A Phase III Randomized, Blind, Double Dummy, Multicenter Study Assessing the Efficacy and Safety of IV THrombolysis (Alteplase) in Patients With acutE Central retInal Artery Occlusion

Summary

The aim of the THEIA study is to determine if Alteplase administrated within 4.5 hours improve visual deficit due to acute CRAO with a good safety profile.

Timeline

Start

2018-06-08

Primary completion

2024-01-16

Completion

2024-01-16

Publications

• Preterre C, Gaultier A, Obadia M, Vignal C, Mourand I, Plat J, Sablot D, Gaudron M, Rodier G, Godeneche G, Urbanczyk C, Marc G, Massardier E, Adam S, Boulanger M, Marcel S, Mechtouff L, Ronziere T, Calviere L, Godard-Ducceschi S, Barbin L, Lebranchu P, Guillon B; THEIA collaborators. Intravenous alteplase versus oral aspirin for acute central retinal artery occlusion within 4.5 h of severe vision loss (THEIA): a multicentre, double-dummy, patient-blinded and assessor-blinded, randomised, controlled, phase 3 trial. Lancet Neurol. 2025 Nov;24(11):909-919. doi: 10.1016/S1474-4422(25)00308-4.
• Abdelmassih Y, Mauget-Faysse M, Seners P, Milea D, Hallali G, Guillaume J, Lecler A, Vignal C, Le Mer Y, Paques M, Bonnin S, Obadia M. Early reperfusion in patients with acute retinal artery occlusion: A multicenter prospective study. Int J Stroke. 2025 Mar;20(3):338-346. doi: 10.1177/17474930241306692. Epub 2024 Dec 24.

Drugs

Indications