A Phase III Randomized, Blind, Double Dummy, Multicenter Study Assessing the Efficacy and Safety of IV THrombolysis (Alteplase) in Patients With acutE Central retInal Artery Occlusion

Inclusion criteria

• Patients aged up to 18 years
• CRAO diagnosis by fundoscopic examination or non-mydriatic retinophotography (NMR) performed by an ophthalmologist.
• Blindness defined according to WHO classification as visual acuity <1/20 (20/400).
• Treatment intervention should be initiated by a stroke team as quickly as possible and within 4.5 hours from symptom onset.
• No clinical (e.g headache with jaw claudication or scalp tenderness, no temporal pulse) or laboratory evidence (elevated CRP) of giant cell arteritis
• No clinical or radiological evidence of stroke within the last 3 months.
• Patients covered by health care insurance (social security)
• Written informed consent obtained.

Exclusion criteria

• Symptoms onset more than 4.5 h prior to infusion start or undetermined time of symptom onset.
• Minor VA deficit or VA rapidly improving before start of infusion.
• CRAO without foveal ischemia.
• Other retinal vascular disease: occlusion of branch of the CRA without significant VA loss, occlusion of the retinal vein, proliferative diabetic retinopathy or any other severe retinopathy.
• Clinical or laboratory evidence of temporal arteritis.
• Evidence of ICH or ischemic stroke on the pre-administration CT scan or MRI.
• Pregnant or lactating women
• Minors
• Adults under guardianship or trusteeship
• Any contraindication to alteplase
• Any contraindication to aspirin