Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend for Macular Edema in Central Retinal Vein Occlusion: the CENTERA Study

center dot PURPOSE: To evaluate the efficacy and safety of intravitreal aflibercept (IVT-AFL) treat-and-extend dosing in patients with macular edema secondary to central retinal vein occlusion (CRVO). center dot DESIGN: CENTERA (Evaluation of a Treat and Extend Regimen of Intravitreal Aflibercept for Macular Edema Secondary to CRVO; NCT02800642) was an open-label, Phase 4 clinical study. center dot METHODS: Patients received 2 mg of IVT-AFL at baseline and every 4 weeks thereafter, until disease stability criteria were met (or until week 20), at which point treatment intervals were adjusted in 2-week increments based on functional and anatomic outcomes. center dot RESULTS: From baseline to week 76, 105 patients (65.6%) ( P < .0001 [test against threshold of 40%]) gained >15 letters; and, during the treat-and-extend phase, 72 patients (45.0%) ( P = 0.8822 [test against threshold of 50%]) achieved a mean treatment interval of >8 weeks. A last and next planned treatment interval of >8 weeks was achieved by 101 patients (63.1%) and by 108 patients (67.5%), respectively. Mean +/- SD best-corrected visual acuity increased from 51.9 +/- 16.8 letters at baseline to 72.3 +/- 18.5 letters at week 76 (mean change: + 20.3 +/- 19.5 letters), and central retinal thickness decreased from 759.9 +/- 246.0 & micro;m at baseline to 265.4 +/- 57.9 & micro;m at week 76 (mean change: & minus;496.1 +/- 252.4 & micro;m). The safety profile of IVT-AFL was consistent with that of previous studies. center dot CONCLUSIONS: Clinically meaningful improvements in functional and anatomic outcomes were achieved with IVT-AFL treat-and-extend dosing. Most patients achieved a last actual and last intended treatment interval of >8 weeks; therefore, treatment intervals may have been extended even further with a longer study duration. (Am J Ophthalmol 2021;227: 106-115. (c) 2021 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY-NC ND license ( http://creativecommons.org/licenses/by-ncnd/4.0/ ))