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

Autor: Garweg, Justus G., Štefanickova, Jana, Hoyng, Carel, Niesen, Tobias, Schmelter, Thomas, Leal, Sergio, Sivaprasad, Sobha, the VIOLET Investigators, Schmidt-Erfurth, Ursula, Wedrich, Andreas, Ali, Fareed, Chow, David, Dickinson, John, Giunta, Michel, Hasan, Jesia, Dusova, Jaroslava, Hamouz, Jan, Kodjikian, Laurent, Souied, Eric, Dahlke, Claudia
Zdroj: Advances in Therapy; Jun2022, Vol. 39 Issue 6, p2701-2716, 16p
Abstrakt: 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. Trial Registration: ClinicalTrials.gov identifier: NCT02818998. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index
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