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

Lihteh Wu; Arnaldo F Bordon; Martin Charles; Francisco J Rodríguez; JinKyung Lee; Tobias Machewitz; Margarete Mueller; Gabriela Del Carmen Gay; Jans Fromow-Guerra; AQUILA investigators

doi:10.1186/s40942-022-00425-w

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

Int J Retina Vitreous. 2022 Oct 18;8(1):76. doi: 10.1186/s40942-022-00425-w.

Authors

Lihteh Wu¹, Arnaldo F Bordon², Martin Charles³, Francisco J Rodríguez⁴, JinKyung Lee⁵, Tobias Machewitz⁵, Margarete Mueller⁵, Gabriela Del Carmen Gay⁶, Jans Fromow-Guerra⁷; AQUILA investigators

Affiliations

¹ Asociados de Macula, Vitreo y Retina de Costa Rica, Primer Piso Torre Mercedes, Calle 24, Paseo Colon, San José, 10102, Costa Rica. lihteh@gmail.com.
² Hospital Oftalmológico de Sorocaba, R. Nabek Shiroma, 210 - Jarim Emilia, Sorocaba, SP, 18031-060, Brazil.
³ Centro Oftalmológico Dr Charles, 841, C116 ABA, Riobamba, Buenos Aires, Argentina.
⁴ Fundación Oftalmológíca, Universidad del Rosario School of Medicine, Cl. 50 ##13-50, 110231, Bogotá, Colombia.
⁵ Bayer AG, 13342, Berlin, Germany.
⁶ Bayer SA, Doctor Ricardo Gutiérrez 3652, B1605EHD, Munro, Buenos Aires, Argentina.
⁷ Macula Retina Consultores, Calle Sur 132, Las Américas, Álvaro Obregón, 01120, Mexico City, Mexico.

Abstract

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 ≥ 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 ± standard deviation number of IVT-AFL injections received by month 12 was 4.2 ± 1.9 (treatment-naïve) and 5.2 ± 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 ± 18.3 (treatment-naïve; baseline: 48.2 ± 23.5) and + 3.1 ± 15.3 letters (previously treated; baseline: 47.7 ± 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, https://clinicaltrials.gov/ct2/show/NCT03470103.

Keywords: Clinical trial; Macula; Neovascularization; Vision.

Associated data

ClinicalTrials.gov/NCT03470103