biostudies-literatureGarweg JGBayer AGNational Institute for Health Research (NIHR)2701-2716https://www.ebi.ac.uk/biostudies/studies/S-EPMC9123040biostudies-literatureUnknown39(6)<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 72Advances in therapyDosing Regimens of Intravitreal Aflibercept for Diabetic Macular Edema Beyond the First Year: VIOLET, a Prospective Randomized Trial.PMC9123040NF-SI-0515-10020Niesen TKaluzny JViola FSchmidt-Erfurth UKoch FSandner DFigueira JPSousa JCVaz-Pereira SCervera ELotery AVirgili GZarnowski TSararols LKerenyi AKodjikian LGajdosova MTeper SBarquet LAStefanickova JSivaprasad SCimbalas ABandello FRomanowska-Dixon BSekundo WVarsanyi BVajas AWedrich AGiunta MPapp AGarweg JGAmaro MNicolo MPeiretti EMcKibbin MMidena EAdan AHoyng CEandi CFeltgen NChow DValenciano CCSchmelter TDickinson JBures ABalciuniene VJFalcao MStruharova KHasan JLeal SRaczynska DGrzybowski AAli FVIOLET InvestigatorsMichalewska ZSouied EGraczynska EVarma DHamouz JPetropoulos IRicci FDahlke CPavlovicova GHolz FEmmerich KHBoscia FDusova JSeres ARekas MAlexik MGarweg JfalseDosing Regimens of Intravitreal Aflibercept for Diabetic Macular Edema Beyond the First Year: VIOLET, a Prospective Randomized Trial.<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 722022-01-01T00:00:00Z2022 Jun2026-05-09T23:40:23.983Z2025-04-04T19:32:12.997ZS-EPMC91230403541222710.1007/s12325-022-02119-z