Intravitreal aflibercept for the treatment of patients with neovascular age-related macular degeneration in routine clinical practice in Latin America: the AQUILA study

Background AQUILA (NCT03470103) was a prospective, observational, 12-month cohort study evaluating treatment patterns, clinical effectiveness, and safety of intravitreal aflibercept (IVT-AFL) in patients from Latin America with neovascular age-related macular degeneration (nAMD). Methods Treatment-naïve and previously treated (switching to IVT-AFL) patients (aged [greater than or equal to] 55 years) were enrolled from March 2018, with a primary completion date of September 2020, from Argentina, Colombia, Costa Rica, and Mexico. Patients received IVT-AFL in a routine clinical practice setting. Results Of 274 patients in the full analysis set, 201 were treatment-naïve and 73 had received previous treatment. The mean [+ or -] standard deviation number of IVT-AFL injections received by month 12 was 4.2 [+ or -] 1.9 (treatment-naïve) and 5.2 [+ or -] 2.7 (previously treated). The median duration from diagnosis to IVT-AFL treatment was 1.2 months (treatment-naïve) and 19.5 months (previously treated). Mean best-corrected visual acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] letters) improved from baseline to month 12 by + 5.2 [+ or -] 18.3 (treatment-naïve; baseline: 48.2 [+ or -] 23.5) and + 3.1 [+ or -] 15.3 letters (previously treated; baseline: 47.7 [+ or -] 21.4). Conclusion AQUILA is the first study to assess the use of IVT-AFL in routine clinical practice in Latin America. Mean BCVA and other visual acuity outcomes improved in both treatment groups, despite many patients not receiving the IVT-AFL label-recommended regimen of three initial monthly doses, or seven or more injections in 12 months. Patients who did receive the label-recommended number of injections had numerically greater improvements in visual acuity outcomes. Patients with nAMD treated regularly and more frequently with IVT-AFL, therefore, have the potential to achieve outcomes consistent with those observed in interventional studies. Trial registration: Clinicaltrials.gov, NCT03470103. Registered February 5, 2018, Keywords: Macula, Neovascularization, Vision, Clinical trial