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)

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 3

Conditions: Central Retinal Artery Occlusion

Treatments: Drug: placebo IV; Drug: Placebo Oral Tablet; Drug: Alteplase; Drug: acetylsalicylic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03197194

RC17_0061

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

A : Alteplase

Experimental group

Description:

Intravenous injection of Alteplase and one tablet of placebo

Treatment:

Drug: Alteplase

Drug: Placebo Oral Tablet

B : Acetylsalicylic Acid

Active Comparator group

Description:

one tablet of Acetylsalicylic Acid and one dose of IV placebo

Treatment:

Drug: acetylsalicylic acid

Drug: placebo IV