Early Reperfusion Therapy With Intravenous Thrombolysis for Recovery of VISION in Acute Central Retinal Artery Occlusion

Summary

Non-arteritic, thromboembolic central retinal artery occlusion (CRAO) is an acute neurovascular-ophthalmological emergency which leads to severe and permanent vision loss; no evidence-based therapy does exist. Two recent meta-analyses indicate early intravenous thrombolysis to be beneficial in CRAO. Therefore, the REVISION randomized placebo-controlled interventional trial will investigate intravenous alteplase in CRAO as it is practiced in acute ischemic stroke, i.e. within 4.5 hours after symptom onset. The REVISION observational study will evaluate retinal changes on optical coherence tomography (OCT) in patients within 12 hours of CRAO onset, and the REVISION substudy, which will be conducted adjunct to either the interventional or the observational study, will evaluate the value of the retrobulbar spot sign for prediction of outcome and treatment response.

Timeline

Start

2022-10-10

Primary completion

2026-03-23

Completion

2026-04-29

Publications

• Background Poli S, Grohmann C, Wenzel DA, Poli K, Tunnerhoff J, Nedelmann M, Fiehler J, Burghaus I, Lehmann M, Glauch M, Schadwinkel HM, Kalmbach P, Zeller J, Peters T, Eschenfelder C, Agostini H, Campbell BC, Fischer MD, Sykora M, Mac Grory B, Feltgen N, Kowarik M, Seiffge D, Strbian D, Albrecht M, Alzureiqi MS, Auffarth G, Bazner H, Behnke S, Berberich A, Bode F, Bohmann FO, Cheng B, Czihal M, Danyel LA, Dimopoulos S, Pinhal Ferreira de Pinho JD, Fries FN, Gamulescu MA, Gekeler F, Gomez-Exposito A, Gumbinger C, Guthoff R, Hattenbach LO, Kellert L, Khoramnia R, Kohnen T, Kurten D, Lackner B, Laible M, Lee JI, Leithner C, Liegl R, Lochner P, Mackert M, Mbroh J, Muller S, Nagel S, Prasuhn M, Purrucker J, Reich A, Mundiyanapurath S, Royl G, Salchow DJ, Schafer JH, Schlachetzki F, Schmack I, Thomalla G, Tieck Fernandez MP, Wakili P, Walter P, Wolf A, Wolf M, Bartz-Schmidt KU, Schultheiss M, Spitzer MS. Early REperfusion therapy with intravenous alteplase for recovery of VISION in acute central retinal artery occlusion (REVISION): Study protocol of a phase III trial. Int J Stroke. 2024 Aug;19(7):823-829. doi: 10.1177/17474930241248516. Epub 2024 Jun 25.
• Background Mac Grory B, Preterre C, Lebranchu P, Ryan SJ, Jorstad OK, Moe MC, Tunnerhoff J, Spitzer MS, Grohmann C, Dumitrascu OM, Biousse V, Guillon B, Aamodt AH, Poli S, Schrag M; Central Retinal ArterY OcclusioN (CRAYON) Collaborators. Intravenous thrombolysis for acute central retinal artery occlusion: Protocol for a systematic review and individual participant data meta-analysis of randomized controlled trials. PLoS One. 2026 Mar 10;21(3):e0342739. doi: 10.1371/journal.pone.0342739. eCollection 2026.

Drugs

Indications