Publications by authors named "Tobias Niesen"
Article Synopsis
- The AZURE study was a 76-week clinical trial comparing two treatment regimens of aflibercept in patients with neovascular age-related macular degeneration, evaluating a flexible treat-and-extend approach versus a fixed dosing schedule.
- Patients aged 51 and older who had been on aflibercept for at least a year were randomly assigned to receive either a treat-and-extend regimen or fixed dosing every 8 weeks, with changes monitored based on visual acuity and anatomical results.
- Results showed that both regimens produced similar changes in best-corrected visual acuity, with high rates of vision maintenance, and the treat-and-extend approach allowed for longer intervals between treatments for some patients without any new safety concerns.
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.
Purpose: To examine vision-related quality of life in patients with diabetic macular edema (DME) treated with intravitreal aflibercept (EYLEA, Regeneron Pharmaceuticals, Inc, Tarrytown, NY).
Design: AQUA was a multicenter, open-label, single-arm, phase 4 study.
Participants: Adults 18 years of age or older with type 1 or 2 diabetes mellitus and DME.