Tenecteplase Shows No Benefit Over Aspirin for Vision Recovery in Acute Retinal Artery Occlusion: NEJM
In a multicenter randomized trial, tenecteplase did not improve vision recovery compared with aspirin when given within 4.5 hours of acute central retinal artery occlusion (CRAO). The thrombolytic therapy was associated with higher safety risks, including fatal hemorrhage, and failed to improve secondary outcomes. Consistent with other recent studies, the findings leave the clinical role of thrombolysis in CRAO uncertain. The study was published in The New England Journal of Medicine by Stephan J. and colleagues.
CRAO is an ophthalmic emergency that frequently results in sudden and permanent vision loss, and there has been no treatment that has shown a clear benefit. The purpose of this study was to determine whether early intravenous thrombolysis with tenecteplase improves visual outcomes in adults with acute nonarteritic CRAO compared with standard antiplatelet therapy with aspirin.
This was a phase 3, double-blind, double-dummy, randomized controlled trial performed in 16 sites in six countries. Adults with acute nonarteritic CRAO and symptoms onset within 4.5 hours were randomly assigned in a 1:1 fashion. One group received intravenous tenecteplase 0.25 mg/kg and oral placebo, while the other group received intravenous placebo and oral aspirin 300 mg.
The primary outcome was the recovery of vision at 30 days, which was best corrected visual acuity (BCVA) of ≤0.7 logMAR, or ≥20/100. Secondary outcomes included BCVA of ≤0.5 logMAR (≥20/63), mean change in BCVA, and perimetry scores. The main safety outcomes were symptomatic intracranial hemorrhage, major bleeding, and death.
Key findings
Forty of the 78 patients were randomized to receive tenecteplase, while the remaining 38 patients received aspirin.
Eight patients (20%) in the tenecteplase group and nine patients (24%) in the aspirin group had recovered their vision after 30 days.
The risk difference was −3.7 percentage points with a 95% confidence interval of −22.0 to 14.7, and the difference was not statistically significant (P=0.69).
Secondary visual outcomes, including stricter BCVA thresholds, mean BCVA improvement, and visual field performance, also did not differ meaningfully between groups.
The tenecteplase group experienced more adverse events.
Significant safety concerns were raised when a patient on tenecteplase experienced a fatal intracranial hemorrhage.
Major bleeding events were more frequent with thrombolytic therapy than with aspirin.
Intravenous tenecteplase given within 4.5 hours of acute central retinal artery occlusion did not show any benefit in vision recovery over aspirin and was also associated with serious safety issues. This study further supports the fact that there is no effective thrombolytic treatment available for CRAO and the need for new therapies.
Reference:
Ryan, S. J., Jørstad, Ø. K., Skjelland, M., Pesonen, M., Simonsen, C. Z., Bek, T., Blauenfeldt, R. A., Ijäs, P., Laitinen, A., Khanevski, A., Krohn, J., Rødahl, E., Lemmens, R., Demeestere, J., Cassiman, C., Nakstad, I., Evensen, K., Sandell, T., Hamann, S., … TenCRAOS Investigators. (2026). A randomized trial of tenecteplase in acute central retinal artery occlusion. The New England Journal of Medicine, 394(5), 442–450. https://doi.org/10.1056/NEJMoa2508515
