TenCRAOS was a phase 3 randomized, multi-center, double blind, double dummy, placebo-controlled trial in 78 patients that showed no significant difference in visual outcomes at 30 days for IV tenecteplase 0.25 mg/kg compared to aspirin 300 mg alone within 4.5 hours of central retinal artery occlusion (CRAO) symptom onset. Tenecteplase was associated with more serious adverse events, one of which was a fatal intracerebral hemorrhage.  

Bottom line: Although tenecteplase has theoretical advantages in CRAO, the results of this trial do not support routine use.

Additional Information

Study design:

• Phase 3 randomized, multi-center, double blind, double dummy, placebo-controlled trial
• Included patients with CRAO diagnosed with best corrected visual acuity (BCVA) of 1.0 log-MAR or greater in the affected eye and were able to receive treatment within 4.5 hours
• Interventions: Tenecteplase 0.25 mg/kg (max of 25 mg) + oral placebo vs. oral aspirin 300 mg + IV placebo (randomized 1:1)
• Primary endpoint: BCVA of 0.7 log-MAR or lower in the affected eye at 30 days after treatment (Considered a clinically meaningful improvement in visual acuity on the Early Treatment Diabetic Retinopathy Study Chart)

Results:

• 78 patients included in final analysis (40 in tenecteplase group and 38 in aspirin group)
• No significant difference in the number of patients with BCVA of 0.7 log-MAR or lower for tenecteplase compared to aspirin (20% vs 24%, risk difference -0.04 (-0.22 to 0.15). Result was consistent across all visual efficacy endpoints and among a subgroup of patients treated within 3 hours of symptom onset.
• Adverse events occurred in 48% of patients in the tenecteplase group and 34% in the aspirin group.
  • More serious adverse events in the tenecteplase group (10 events among 8 patients vs. 4 events among 4 patients in the aspirin group)
  • One serious adverse event attributed to tenecteplase was fatal. Event involved ongoing cerebral ischemia that was not apparent on head CT or clinically. Multiple intracerebral hemorrhages caused by reperfusion of damaged brain tissue developed after tenecteplase administration.

References

Ryan SJ, Jørstad ØK, Skjelland M, Pesonen M, Simonsen CZ, Bek T et al.  A randomized trial of tenecteplase in central retinal artery occlusion. N Engl J Med. 2026. 394(5): 442-450.