2-year results from an observational study of proactive treatment regimens with intravitreal aflibercept 2 mg in patients with nAMD in clinical practice: XTEND study UK cohort.

OBJECTIVES

The 36-month XTEND (NCT03939767) multicentre, observational, prospective study examined the effectiveness of proactive treatment regimens of intravitreal aflibercept (IVT-AFL) 2 mg in treatment-naïve patients with neovascular age-related macular degeneration (nAMD) in routine clinical practice. The 12- and 24-month outcomes from the XTEND UK cohort are reported.

METHODS

Patients aged ≥50 years with nAMD planned to receive IVT-AFL 2 mg were eligible. After three initial monthly IVT-AFL injections, treatment intervals could be extended in 2- to 4-weekly increments to a maximum of 16 weeks (8-week minimum treatment interval). Endpoints included mean change from baseline in best-corrected visual acuity (BCVA) and central subfield thickness (CST) at month (M) 12 and M24. Treatment intervals and safety were assessed. Statistics were descriptive.

RESULTS

In the UK, 496 patients from 23 centres were treated (mean age 79.7 years, 64.3% female). From a baseline BCVA (mean ± SD) of 55.2 ± 15.8 letters, mean (95% confidence interval [CI]) change in BCVA was +3.4 (2.0, 4.9) letters at M12 and +1.3 (- 0.3, 2.9) letters at M24. From a baseline CST (mean ± SD) of 395 ± 143 μm, mean (95% CI) change in CST was -105 ( 121, -89) μm at M12 and -105 (- 122, -88) μm at M24. By M12 and M24, patients had received a mean ± SD of 7.4 ± 2.4 and 10.7 ± 4.6 injections, respectively. Outcomes in patients enrolled prior to and during the COVID-19 pandemic were comparable. No new safety concerns were identified.

CONCLUSIONS

Despite the COVID-19 pandemic, patients in the UK achieved and maintained clinically meaningful improvements in functional and anatomic outcomes through M24.

TRIAL REGISTRATION

ClinicalTrials.gov identifier, NCT03939767.