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 (THEIA)

  • STATUS
    Recruiting
  • End date
    Oct 11, 2024
  • participants needed
    70
  • sponsor
    Nantes University Hospital
Updated on 11 May 2022

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.

Details
Condition Central Retinal Artery Occlusion
Treatment Acetylsalicylic acid, Alteplase, Placebo Oral Tablet, Placebo IV
Clinical Study IdentifierNCT03197194
SponsorNantes University Hospital
Last Modified on11 May 2022

Eligibility

Yes No Not Sure

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
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