Tenecteplase in Central Retinal Artery Occlusion Study (TenCRAOS): Protocol for a randomized-controlled trial

Area of Science:

• Ophthalmology
• Neurology
• Vascular Medicine

Background:

• Central retinal artery occlusion (CRAO) is an ophthalmic emergency with a high risk of permanent blindness.
• Currently, no evidence-based treatments exist for CRAO.
• Prompt reperfusion is critical to prevent vision loss.

Purpose of the Study:

• To evaluate the efficacy and safety of tenecteplase (TNK) in patients with CRAO.
• To compare TNK plus placebo versus acetylsalicylic acid (ASA) plus placebo for treating CRAO.
• To determine if TNK can improve visual acuity and patient outcomes within 4.5 hours of CRAO onset.

Main Methods:

• The TenCRAOS trial is a phase III, international, multicenter, randomized, double-blind, double-dummy study.
• Participants with CRAO and best-corrected visual acuity (BCVA) of ⩽0.1 (decimal) were randomized.
• Treatment arms included tenecteplase (TNK) 0.25 mg/kg plus placebo, or acetylsalicylic acid (ASA) 300 mg plus placebo.

Main Results:

• The primary outcome is the proportion of participants achieving a BCVA of ⩾0.2 (decimal) at 30 days.
• Secondary outcomes include improved BCVA (⩾0.32 decimal), health status, quality of life, and modified Rankin Score.
• Safety outcomes assess symptomatic intracranial hemorrhage, major bleeding, and mortality.

Conclusions:

• The TenCRAOS trial aims to establish an evidence-based treatment for CRAO.
• Systemic TNK is being investigated as a potential therapy for acute CRAO.
• The study will provide crucial data on the efficacy and safety of TNK in this critical condition.