Produção Nacional
Revisado por pares
Intravitreal aflibercept for the treatment of patients with diabetic macular edema in routine clinical practice in Latin America: the AQUILA study
2022; BioMed Central; Volume: 8; Issue: 1 Linguagem: Inglês
10.1186/s40942-022-00396-y
ISSN2056-9920
AutoresFrancisco J. Rodríguez, Lihteh Wu, Arnaldo Furman Bordon, Martin Charles, JinKyung Lee, Tobias Machewitz, Margarete Mueller, Gabriela del Carmen Gay, Jans Fromow-Guerra, Marcelo Reinhart, Gastón Gómez Caride, Herminio Negri, Gerónimo Galván, Juan Irungaray, Mariano Irós, Matko Vidosevich, Noe Rivero, Tamara Zompa, Juan Pablo Francos, Paula S. Salgado, Gerardo Caceres Barrios, Octavio Regnasco, Francisco J. Rodríguez, Hildegard Piñeros, Juan C. Arias, Javier Buendía, Gustavo Adolfo Navarro Naranjo, Beatriz Endo, Myrian Hernandez, Lihteh Wu, Teodoro Evans Tinoco, Gerardo García, Andres Padilla, Adriana Gómez Cespedes, Jose Dalma, Rene Cano, Jans Fromow-Guerra, Natalia Saldaña, Juan Manuel Miguel Jiménez, Renata del Carmen García Franco, Adriana Solis Vivanco, Angeles Yael Hernandez Vazquez,
Tópico(s)Retinal and Optic Conditions
ResumoAbstract 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
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