Two-year results from a global observational study investigating proactive dosing regimens with intravitreal aflibercept in neovascular age-related macular degeneration (nAMD) in routine clinical practice: the XTEND study

Abstract

Purpose : The 36-month XTEND (NCT03939767) multicenter, observational, prospective study examined the effectiveness of proactive treatment regimens of intravitreal aflibercept (IVT-AFL) in treatment-naïve patients with nAMD in routine clinical practice. Fourteen countries with European Medicines Agency (EMA)-aligned and three countries with non-EMA-aligned labels were included.

Methods : Patients aged ≥50 years with nAMD were eligible if planned to receive 2 mg IVT-AFL according to the approved label. The label-specified regimens were EMA-aligned (8-week minimum treatment interval in Year 1 after three initial monthly IVT-AFL injections), or non-EMA-aligned (4-week minimum treatment interval in Year 1 after three initial monthly IVT-AFL injections). Treatment intervals could be extended in 2-/4-weekly increments to a maximum of 12/16 weeks. Primary endpoint was mean change from baseline in best-corrected visual acuity (BCVA), Early Treatment Diabetic Retinopathy Study letters at Month 12. Statistics were descriptive.

Results : We present 2-year results from the ongoing XTEND study, which coincided with the peak of the COVID-19 pandemic. In total, 1466 patients (mean age 79 years, 61% female) were included. Results were consistent across both labels, and overall results are presented. The majority (88%) of patients were intended to receive a treat-and-extend regimen; proactive fixed-dosing regimen was planned for the remaining patients. From baseline (BL) (mean±SD: 54.3±20.3 letters), mean change (95% CI) in BCVA was +4.3 (3.4, 5.3) letters after 1 year, and +2.3 (1.3, 3.3) letters after 2 years. In patients who had a mean BL BCVA ≥70 letters (75.0±5.0), vision was maintained after 1 and 2 years (74.3±12.0 and 72.0±15.1). Patients received a mean±SD of 7.7±2.7 IVT-AFL injections over 1 year and 10.8±5.0 injections over 2 years. Mean±SD change from BL in central retinal thickness was −106±129 μm during 1 year and −109±130 μm during 2 years. No new safety concerns were identified.

Conclusions : In the XTEND study, the majority of patients achieved and maintained robust functional and anatomic improvements. For patients who had a BL BCVA ≥70 letters, BCVA was maintained above 70 letters during the first 2 years of the ongoing 3-year study.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.