{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Garweg JG"],"funding":["Bayer AG","National Institute for Health Research (NIHR)"],"pagination":["2701-2716"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9123040"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["39(6)"],"pubmed_abstract":["<h4>Introduction</h4>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.<h4>Methods</h4>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.<h4>Results</h4>Full analysis set comprised 458 patients (baseline mean BCVA: 72.5, 71.0, and 72"],"journal":["Advances in therapy"],"pubmed_title":["Dosing Regimens of Intravitreal Aflibercept for Diabetic Macular Edema Beyond the First Year: VIOLET, a Prospective Randomized Trial."],"pmcid":["PMC9123040"],"funding_grant_id":["NF-SI-0515-10020"],"pubmed_authors":["Niesen T","Kaluzny J","Viola F","Schmidt-Erfurth U","Koch F","Sandner D","Figueira JP","Sousa JC","Vaz-Pereira S","Cervera E","Lotery A","Virgili G","Zarnowski T","Sararols L","Kerenyi A","Kodjikian L","Gajdosova M","Teper S","Barquet LA","Stefanickova J","Sivaprasad S","Cimbalas A","Bandello F","Romanowska-Dixon B","Sekundo W","Varsanyi B","Vajas A","Wedrich A","Giunta M","Papp A","Garweg JG","Amaro M","Nicolo M","Peiretti E","McKibbin M","Midena E","Adan A","Hoyng C","Eandi C","Feltgen N","Chow D","Valenciano CC","Schmelter T","Dickinson J","Bures A","Balciuniene VJ","Falcao M","Struharova K","Hasan J","Leal S","Raczynska D","Grzybowski A","Ali F","VIOLET Investigators","Michalewska Z","Souied E","Graczynska E","Varma D","Hamouz J","Petropoulos I","Ricci F","Dahlke C","Pavlovicova G","Holz F","Emmerich KH","Boscia F","Dusova J","Seres A","Rekas M","Alexik M","Garweg J"],"additional_accession":[]},"is_claimable":false,"name":"Dosing Regimens of Intravitreal Aflibercept for Diabetic Macular Edema Beyond the First Year: VIOLET, a Prospective Randomized Trial.","description":"<h4>Introduction</h4>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.<h4>Methods</h4>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.<h4>Results</h4>Full analysis set comprised 458 patients (baseline mean BCVA: 72.5, 71.0, and 72","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Jun","modification":"2026-05-09T23:40:23.983Z","creation":"2025-04-04T19:32:12.997Z"},"accession":"S-EPMC9123040","cross_references":{"pubmed":["35412227"],"doi":["10.1007/s12325-022-02119-z"]}}