Introduction The purpose was to compare two flexible regimens of intravitreal aflibercept (IVT-AFL) with fixed dosing every 8 weeks, beyond the first year of treatment, in patients with diabetic macular edema (DME). VIOLET was a 100-week, randomized, Phase IIIb, non-inferiority study in patients with center-involving DME previously treated with IVT-AFL for >= 1 year according to the European label. Methods Patients received an initial dose of IVT-AFL at study baseline and were randomly assigned (1:1:1) to treat-and-extend (T&E), pro re nata (PRN), or fixed regimens. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline (randomization) to Week 52. Results Full analysis set comprised 458 patients (baseline mean BCVA: 72.5, 71.0, and 72.7 letters in the T&E, PRN, and fixed-dose groups, respectively). Patients received a mean (min-max) of 10.0 (2-14; T&E), 11.5 (1-25; PRN), and 12.3 (3-13; fixed) injections over 100 weeks, with 13.3 (4-23), 25.0 (3-29), and 16.1 (5-25) clinic visits, respectively. At Week 52, mean (+/- standard deviation) BCVA changes from baseline were + 0.5 +/- 6.7 (T&E), + 1.7 +/- 6.8 (PRN), and + 0.4 +/- 6.7 (fixed-dosing) letters (least squares mean difference [95% confidence interval]: T&E 0.01 [- 1.46, 1.47] and PRN 0.95 (- 0.52, 2.42) letters versus fixed dosing; p < 0.0001 for both non-inferiority tests [4-letter margin]). The IVT-AFL safety profile was consistent with previous studies. Conclusion The treatment burden associated with intravitreal injections for DME is lowest with T&E regimens, but there are a range of flexible IVT-AFL dosing regimens, allowing physicians to adopt an individualized treatment plan.

Dosing Regimens of Intravitreal Aflibercept for Diabetic Macular Edema Beyond the First Year: VIOLET, a Prospective Randomized Trial / J.G. Garweg, J. ??tefanickova, C. Hoyng, T. Niesen, T. Schmelter, S. Leal, S. Sivaprasad, U. Schmidt-Erfurth, A. Wedrich, F. Ali, D. Chow, J. Dickinson, M. Giunta, J. Hasan, J. Dusova, J. Hamouz, L. Kodjikian, E. Souied, C. Dahlke, K. Emmerich, N. Feltgen, F. Holz, F. Koch, D. Sandner, W. Sekundo, A. Kerenyi, A. Papp, A. Seres, A. Vajas, B. Varsanyi, F. Bandello, F. Boscia, C. Eandi, E. Midena, M. Nicolo, E. Peiretti, F. Ricci, F. Viola, G. Virgili, V. Balciuniene, A. Cimbalas, E. Graczynska, A. Grzybowski, J. Kaluzny, Z. Michalewska, D. Raczynska, M. Rekas, B. Romanowska-Dixon, S. Teper, T. Zarnowski, M. Amaro, J. Castro Sousa, M. Falc??o, J. Pereira Figueira, S. Vaz-Pereira, M. Alexik, M. Gajdosova, G. Pavlovicova, J. ??tefanickova, K. Struharova, A. Adan, L. Arias Barquet, A. Bures, C. Cava Valenciano, E. Cervera, L. Sararols, J. Garweg, I. Petropoulos, A. Lotery, M. Mckibbin, S. Sivaprasad, D. Varma. - In: ADVANCES IN THERAPY. - ISSN 0741-238X. - 39:6(2022 Jun), pp. 2701-2716. [10.1007/s12325-022-02119-z]

Dosing Regimens of Intravitreal Aflibercept for Diabetic Macular Edema Beyond the First Year: VIOLET, a Prospective Randomized Trial

F. Viola;
2022

Abstract

Introduction The purpose was to compare two flexible regimens of intravitreal aflibercept (IVT-AFL) with fixed dosing every 8 weeks, beyond the first year of treatment, in patients with diabetic macular edema (DME). VIOLET was a 100-week, randomized, Phase IIIb, non-inferiority study in patients with center-involving DME previously treated with IVT-AFL for >= 1 year according to the European label. Methods Patients received an initial dose of IVT-AFL at study baseline and were randomly assigned (1:1:1) to treat-and-extend (T&E), pro re nata (PRN), or fixed regimens. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline (randomization) to Week 52. Results Full analysis set comprised 458 patients (baseline mean BCVA: 72.5, 71.0, and 72.7 letters in the T&E, PRN, and fixed-dose groups, respectively). Patients received a mean (min-max) of 10.0 (2-14; T&E), 11.5 (1-25; PRN), and 12.3 (3-13; fixed) injections over 100 weeks, with 13.3 (4-23), 25.0 (3-29), and 16.1 (5-25) clinic visits, respectively. At Week 52, mean (+/- standard deviation) BCVA changes from baseline were + 0.5 +/- 6.7 (T&E), + 1.7 +/- 6.8 (PRN), and + 0.4 +/- 6.7 (fixed-dosing) letters (least squares mean difference [95% confidence interval]: T&E 0.01 [- 1.46, 1.47] and PRN 0.95 (- 0.52, 2.42) letters versus fixed dosing; p < 0.0001 for both non-inferiority tests [4-letter margin]). The IVT-AFL safety profile was consistent with previous studies. Conclusion The treatment burden associated with intravitreal injections for DME is lowest with T&E regimens, but there are a range of flexible IVT-AFL dosing regimens, allowing physicians to adopt an individualized treatment plan.
Aflibercept; Diabetic retinopathy; Intravitreal injections; Macular edema; Treatment outcome; Vascular endothelial growth factor
Settore MED/30 - Malattie Apparato Visivo
12-apr-2022
Article (author)
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/944572
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