Intravitreal aflibercept for the treatment of patients with diabetic macular edema in routine clinical practice in Latin America: the AQUILA study
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Published:2022-08-02
Issue:1
Volume:8
Page:
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ISSN:2056-9920
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Container-title:International Journal of Retina and Vitreous
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language:en
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Short-container-title:Int J Retin Vitr
Author:
Rodríguez Francisco J.ORCID, Wu Lihteh, Bordon Arnaldo F., Charles Martin, Lee JinKyung, Machewitz Tobias, Mueller Margarete, Gay Gabriela del Carmen, Fromow-Guerra Jans, Reinhart Marcelo, Caride Gastón Gómez, Negri Herminio, Galván Gerónimo, Irungaray Juan, Irós Mariano, Vidosevich Matko, Rivero Noe, Zompa Tamara, Francos Juan Pablo, Salgado Paula, Caceres Barrios Gerardo, Regnasco Octavio, Rodríguez Francisco J., Piñeros Hildegard, Arias Juan, Buendia Javier, Navarro Naranjo Gustavo Adolfo, Endo Beatriz, Hernandez Myrian, Wu Lihteh, Evans Tinoco Teodoro, Garcia Gerardo, Padilla Andres, Gómez Cespedes Adriana, Dalma Jose, Cano Rene, Fromow-Guerra Jans, Saldaña Natalia, Jimenez Juan Manuel, García Franco Renata del Carmen, Solis Vivanco Adriana, Hernandez Vazquez Angeles Yael,
Abstract
Abstract
Background
AQUILA (NCT03470103) was a prospective, observational, 12-month cohort study to understand treatment patterns and to evaluate the clinical effectiveness and safety of intravitreal aflibercept (IVT-AFL) in patients from Latin America with diabetic macular edema (DME).
Methods
Treatment-naïve and previously treated (switching to IVT-AFL) patients (aged ≥ 18 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 258 patients in the full analysis set, 181 were treatment-naïve and 77 had received previous treatment. The mean ± standard deviation number of IVT-AFL injections by Month 12 was 3.7 ± 1.8 (treatment-naïve) and 4.0 ± 2.2 (previously treated). The median duration from diagnosis to IVT-AFL treatment was 1.8 months (treatment-naïve) and 16.0 months (previously treated). Mean best-corrected visual acuity (Early Treatment Diabetic Retinopathy Study letters) improved from baseline to Month 12 by + 8.1 ± 17.7 (treatment-naïve; baseline: 54.5 ± 19.4) and + 4.6 ± 15.4 letters (previously treated; baseline: 52.9 ± 18.6).
Conclusion
AQUILA is the first study to assess the use of IVT-AFL in routine clinical practice in Latin America. Despite few patients being treated with the label-recommended regimen of 5 initial monthly doses or receiving ≥ 8 injections in 12 months, functional and anatomic visual outcomes improved during 12 months of treatment with IVT-AFL. Patients receiving the label-recommended number of injections had numerically greater improvements in visual acuity outcomes. Patients with DME 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
Publisher
Springer Science and Business Media LLC
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