Tenecteplase in central retinal occlusion study: TenCRAOS

Abstract

Background and aims: Central retinal artery occlusion (CRAO) is an ophthalmologic emergency that, without prompt reperfusion, bears high risk of permanent blindness. No evidence-based treatment is currently available. Whether prompt reperfusion with thrombolytic agents can improve the outcome in CRAO, as proved in ischemic stroke, remains unanswered. The main aim is to assess the effect of systemic tenecteplase within 4.5 hours of onset of central retinal artery occlusion.Methods: The trial is an ongoing prospective, randomised-controlled, double-dummy, double-blind phase 3 multi-centre trial of TNK 0.25 mg/kg + placebo vs. ASA + placebo (2 arms with 1:1 block randomisation). Patients are recruited after an ophthalmologist has confirmed CRAO and they can be treated within 4.5hrs. After observation in the stroke unit, patients will be re-examined by an ophthalmologist and a neurologist as an out-patient at 30 and 90-day follow-up.The primary outcome is the proportion of patients with ⩽ 0.7 logMAR best-corrected visual acuity (BCVA) in the affected eye at 30 days after treatment, representing an improvement in BCVA of at least 0.3 logMAR. Results: 7 countries are participating with 28 centres already activated. Currently there are 6 countries activated for recruitment. We have recruited 58 patients so far, 25 in Norway, 12 in Denmark, 9 in Finland, 5 in Belgium and 3 in Lithuania. Updated figures will be presented.Conclusions: Inclusion will continue until 78 patients have been randomized. All patients have been included within the strict parameters of the study.