A Phase III Randomized, Blind, Double Dummy, Multicenter Study Assessing the Efficacy and Safety … (NCT03197194) | Clinical Trial Compass
CompletedPhase 3
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
France70 participantsStarted 2018-06-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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