We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Intravitreal aflibercept for the treatment of patients with diabetic macular edema in routine clinical practice in Latin America: the AQUILA study.
- Authors
Rodríguez, Francisco J.; Wu, Lihteh; Bordon, Arnaldo F.; Charles, Martin; Lee, JinKyung; Machewitz, Tobias; Mueller, Margarete; Gay, Gabriela del Carmen; Fromow-Guerra, Jans; the AQUILA Investigators; Reinhart, Marcelo; Caride, Gastón Gómez; Negri, Herminio; Galván, Gerónimo; Irungaray, Juan; Irós, Mariano; Vidosevich, Matko; Rivero, Noe; Zompa, Tamara; Francos, Juan Pablo
- 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
- Subjects
COSTA Rica; L'AQUILA (Italy); COLOMBIA; DIABETIC retinopathy; MACULAR edema; PEOPLE with diabetes; AFLIBERCEPT; VISUAL acuity; CLINICAL trials
- Publication
International Journal of Retina & Vitreous, 2022, Vol 8, Issue 1, p1
- ISSN
2056-9920
- Publication type
Article
- DOI
10.1186/s40942-022-00396-y