Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend for Macular Edema in Central Retinal Vein Occlusion: The CENTERA Study
Résumé
PURPOSE: To evaluate the efficacy and safety of intravitreal aflibercept (IVT-AFL) treat-and-extend (T&E) dosing in patients with macular edema secondary to central retinal vein occlusion (CRVO).
DESIGN: CENTERA was an open-label, Phase 4 clinical study. METHODS: Patients received 2mg IVT-AFL at baseline and every 4 weeks (wks) until disease stability criteria were met (or until Wk20), at which point treatment intervals were adjusted in 2-wk increments based on functional and anatomic outcomes.
RESULTS: From baseline to Wk76, 65.6% (n=105; P\textbackslashtextless0.0001 [test against threshold of 40%]) of patients gained ≥15 letters; and, during the T&E phase, 45.0% (n=72; P=0.8822 [test against threshold of 50%]) of patients achieved a mean treatment interval ≥8 wks. A last and next planned treatment interval of ≥8 wks was achieved by 63.1% (n=101) and 67.5% (n=108) of patients, respectively. Mean (standard deviation) best-corrected visual acuity increased from 51.9 (16.8) letters at baseline to 72.3 (18.5) letters at Wk76 (mean change: +20.3 [19.5] letters), and central retinal thickness decreased from 759.9 (246.0) µm at baseline to 265.4 (57.9) µm at Wk76 (mean change: -496.1 [252.4] µm). The safety profile of IVT-AFL was consistent with previous studies.
CONCLUSIONS: Clinically meaningful improvements in functional and anatomic outcomes were achieved with IVT-AFL T&E dosing. Most patients achieved a last actual and last intended treatment interval of ≥8 wks, therefore treatment intervals may have been extended even further with a longer study duration.
Origine : Fichiers produits par l'(les) auteur(s)
