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Dosing Regimens of Intravitreal Aflibercept for Diabetic Macular Edema Beyond the First Year: VIOLET, a Prospective Randomized Trial
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 wi...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer Healthcare
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9123040/ https://www.ncbi.nlm.nih.gov/pubmed/35412227 http://dx.doi.org/10.1007/s12325-022-02119-z |
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author | Garweg, Justus G. Štefanickova, Jana Hoyng, Carel Niesen, Tobias Schmelter, Thomas Leal, Sergio Sivaprasad, Sobha |
author_facet | Garweg, Justus G. Štefanickova, Jana Hoyng, Carel Niesen, Tobias Schmelter, Thomas Leal, Sergio Sivaprasad, Sobha |
author_sort | Garweg, Justus G. |
collection | PubMed |
description | 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12325-022-02119-z. |
format | Online Article Text |
id | pubmed-9123040 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-91230402022-05-22 Dosing Regimens of Intravitreal Aflibercept for Diabetic Macular Edema Beyond the First Year: VIOLET, a Prospective Randomized Trial Garweg, Justus G. Štefanickova, Jana Hoyng, Carel Niesen, Tobias Schmelter, Thomas Leal, Sergio Sivaprasad, Sobha Adv Ther Original Research 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s12325-022-02119-z. Springer Healthcare 2022-04-12 2022 /pmc/articles/PMC9123040/ /pubmed/35412227 http://dx.doi.org/10.1007/s12325-022-02119-z Text en © The Author(s) 2022 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Original Research Garweg, Justus G. Štefanickova, Jana Hoyng, Carel Niesen, Tobias Schmelter, Thomas Leal, Sergio Sivaprasad, Sobha Dosing Regimens of Intravitreal Aflibercept for Diabetic Macular Edema Beyond the First Year: VIOLET, a Prospective Randomized Trial |
title | Dosing Regimens of Intravitreal Aflibercept for Diabetic Macular Edema Beyond the First Year: VIOLET, a Prospective Randomized Trial |
title_full | Dosing Regimens of Intravitreal Aflibercept for Diabetic Macular Edema Beyond the First Year: VIOLET, a Prospective Randomized Trial |
title_fullStr | Dosing Regimens of Intravitreal Aflibercept for Diabetic Macular Edema Beyond the First Year: VIOLET, a Prospective Randomized Trial |
title_full_unstemmed | Dosing Regimens of Intravitreal Aflibercept for Diabetic Macular Edema Beyond the First Year: VIOLET, a Prospective Randomized Trial |
title_short | Dosing Regimens of Intravitreal Aflibercept for Diabetic Macular Edema Beyond the First Year: VIOLET, a Prospective Randomized Trial |
title_sort | dosing regimens of intravitreal aflibercept for diabetic macular edema beyond the first year: violet, a prospective randomized trial |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9123040/ https://www.ncbi.nlm.nih.gov/pubmed/35412227 http://dx.doi.org/10.1007/s12325-022-02119-z |
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