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

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the THEIA study is to determine if Alteplase administrated within 4.5 hours improve visual deficit due to acute CRAO with a good safety profile.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Treatments: Aspirin; Tissue Plasminogen Activator

Criteria

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