Dosing Regimens of Intravitreal Aflibercept for Diabetic Macular Edema Beyond the First Year: VIOLET, a Prospective Randomized Trial.
Details
Serval ID
serval:BIB_47B469687C32
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Dosing Regimens of Intravitreal Aflibercept for Diabetic Macular Edema Beyond the First Year: VIOLET, a Prospective Randomized Trial.
Journal
Advances in therapy
Working group(s)
VIOLET Investigators
Contributor(s)
Schmidt-Erfurth U., Wedrich A., Ali F., Chow D., Dickinson J., Giunta M., Hasan J., Dusova J., Hamouz J., Kodjikian L., Souied E., Dahlke C., Emmerich K.H., Feltgen N., Holz F., Koch F., Sandner D., Sekundo W., Kerenyi A., Papp A., Seres A., Vajas A., Varsanyi B., Bandello F., Boscia F., Eandi C., Midena E., Nicolo M., Peiretti E., Ricci F., Viola F., Virgili G., Balciuniene V.J., Cimbalas A., Graczynska E., Grzybowski A., Kaluzny J., Michalewska Z., Raczynska D., Rekas M., Romanowska-Dixon B., Teper S., Zarnowski T., Amaro M., Sousa J.C., Falcão M., Figueira J.P., Vaz-Pereira S., Alexik M., Gajdosova M., Pavlovicova G., Štefanickova J., Struharova K., Adan A., Barquet L.A., Bures A., Valenciano C.C., Cervera E., Sararols L., Garweg J., Petropoulos I., Lotery A., McKibbin M., Sivaprasad S., Varma D.
ISSN
1865-8652 (Electronic)
ISSN-L
0741-238X
Publication state
Published
Issued date
06/2022
Peer-reviewed
Oui
Volume
39
Number
6
Pages
2701-2716
Language
english
Notes
Publication types: Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Publication Status: ppublish
Abstract
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.
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.
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.
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.
ClinicalTrials.gov identifier: NCT02818998.
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.
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.
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.
ClinicalTrials.gov identifier: NCT02818998.
Keywords
Angiogenesis Inhibitors/adverse effects, Diabetes Mellitus/drug therapy, Diabetic Retinopathy/complications, Diabetic Retinopathy/drug therapy, Humans, Intravitreal Injections, Macular Edema/complications, Macular Edema/etiology, Prospective Studies, Receptors, Vascular Endothelial Growth Factor/therapeutic use, Recombinant Fusion Proteins/adverse effects, Treatment Outcome, Visual Acuity, Aflibercept, Diabetic retinopathy, Intravitreal injections, Macular edema, Treatment outcome, Vascular endothelial growth factor
Pubmed
Web of science
Open Access
Yes
Create date
01/02/2023 10:15
Last modification date
16/02/2023 11:08
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