central retinal thickness (CRT), and subfoveal choroidal thickness (SCT) were analyzed.

MAIN OUTCOME MEASURES

The mean changes in the BCVA, CRT, and SCT from the baseline to 2 years after initiating the treatment were determined. In addition, the number of injections also was determined.

RESULTS

The mean BCVA significantly improved from 0.27 logarithm of the minimum angle of resolution (logMAR) units to 0.14 logMAR at 2 years (P < 0.01). The mean CRT decreased significantly from 307±132 μm to 202±76 μm at 2 years (P < 0.01). The mean SCT decreased significantly from 247±106 μm to 203±96 μm at 2 years (P < 0.01). Seventy eyes (72.2%) showed a dry macula at 2 years. The treatment interval at 2 years was 1 month in 20 eyes (20.6%), 2 months in 18 eyes (18.6%), and 3 months in 59 eyes (60.8%). In 49 (50.5%) eyes with a 3-month treatment interval immediately after the loading phase, no fluid was seen in 25 eyes (51.0%) for the duration of this study. The rest had switched to a more frequent scheme. The mean number of injections during the 2-year period was 13.0±3.9.

CONCLUSIONS

Intravitreal aflibercept injections with a 1-month adjusted TAE regimen significantly improved the BCVA and CRT with a reduced number of injections at 2 years. The treatment interval was adjusted to extend to 3 months in 60% and to shorten to 1 month in 20% of the eyes at 2 years.