Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2019
At the baseline Visit, subjects who met the eligibility criteria were randomized in a 1:1 ratio to receive either: ‐Brolucizumab 6 mg: 3 × 4‐week injections and one 8‐week injection, followed by Treat‐to‐ Control treatment from Week 16 up to Week 60/62 ‐Aflibercept 2 mg: 3 × 4‐week injections and one 8‐week injection, followed by Treat‐to‐Control treatment from Week 16 up to Week 60/62. For all subjects, the last potential study treatment was at the Week 60 visit (or at the Week 62 visit for subjects whose actual treatment interval would require a treatment at Week 62). The initiation phase starts on Day 1 and ends on Week 16. Treat to Control regimen starts on Week 16 until end of treatment (Week 60/62). In both treatment arms, treatment intervals after the initiation phase were either 8 weeks, 12 weeks, or 16 weeks. Per the original protocol, if it was determined that a patient required more frequent injections than q8w, he/she would be moved to a q4w treatment interval. However, this option was removed per Protocol amendment 02, after which, dosing intervals shorter than q8w were not permitted.
Epistemonikos ID: e73c9dacc75e17e51b86dc26aac3f7d8334fe4c2
First added on: May 22, 2024