Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend for Macular Edema in Central Retinal Vein Occlusion: the CENTERA Study - 03/06/21
, Michael Larsen c, Nicole Eter d, Clare Bailey e, Sebastian Wolf f, Thomas Schmelter g, Helmut Allmeier h, Varun Chaudhary iHighlights |
• | From baseline to week 76, 65.6% of patients gained ≥15 letters. |
• | In the treat-and-extend phase, 45.0% of patients achieved a mean treatment interval of ≥8 weeks. |
• | A last actual treatment interval of ≥8 weeks was achieved by 63.1% of patients. |
• | Mean BCVA was 51.9 letters at baseline and 72.3 letters at week 76 (+20.3 letters). |
• | Mean central retinal thickness decreased from 759.9 µm at baseline to 265.4 µm at week 76 (−496.1 µm). |
Résumé |
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).
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.
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.
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 µm at baseline to 265.4 ± 57.9 µm at week 76 (mean change: −496.1 ± 252.4 µm). The safety profile of IVT-AFL was consistent with that of previous studies.
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.
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Vol 227
P. 106-115 - juillet 2021 Retour au numéro
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