Long-term Outcome of Intravitreal Aflibercept Treatment for Neovascular Age-Related Macular Degeneration Using a "Treat-and-Extend" Regimen.

PURPOSE

To report outcomes in patients with neovascular age-related macular degeneration (nAMD) after treatment with aflibercept for up to 4 years using a treat-and-extend (T&E) regimen.

DESIGN

Observational study.

PARTICIPANTS

Patients with newly diagnosed nAMD treated with aflibercept in a T&E protocol.

METHODS

Subjects received 3 injections of aflibercept at monthly intervals followed by a T&E protocol for at least 12 months. At each clinical visit after the loading phase, OCT and best-corrected visual acuity (BCVA) testing were performed to monitor disease activity.

MAIN OUTCOME MEASURES

Change in BCVA over time, number of injections and visits per year, and percentage of patients reaching a treatment interval of ≥12 weeks.

RESULTS

Of 231 consecutive eyes (231 patients) with a mean follow-up time of 2.9 (1-5.5) years, 173 were followed up for ≥2 years, 112 were followed up for ≥3 years, and 62 were followed up for ≥4 years. Mean BCVA increased from 59.8 letters (20/60) at diagnosis to 65.8 letters (20/50) after the loading phase (+6.0 letters; standard deviation [SD], 11.1) and to 65.5 letters at 12 months (+5.7 letters; [SD], 17). After 4 years of treatment, mean BCVA was maintained insignificantly better than baseline (63.4 letters, +3.6 letters gain, SD, 20.6; P > 0.05). To achieve this, a mean of 7.7 (±1.2) injections and 4.4 (±1.6) clinic visits in the first year and 4.4 (±1.9) injections and 4.3 (±1.3) clinical visits per year thereafter were required. By 2 years of follow-up, 46.9% of patients reached a treatment interval of ≥12 weeks.

CONCLUSIONS

By using a T&E regimen, patients with nAMD maintained stable visual function over 4 years in a real-world setting with a reasonable treatment burden.