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

Phase 3

Completed

• Conditions: Central Retinal Artery Occlusion
• Interventions: Drug: Alteplase; Drug: acetylsalicylic acid; Drug: Placebo Oral Tablet; Drug: placebo IV

• Registration Number: NCT03197194
• Lead Sponsor: Nantes University Hospital

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-22
• Study First Posted: 2017-06-23
• Study Start: 2018-06-08
• Status Verified: 2024-01
• Primary Completion: 2024-01-16
• Study Completion: 2024-01-16
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A : Alteplase	Placebo Oral Tablet	Intravenous injection of Alteplase and one tablet of placebo
B : Acetylsalicylic Acid	placebo IV	one tablet of Acetylsalicylic Acid and one dose of IV placebo
A : Alteplase	Alteplase	Intravenous injection of Alteplase and one tablet of placebo
B : Acetylsalicylic Acid	acetylsalicylic acid	one tablet of Acetylsalicylic Acid and one dose of IV placebo

Primary Outcome Measures

Name	Time	Method
visual acuity (VA) improvement after treatment	1 month	Improvement of the VA is defined by a gain of 15 letters or more on the ETDRS VA chart or ordinal scale

Secondary Outcome Measures

Name	Time	Method
Visual field	3 months	Visual field at 3 months.
Tolerance	3 months	Number, type and grade of severity of adverse drug reactions
Time course of VA on ETDRS chart or ordinal scale	3 months
Quality of life related to vision (NEI-VFQ-25) after treatment	3 months
Time-to-treatment administration impact on VA evolution.	1 month	Mean VA improvement according to the time between onset of sign and treatment administration
Global disability (modified Rankin scale) after treatment	3 months
Proportion of blindness patients after treatment	1 month	Blindness is defined according to WHO revised categories of visual impairment, as VA \< 1/20 (\< 20/400 or \> 1.3 log.MAR) or visual field \< 10.

Trial Locations

Locations (17)

CHU Rouen; 🇫🇷 Rouen, France

Ch Perpignan; 🇫🇷 Perpignan, France

CH Annecy Genevois; 🇫🇷 Annecy, France

CH métropole Savoie; 🇫🇷 Chambéry, France

CHD Vendée; 🇫🇷 La Roche-sur-Yon, France

CH de La Rochelle; 🇫🇷 La Rochelle, France

CHU de Nice; 🇫🇷 Nice, France

CHU de Montpellier; 🇫🇷 Montpellier, France

CHU; 🇫🇷 Lyon, France

CHU Caen; 🇫🇷 Caen, France

Fondation Ophtalmologique Rothschild; 🇫🇷 Paris, France

CHU de Nantes; 🇫🇷 Nantes, France

CH de Saint Nazaire; 🇫🇷 Saint-Nazaire, France

CHU de Rennes; 🇫🇷 Rennes, France

CHU de Toulouse; 🇫🇷 Toulouse, France

CHU de Tours; 🇫🇷 Tours, France

CH Vannes; 🇫🇷 Vannes, France